Merit Matters Blog

An Introduction to Supply Chain Traceability and Recalls

nospam@example.com (Josh Richards) — Mon, 17 Jun 2013 15:35:00 -0400

Unlike twenty years ago, manufacturers today no longer relinquish responsibility for a product once it is delivered. Now, consumer recalls are weekly occurrences: problems like bacterial contaminations, sterility assurance risks, undeclared ingredients, metal / glass / plastic particles, and oversized tablets have highlighted the need for Life Sciences manufacturers to know exactly where ingredients came from, where they went, and even what machinery they were processed on.

Perhaps this was best summed up by Susan J. Wilkinson, a Smarter Food Supply Networks Subject Matter Expert, with IBM Global Business Services, who wrote “Consumers and governments now hold brand owners fully responsible for everything related to their products,” (FoodLogistics.com, May 2012.)

Here's the bottom line: traceability is an essential aspect of the modern manufacturing environment. Also known as “track and trace,” if it isn't already, traceability should be an integral part of a Life Sciences organization's quality management system.

What does traceability mean?

In its simplest terms, traceability means knowing where a product came from and where it went. It's achieved by giving each unit of production a unique identification code – often a batch or lot number – and logging that through the manufacturing process. Extending the use of these codes to suppliers and customers results in what's often referred to as “one up, one down,” traceability across the supply chain.

Since manufacturers by definition “assemble,” the material or source information has to be linked to the recipe or bill of material. Thus traceability requires an ERP system with the ability to link suppliers, deliveries, and product identification codes to the manufacturing batches and eventual process output.

Regulation and Granularity

In the early days of traceability, lot or batch-level record-keeping was sufficient. However, in many industries, and especially the Life Sciences, a combination of consumer demand and government regulation are driving an increasing level of granularity, down to the individual item.

For an example, look at the Guidance Note on Medical Device Tracking issued by the FDA in January 2010. Addressing the requirements of the Safe Medical Devices and other Acts, this states that “Device tracking is intended to ensure that the Food and Drug Administration (FDA) can require a manufacturer to promptly identify product distribution information and remove a device from the market.”

Traceability and Recalls

When a processing fault or error is discovered, the responsible manufacturer halts production and quarantines goods that might be affected. In many cases though, this is not sufficient to protect the end customer as short lead times and minimal supply chain inventory mean every product is made and shipped as quickly as possible. As a result, if a processing or production problem is discovered the affected goods could be many miles from their origin.

At this point the manufacturer is into a recall situation. All those customers who may have received defective goods have to be contacted and the items recovered. The expense of performing a recall can be huge but easily outweighed by the cost, in terms of reputation damage and lost business, of doing nothing. As a result, many recalls are carried out voluntarily, although agencies such as the FDA have the power to force a recalcitrant manufacturer's hand if necessary.

Importance of Traceability

Traceability lets a manufacturer minimize the size and scope of a recall by providing detailed information about the source, processing and distribution of raw materials and finished goods. The more granular the record-keeping - even down to the discrete item level - the smaller a recall can be. Traceability out to the end-user or customer also helps the manufacturer verify that every affected item has been retrieved, providing a measure of recall effectiveness.

When track and trace thinking is integrated within a single ERP and Quality Management System, an organization can respond quickly, minimizing possible adverse consequences. In turn, this protects the brand, showing that traceability is good for business.

No one chooses to get into a recall situation, but occasionally errors are made. An effective traceability system minimizes negative business impacts while protecting end-users and satisfying regulatory authorities.
Learn about the Top 6 Benefits of Supply Chain Traceability in a Recall Situation.

Introduction To Electronic Batch Records

nospam@example.com (Josh Richards) — Wed, 12 Jun 2013 06:12:00 -0400

What are Batch Records?

Batch Records are something every pharmaceutical manufacturer has to deal with – they are the documented history of all the production activities that took place to produce a batch of a product. This includes documentation on when a batch was produced; what raw materials and ingredients were used in the batch; and any quality testing processes and results that were captured during production. The purpose of Batch Records are to define the set of requirements and specifications that will ensure a manufacturer will consistently produce a batch with high quality.

Historically, most Life Sciences companies manage Batch Records separately: they use an ERP system to track their business, and they use a quality management system or manual, paper-based systems to track their batch records. Normally, what this ends up meaning is that the Quality Manager has binders and binders and binders of data in their office with all the paperwork records detailing the production history of all their materials. At best, these binders are scanned into corporate “shared” drives and the company uses monster PDFs as their Batch Records. But it’s all replicated data from their core business system.

In these instances, batch processes are typically slow, redundant, and error prone. Manual processes require additional time for things like printing, sharing, and approving. They require taking the time to copy data from one system to another. And manual processes are also subject to operator discretion, judgment, and interpretation. Unlike you or me, an electronic system will do a programmed task exactly the same way every time. Humans are subject to sleep deprivation, attention lapses, bad attitudes and bad days. While a human production supervisor working in the context of a paper-based system might forget to consult the proper logs of quarantined materials, a properly programmed computer will never make that mistake or never forget to prompt an operator to complete required steps for quality control.

What these Life Sciences companies need is an electronic system that can eliminate the paper-work, optimize manual and redundant processes, and streamline batch production.

What are Electronic Batch Records?

The idea behind an Electronic Batch Record system is simple. You have an ERP system, like Microsoft Dynamics AX, that is giving you an opportunity to record all the details of what it takes to make a product – you’re using the inventory transactions, the production recording transactions, the quality tests and quality orders. The system is tracking ALL of the activity associated with the production of a batch or product. Instead of using a paper-based system, an Electronic Batch Records system simply leverages that data collection engine that is your ERP system and uses it as a system of record to systematically produce a formal Electronic Batch Record or Master Batch Record showing all the materials, activities, and processes that went into producing a product.

Electronic Batch Records provide a way to automatically compile batch production data into a commonly formatted document that will replace paper records and keep track of everything that has affected the batch. Leading EBR systems integrate production, quality control, and product safety document management process to include data from processes and equipment used, raw materials consumed, quality data and test results, deviations and non-conformances, electronic signatures, and more! They also feature complete electronic document management capabilities, including automated workflows, audit trails, and full versioning support that would enable compliance with FDA 21 CFR Part 11 regulations.

Why are Electronic Batch Records important?

Electronic Batch Records help pharmaceutical companies eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving quality and efficiency. They also help reduce error rates and operating costs, facilitate much quicker throughput, and provide a much higher degree of reliability, such so that when the FDA comes in and wants to see an example of your batch records to audit the accuracy and the effectiveness of your batch record system – there is an automated and electronic system in place that enforces all of those quality and compliance standards.

Learn more about the benefits of Electronic Batch Records in our blog article: Top 7 Benefits of Electronic Batch Records.

McGladrey LLP Announced as MAXLife Reseller

nospam@example.com (Josh Richards) — Tue, 11 Jun 2013 15:01:03 -0400

Merit Solutions, Inc., announced today that they have signed a reseller agreement for MAXLife ERP software with McGladrey LLP, the largest U.S. provider of assurance, tax and consulting services focused on the middle market. The signing of this agreement will enable McGladrey LLP to provide clients in the BioTech, BioMed, Medical Device, and Pharmaceutical industries with the leading Life Sciences ERP software solution built on Microsoft Dynamics AX.

“McGladrey is committed to providing clients with the most comprehensive life sciences quality and compliance management capabilities for Microsoft Dynamics AX,” said Bob Bell, director of Microsoft Dynamics AX practice with McGladrey LLP. "The industry-specific improvements offered by MAXLife is going to transform the way our clients maintain product quality and regulatory compliance. Our customers are going to be able to overcome stringent industry challenges, such as, 21 CFR Part 11 Compliance, CAPA, Electronic Batch Records, System Validation, and more, to sustain profitability and growth. This announcement strengthens the value we can provide to the life sciences industry and will further enable McGladrey clients to maximize the ROI from their technology investments.”

MAXLife ERP is based on Microsoft’s most advanced and feature-rich ERP system, Microsoft Dynamics AX, and extends the solution to help life sciences companies improve product quality and safety, reduce organizational risk, and maintain FDA compliance. By using MAXLife ERP, life sciences companies can automate, grow, and transform their business with innovative, high quality business process and IT consulting services designed specifically for FDA Regulated companies.

MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint for use by life sciences companies in the following areas:

Electronic Batch Records
Quality Document Management
Enhanced Audit Trails and Electronic Signatures for 21 CFR Part 11 Compliance
Corrective and Preventive Action (CAPA) Incident Management
Material Control and Recall Management (Lot Traceability)
Training and Certification Management (Learning Management)
System Validation
Enhanced Approval Controls and Quality Orders
and more!

"McGladrey is an exciting partnership opportunity for MAXLife, and a welcome addition to our global network of top performing, vertically focused Microsoft Dynamics AX resellers," said Bill Burke, CEO of Merit Solutions. "The McGladrey team brings a wealth of knowledge and experience to our partnership network and we believe their clients will benefit tremendously from our life sciences ERP Software technology. This alliance strengthens our global reach and further exhibits MAXLife’s momentum as the industry-leading Life Sciences ERP solution for Microsoft Dynamics AX. Merit Solutions looks forward to further supporting high quality partners such as McGladrey as we continue to grow and expand."

About McGladrey Technology Consulting
McGladrey understands how people, processes and technology interact to ensure organizational effectiveness. By combining technical expertise and business savvy with a full scope of IT services, McGladrey can assess complex situations, and devise and implement effective solutions quickly and cost effectively. For more information, visit www.mcgladrey.com/technology, join the McGladrey Technology Consulting Facebook fan page, follow us on Twitter @McGladreyTech, @McGladreyERP, @McGladreyCRM, and/or connect with us on YouTube.

About McGladrey
McGladrey LLP is the leading U.S. provider of assurance, tax and consulting services focused on the middle market, with more than 6,500 people in 75 offices nationwide. McGladrey is a licensed CPA firm and serves clients around the world through RSM International, a global network of independent assurance, tax and consulting firms. McGladrey uses its deep understanding of the needs and aspirations of clients to help them succeed. For more information like us on Facebook at McGladrey News, follow us on Twitter @McGladrey and/or connect with us on LinkedIn.

About MAXLife ERP
MAXLife ERP addresses the industry-specific needs of Life Sciences companies that produce FDA regulated products. Unlike other ERP systems, MAXLife is an end-to-end solution that addresses a Life Sciences company’s biggest challenge: quality management. MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint enables quality control and quality assurance processes to work together as part of the business system, and to be transparently available for reviewing and reporting. With MAXLife ERP, Life Sciences companies can track product quality, proactively see and respond to manufacturing variability, meet GMPs, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

MAXLife ERP has passed the Software Solution Test for Microsoft Dynamics AX, which is a major requirement for Certified for Microsoft Dynamics® (CfMD) status.

"Dynamic Business Applications" Designed For People

nospam@example.com (Josh Richards) — Fri, 07 Jun 2013 13:36:39 -0400

Today’s business management solutions, particularly enterprise resource planning (ERP) solutions, are evolving from a focus on transactions and data entry to one that places people and usability at the center of solution design. This includes attention to varying work styles, role-based perspectives on information and tasks, and the need to extract information in the context of business processes. This shift is being driven by workers’ dissatisfaction with rigid solutions that fail to integrate cross-business processes; adapt to changing global markets; or address the needs of individuals in different kinds of jobs. This inflexibility results in poor usability, both for the individual worker and for the solution’s fit with company-wide business processes and requirements.

According to the Forrester Research study, The Dynamic Business Applications Imperative, there is a shift toward “Dynamic Business Applications” that is helping to address this challenge. Dynamic business applications are designed for people; they greatly enhance usability and accommodate business agility to help organizations capture the full benefits of their solution. This design-for-people approach places the workers’ contextual tasks at the center of the application’s interface. The tasks, or work, are the basis for all transactions, business processes, collaboration efforts, and tools. Transactional processing and performance are still relevant, but people become the most important element of the solution.

Microsoft Dynamics AX is a leading example of a business management solution designed to optimize usability, improve user productivity, and meet the needs of people in a variety of roles to drive business success. The solution’s user-friendly navigation, familiar interface, visualization aids, and self-service business intelligence (BI) tools are prime examples of highly usable features that are designed for the people who use them.

A solution that’s accessible and relevant to a variety of people can contribute significantly to business success. Although the usability of a business management solution is only one aspect of productivity, it is critical because it can constrain or magnify all other productivity benefits of the solution.

Financial Dimensions in Microsoft Dynamics AX 2012

nospam@example.com (Marijana) — Tue, 04 Jun 2013 10:28:40 -0400

As you are surely aware the financial dimensions in AX 2012 are a bit more complex than in previous versions. Recently I was asked to fetch a description of the custom financial dimension value. Values and descriptions of financial dimensions can be found in various tables in the system depending on the dimension type. If the dimension is designated to use values from an existing table, all the financial values can be found in that specific table. On the other hand, if the dimension is designated to use values from the “Custom dimension”, the user is required to provide the set of values with their descriptions to be used as a custom list.

All the custom values are stored in the table named DimensionFinancialTag. Following you can see the simple method which returns description for a custom dimension value. The example shows the relations between tables responsible for custom financial dimensions.

/// <summary>
/// Find description for custom financial dimension value
/// </summary>
/// <param name="_dimensionValue" />
/// Financial dimension value
/// </param>
/// <param name="_dimensionAttributeName" />
/// Dimension attribute name
/// </param>
/// <returns>
/// DimensionValue description
/// </returns>
/// <remarks>
/// Only for custom financial dimensions
/// </remarks>
public static Description findDimensionValueDescription(DimensionValue _dimensionValue, Name _dimensionAttributeName)
{
     DimensionFinancialTag dimensionFinancialTag;
     DimensionAttributeDirCategory dimensionAttributeDirCategory;
     DimensionAttribute dimensionAttribute;

     select firstOnly Description from dimensionFinancialTag
     where dimensionFinancialTag.Value == _dimensionValue
     join DirCategory from dimensionAttributeDirCategory
     where dimensionAttributeDirCategory.DirCategory == dimensionFinancialTag.FinancialTagCategory
     join RecId from dimensionAttribute
     where dimensionAttribute.RecId == dimensionAttributeDirCategory.DimensionAttribute
     && DimensionAttribute.Name == _dimensionAttributeName;

return dimensionFinancialTag.Description;
}

Top 6 Benefits of Supply Chain Traceability in a Product Recall Situation

nospam@example.com (Josh Richards) — Fri, 31 May 2013 09:33:25 -0400

Almost twenty-five years ago a well-known beverage manufacturer discovered traces of benzene in a sample of its product. A worldwide recall was quickly launched - but the firestorm of publicity devastated sales, profits slumped, and after two years the company was bought out by a competitor.

Supply chain traceability technology has advanced dramatically since that time and manufacturers have many more tools at their disposal. This hasn't driven the risk of an adverse event or non-conformance incident to zero, but it has given businesses the ability to respond quickly and effectively.

An overview of Supply Chain Traceability

Let’s consider the pharmaceutical industry for a second. With an estimated market size of $300 billion in annual sales, there is a very large monetary opportunity for sophisticated drug counterfeiters. In fact, drug counterfeiting has increased sixfold over the past decade. Some industry executives believe that 10% of all drugs on the market are fake “knock-offs”; that number can increase up to 50% in poorer regions and countries. In an effort to ensure consumer safety and keep as many counterfeit drugs off the market, government agencies, partners, and consumers alike are continuously increasing their already stringent traceability requirements.

The increasing demands for regulation and easy access to real-time data have made traceability programs and systems a necessity for any Life Sciences manufacturing and distribution company. Traceability is the core of most global regulations. Two concepts underpin traceability; data retention should be “one up, one down”, and every product should have a known and documented “pedigree”.

The capability to track a product using the “one up and one down rule” combines collecting appropriate information about both the source of raw materials or ingredients and their destination, organizing the information, and retrieving it as required. Linking that source data to specific, identifiable units of production within your own manufacturing operation creates a “pedigree” for each batch, lot, case or carton. Connect that to the distribution network and it's possible to determine not only when and where a particular item in a store or warehouse was manufactured, but also when its component / ingredients were produced, where they came from, and what people, processes, and technology they touched.

Benefits of Supply Chain Traceability in a Recall Situation

Life Sciences product recalls are not predictable - they can happen at any time. At any given moment, companies must be able to quickly and effectively recall products that have been deemed unsafe for the market. How a company responds to these situations is critical: failure to handle a recall successfully (either voluntary or mandatory) can have serious economic and legal consequences. With the ever increasing levels of press and public backlash associated with consumer safety and product recalls, it is becoming even more important for FDA-regulated companies to have preventative tools and controls in place to ensure safety, monitor quality, measure the potential impact of any quality incidents, and quickly and effectively perform investigations and recalls.

A well-constructed Life Sciences ERP traceability system can be a tremendous asset in such circumstances. Here's how:

Minimize recall size: Since it's clear what product is at risk, where it went, and when, it's possible to go straight to the distributors and even retailers carrying the affected product. This keeps both the costs and visibility of the recall low.
Respond quickly: Information can come from many sources. A supplier may detect a problem after the event, a customer could find a defective product, or internal process monitoring, control and inspection activities might unearth an issue. (“Bi-directional” traceability makes it possible to work through the supply chain in either direction.) The linkage with ERP through recipes and formulas, supplier information, and customers makes it possible to retrieve “pedigree” information rapidly and to know where the affected product went. This can be pulled up as actionable data for those working on the recall.
Data integrity: Traceability systems that are an integrated component of your ERP systems – connecting multiple departments along the supply chain, including sales, production, quality, and distribution - reduces keying errors and generates reliable data. This minimizes uncertainty and confusion during a recall, and helps to reduce its scope and scale. It also ensures there's data to know when every at-risk product has been recalled.
Maintain customer trust and confidence: An aura of competence is created when a manufacturer is clear about what lot numbers, batches, or distribution outlets are affected. This reassures customers that the situation is under control and there's no risk to them.
Data for liability claim protection: Effective traceability forms the basis of systems that ensure every at-risk item is removed from shelves, protecting a company against claims of negligence. And don't overlook that an effective traceability system is actually a way to build competitive advantage since it lets a company respond quicker and more effectively than can less far-sighted competitors.
Pain reduction: Reporting on the benzene contamination recall in May 1990, the LA Times noted that, “the costs associated with the recent recall… result[ed] in a 75% plunge in earnings for 1989.” It's not possible to say with any certainty that a modern traceability system would have lessened the costs, but given the tools now available, it seems reasonable to believe so. Should your business ever be involved in a recall, effective traceability will lessen the pain.

A recall can be devastating to a business. Rapid, accurate response is essential when the risks to brand equity and reputation are so high.

This is not to say that all Life Sciences companies must have end-to-end Life Sciences ERP or recall management systems. In fact, there are more companies running on spreadsheets and manual paper processes than on industry-specific ERP. However, as these companies grow, as their business processes and supply chains become more complex, as customers become more demanding, and as regulatory compliance becomes increasingly stringent - it will become more difficult for these companies to manage the two key requirements for a good recall process: recall accuracy and response time.

MAXLife ERP and its Materials Control Workbench streamline and automate the recall process, enabling companies to not only perform effective product recalls, but to provide concrete documentation and proof that your company followed all FDA recall procedures. By using MAXLife ERP, companies are given full transparency into the recall process, allowing them to better track the status of a recall, confirm that all of the recalled product was pulled, and quickly notify the customers affected by the recall.

Microsoft Dynamics AX Pharmaceutical ERP Software

nospam@example.com (Josh Richards) — Tue, 28 May 2013 15:35:16 -0400

The Pharmaceutical industry is often considered a leader when it comes to the utilization of new, innovative technology to drive major advancements in R&D. However, we have found that when it comes to compliance, inventory, manufacturing, and supply chain management business processes – many Pharmaceutical companies still find themselves buried in paper or using 20 year old technology.

Today’s industry leaders are using Pharmaceutical ERP Software like MAXLife for Microsoft Dynamics AX to achieve compliance, eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.

MAXLife Pharmaceutical ERP Software includes extended functionality for:

Electronic Batch Records
Quality Document Management Portal
Corrective and Preventive Action (CAPA)
Software Validation
Enhanced Audit Trails and Electronic Signatures for 21 CFR Part 11 Compliance
Support for cGMP, HACCP, ISO, and other Compliance Regulations
Material Control and Recall Procedures (Lot Traceability)
Expanded Approval Controls
Enhanced Quality Orders
Training and Certification Management (Learning Management System)
Cost of Quality Management
and more!

MAXLife ERP is based on Microsoft's most advanced and feature-rich ERP system, Microsoft Dynamics AX. Gartner, Inc. has named Microsoft Dynamics AX a “Leader” in its ERP Magic Quadrant, and Nucleus Research has found that Microsoft Dynamics AX customers achieve returns in areas of increased visibility, increased productivity, and reduced costs.

Learn more about MAXLife: Microsoft Dynamics AX for Pharmaceuticals ERP Software

AKA Enterprise Solutions Announced as MAXLife Reseller

nospam@example.com (Josh Richards) — Thu, 23 May 2013 13:56:00 -0400

AKA Enterprise Solutions, a leading Microsoft Gold Certified Partner dedicated to the implementation, training and support of Microsoft Dynamics AX for Life Sciences companies, announced today that they have signed a Reseller Agreement with Merit Solutions, Inc. to resell their MAXLife ERP software. The signing of the Reseller Agreement will enable AKA Enterprise Solutions to provide clients in the BioTech, BioMed, Medical Device, and Pharmaceutical industries with the leading Life Sciences ERP software solution built on Microsoft Dynamics AX.

“For more than two decades, AKA Enterprise Solutions has been committed to providing clients with the precise technology and consulting solutions to meet their unique business needs,” said Ronald Haantjes, Vice President of Client Relations, AKA Enterprise Solutions. "The industry-specific improvements offered by MAXLife is going to transform the way our clients maintain product quality and regulatory compliance. Customers will be able to overcome stringent industry challenges - like 21 CFR Part 11 Compliance, CAPA, Electronic Batch Records, System Validation, and more - in order to sustain profitability and growth. This announcement strengthens the value we can provide to the Life Sciences industry and will further enable AKA Enterprise Solutions clients to maximize the ROI from their technology investments.”

MAXLife ERP is based on Microsoft’s most advanced and feature-rich ERP system, Microsoft Dynamics AX, and extends the solution to help Life Sciences companies improve product quality and safety, reduce organizational risk, and maintain FDA compliance. By utilizing MAXLife ERP, Life Sciences companies can automate, grow, and transform their business with innovative, high quality business process and IT consulting services designed specifically for FDA Regulated companies.

MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint for use by Life Sciences companies in the following areas:

Electronic Batch Records
Quality Document Management
Enhanced Audit Trails and Electronic Signatures for 21 CFR Part 11 Compliance
Corrective and Preventive Action (CAPA) Incident Management
Material Control and Recall Management (Lot Traceability)
Training and Certification Management
System Validation
Enhanced Approval Controls and Quality Orders
and more!

"AKA Enterprise Solutions has long been recognized as one of the leading Microsoft Dynamics AX partners worldwide. They are a very exciting partnership opportunity for MAXLife and a welcome addition to our global network of top performing, vertically focused Microsoft Dynamics AX resellers," said Bill Burke, CEO of Merit Solutions. "The AKA team brings years of experience working with Microsoft Dynamics AX in a Life Sciences / FDA regulated environment, and we believe their clients will benefit tremendously from our Life Sciences ERP Software technology. This alliance strengthens our global reach and further exhibits MAXLife’s momentum as the industry-leading Life Sciences ERP solution for Microsoft Dynamics AX. Merit Solutions looks forward to further supporting high quality partners such as AKA Enterprise Solutions as we continue to grow and expand."

About AKA Enterprise Solutions

For more than two decades, AKA has been one of the country’s leading Microsoft Gold Certified partners providing clients with superior delivery, implementation, service and support of Microsoft Dynamics offerings such as Dynamics AX, GP and CRM and Business Intelligence (BI). AKA understands, develops and, most importantly, integrates leading solutions for life sciences clients. AKA has been awarded six out of the past ten years as one of the top three Microsoft ERP partners worldwide. More information about AKA Enterprise Solutions can be found at http://www.akaes.com.

About MAXLife ERP

MAXLife ERP addresses the industry-specific needs of Life Sciences companies that produce FDA regulated products. Unlike other ERP systems, MAXLife is an end-to-end solution that addresses a Life Sciences company’s biggest challenge: quality management. MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint enables quality control and quality assurance processes to work together as part of the business system, and to be transparently available for reviewing and reporting. With MAXLife ERP, Life Sciences companies can track product quality, proactively see and respond to manufacturing variability, meet GMPs, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

MAXLife ERP has passed the Software Solution Test for Microsoft Dynamics AX, which is a major requirement for Certified for Microsoft Dynamics® (CfMD) status.

Bad Processes Forced by ERP System?

nospam@example.com (Josh Richards) — Thu, 16 May 2013 10:48:53 -0400

We recently asked the CEO of a large multinational organization why they were changing their ERP system. “To improve our business processes,” he replied, stating one of the most widespread drivers companies have to change their ERP systems. As you evaluate your ERP system with regard to business processes you should first assess the level to which any bad business processes are forced on you by your ERP system; and then identify the number of disparate and sidebar systems users have created to work around your ERP. If you find significant process issues in these areas, a change to a modern ERP system that can help you differentiate your business may be beneficial to your organization.

The functionality and capabilities inherent in your ERP software have a big impact on your business processes. As you assess the effectiveness of your current system, you must first review your core business processes to determine if they enable maximum efficiency and productivity. If they do not, investigate whether the software system imposes constraints on your processes. Are your users saying “I do this because that’s the way the system makes me do it”?

When ERP systems were introduced 20 years ago, they were rigid in their functionality. They forced companies to conform business processes to the dictates of the software, or required them to significantly customize the software to meet their specific requirements. However, business processes evolve over time while the software remains static. This causes a disparity between the way the software was originally implemented and the new requirements of the business. This evolution continues until you get to the point that the processes in the system actually constrict the ability of users to efficiently run your business. In common with the CEO mentioned above, this is a major reason why your company might end up implementing a newer, innovative, and proactive ERP system.

New enterprise ERP software applications like Microsoft Dynamics AX offer flexible business processes based on best practices and process tools such as workflow. Workflow is the ability to set up and change process flows within the system. It includes many capabilities such as electronic routing
of documents, event notification, and automated processes based on triggers. Many ERP vendors offer flexible rules-based workflows
that allow businesses to create custom processes based on their operations. These workflows can be changed as their preferences and requirements evolve. In some of the more sophisticated systems, power users are even able to diagram and implement new workflows with drag-and-drop technology. Such flexibility allows the ERP system to evolve with changes in business processes and practices in your company and industry.

As you assess the effect of your current ERP software on your business processes, you should consider the following questions:

Do your current business processes decrease efficiency and productivity?
Are they in place to make up for inefficiencies in the ERP system?
Have they been dictated by the system because of lack of functionality?
Have your business requirements changed over the years making the reasons you selected your current system no longer valid?
Have users created many sidebar and workaround systems outside the ERP?

Implementation of a flexible ERP system like allows your company to take advantage of new capabilities, functionality, and fresh ideas. An implementation partner that understands business process optimization and is industry expert is an excellent resource for efficiently implementing the system and effectively setting up your business processes. Selection and implementation of a modern ERP system can reduce manual processes, eliminate redundancy, and reduce paper documentation giving your company the opportunity to:

Review all business processes in place and determine which are required, which can be modified, and which can be eliminated.
Identify and eliminate redundancy and manual data entry.
Standardize business processes across all departments.
Adopt the best practices available in new software to obtain greater efficiency over the current ways of doing business.
Make use of flexible workflow functionality to take advantage of automated business processes, document routing, events, and alerts.

All businesses at one time or another have to weigh the costs and benefits of retaining an older ERP system against the costs and benefits of selecting and implementing a new one. Legacy systems, although on older technology, provide companies a level of comfort—comfort that is likely at the sacrifice of increased relevant functionality and technology.

Business Intelligence (BI) in Microsoft Dynamics AX 2012

nospam@example.com (Josh Richards) — Tue, 14 May 2013 14:34:37 -0400

Microsoft Dynamics AX 2012 provides a flexible pre-built business intelligence (BI) solution for mid-market organizations. The use of built-in content—including Role Centers, analytic reports, and analysis cubes—eliminates the need to build a solution from the ground up, and therefore saves time and money. The Microsoft Dynamics AX 2012 business intelligence solution can be configured and extended to suit your specific needs with the help of Microsoft Business Intelligence development tools.

The Microsoft Dynamics AX 2012 business intelligence solution consists of the following built-in features:

Role Centers (dashboards). Thirty-two default home pages that pertain to the work needs of various user profiles in an organization.
Analysis cubes. Eleven analysis cubes that address the analytic requirements of the major functional areas within Microsoft Dynamics AX 2012—including finance, supply chain, manufacturing, professional services, and business processes.
Key Performance Indicators (KPIs). More than 60 of the most commonly used KPIs that help users evaluate the success of business activities.
Analytic reports. More than 150 analytic reports that provide insight into business data.

The pre-built BI solution can be deployed when you implement Microsoft Dynamics AX 2012 in your organization. A new intuitive, wizard-driven interface guides the user through deployment of the solution without requiring the user to have expert business intelligence skills.

By deploying the pre-built business intelligence solution as you implement Microsoft Dynamics AX 2012, your organization can start using BI capabilities as soon as the new business functionality is operational.

Top 7 Benefits of Electronic Batch Records (EBRs)

nospam@example.com (Josh Richards) — Mon, 13 May 2013 10:29:50 -0400

The Pharmaceutical industry is often considered a leader when it comes to the utilization of new, innovative technology to drive major advancements in R&D. However, we have found that when it comes to inventory, manufacturing, and supply chain management business processes – many Pharmaceutical companies still find themselves buried in paper.

While regulatory reporting and compliance requirements historically drove these organizations to work manually with paper, there have been many advancements in software technology that should be too compelling to ignore. Unfortunately, once manual and paper-based systems are in place, executives tend to stay with these systems in order to stick with their “tried and true” ways of working. And once they are awash in paper, these companies are so consumed in managing paper trails that they cease to see how crippled their operations really are.

By maintaining the status quo, these Pharmaceutical companies are ignoring the significant cost savings, efficiencies, and competitive advantages that electronic systems can provide.

The obvious challenges with historical paper-based processes are that they take a great deal of time, effort, and space to manage and maintain. Then take into consideration the added risk of human errors, overlooked requirements, and forgotten processes. And don’t forget about the raw materials and finished products sitting in the warehouse waiting for manual and paper-based processes to be completed. This represents tied up working capital and fewer inventory turns. All of this adds up to higher costs and lost profits.

Executives who recognize these challenges are refocusing their efforts in order to eliminate the paperwork and automate manual processes. They are looking for an electronic way to efficiently document any procedure, process, transaction, journal, COA, formula or recipe in a way that is compliant with 21 CFR Part 11 Regulations. This means they need built-in full document lifecycle capabilities, complete with automated workflows, audit trails, electronic signatures, approvals, versioning, and archiving. And they need all of this without paper printouts.

Today’s industry leaders that are improving performance in these areas are doing so with Electronic Batch Records (EBRs). Electronic Batch Records help Pharmaceutical companies eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.

Here are the top 7 benefits of Electronic Batch Records (EBRs) ERP Software:

Improve accuracy and consistency - Unlike humans, an automated Electronic Batch Record system will do a programmed task exactly the same way every time. Humans have moods and are subject to sleep deprivation, attention lapses, bad attitudes and bad days. Automated systems do not, and perform the same way each and every time.
Increase productivity - The most important driving force for a company's business success is its people. By providing employees with a familiar interface that quickly connects internal people - and even external business partners - to the right information and tools to work faster and smarter, companies can set the stage for increased productivity. Electronic Batch Records also eliminate time-consuming and error-prone data re-entry resulting from multiple, disparate, and paper-based systems.
Reduce cycle times - A typical pharmaceutical manufacturing cycle time falls somewhere in the 30- to 90-day range, with batch releases alone taking upwards of 60 days. These cycle times typically double in nonconformance scenarios. Electronic Batch Records enforce the consistent execution of manufacturing steps while providing an accurate, real-time view of process and deviation data. The time associated with detecting, tracing, resolving, correcting, and documenting deviations in the manufacturing process within various paper documents is virtually eliminated.
Reduce Compliance Costs - Compliance requires capturing information, accurately, organizing and retaining the information and quickly and efficiently analyzing and presenting it. This requires processes and procedures that are an integrated part of a company’s way of doing business. Electronic Batch Records systems help Life Sciences companies operate and manufacture products in a consistent and compliant manner.
Reduce Operating Costs - The biggest cost of manual processes is people. It costs companies time (money) by manually performing tasks that can and should be automated and streamlined by technology. Automated systems also reduce the risk of human errors, which can result in redundant processes, rework, or even audits. Electronic Batch Records also eliminate the large costs associated with printing, reviewing, storing and retrieving paper documents.
Increase Ability to Scale Rapidly - The idea we discuss with Pharmaceutical companies today is growing with muscle, not fat. When you grow, you have increased volumes going through your business processes, and variations in those processes based on different types of customers, orders, products, suppliers, etc. The disorganization potential of paper-based business systems is far more dangerous and prohibitive to a rapidly growing company.
Improve Decision Making - Manual and paper-based processes store data in a disconnected and difficult-to-access manner. If data related to these manual processes is required for decision making, there is often a time delay in getting the data into a consistent, usable format. And because it is costly to gather the data, many companies decide to operate without it, which leads to decisions that are less optimal and often time delayed.

Make no mistake: the transition to paperless manufacturing (moving from paper batch records to electronic batch records) can be challenging. Employee pushback, systems validation, and incomplete or inadequate identification of requirements can put your systems and processes at a higher risk of failure. However, the competitive advantages and benefits offered by the use of Electronic Batch Records in modern pharmaceutical manufacturing are real, significant, and too compelling to ignore. When properly implemented and integrated with a Pharmaceutical ERP system, Electronic Batch Records can help companies increase profitability and maintain a competitive advantage.

MAXLife Electronic Batch Records (EBR) eliminates costly paperwork errors, speeds up information distribution and collaboration, and enables strategies for improving quality and efficiency. MAXLife makes it easier for Life Sciences companies to access and track batch records, model and change complex processes, and speed time-to-market.

Top 8 Pitfalls and Challenges of Life Sciences CAPA Systems and Processes

nospam@example.com (Josh Richards) — Wed, 08 May 2013 14:59:42 -0400

Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483 observations and warning letters cite Corrective Action / Preventive Action (CAPA) incident management deficiencies.

Every Life Sciences company needs to have an effective CAPA system in place to minimize risk and ensure compliance with regulations, but maintaining an effective CAPA process can be challenging. Challenges can occur at every step of the CAPA process and it requires vigilance to ensure that they don't derail the process and expose the company to unnecessary or excessive risk.

Here are the top eight challenges of CAPA systems and processes:

CAPA Silos: The biggest challenge Life Sciences companies find themselves caught with is a silo’d CAPA system (or multiple CAPA systems) in which the data in the CAPA system(s) cannot be effectively shared across the company or cross-referenced with other data. This makes it hard for companies to link related problems – and even harder to generate metrics and perform trend analysis on elements like products, problem types, root causes, costs, and more. These companies need to break down their CAPA silos to achieve a single, managed, integrated and complete view of the process - and enable a common way for them to do trending and put preventive action in place across the company.
Complex Processes: The first step of effective CAPA systems is to create and document the process. However, companies often make the mistake of trying to build every potential exception condition or possible incident into the CAPA system – which makes it too complex for people to understand and follow. Complex systems lead to slow resolution and aging CAPAs because people are unsure of the next steps. Instead, CAPA systems and processes need to be simple, yet comprehensive – and they need to include a process for escalations and exceptions that provides guidelines but doesn't necessarily dictate specific steps that may not be appropriate in every case.
Lack of Documentation at Every Step of the CAPA Process: When people are in a hurry to resolve an issue before it escalates, they naturally tend to focus on taking the action rather than documenting the reasoning behind the action. Part of an effective CAPA process should be full documentation at every step; your people don't need to write a novel before every action, but they do need to record what they are doing and why. Be careful not to let documentation lag the CAPA process because you can lose valuable information; however, employees need to answer the “who, what, when, where, how and why” questions for every step.
Confusion between a Corrective Action and a Preventive Action: A Corrective Action generates a solution to issues that have already occurred. A Preventive Action looks for solutions to problems that might occur. Don't fall into the trap of thinking that every problem and every process change needs to have a CAPA to justify it. That will bog down your system and critical actions may not get resolved as quickly because of it. Instead, ensure that people understand the distinctions between corrective actions and preventive actions, and that they reserve them for actual or potential incidents.
Imprecise Language: If people can't state the problem succinctly, the team will be unlikely to resolve the issue or even to measure results of their actions. People often try to jump ahead to possible solutions when defining the CAPA or they get emotional in their description. Neither choice is conducive to rapid resolution, so don't tolerate sloppy problem definitions. Make sure team members are trained in writing simple, concise problem statements that highlight the difference between the current state and the future state. When people know the starting and ending points, plotting the route and measuring progress are much simpler. It also makes it simpler to determine relative priorities and risk associated with each incident of non-conformance.
Jumping to Solutions: This is often a direct result of imprecise problem statements. When people jump to conclusions about the solution to the problem before fully defining and investigating the issue, they may make "corrections” that don't correct anything. Instead, companies need to insist that every problem statement answers the "who, what, when, where, how and why," as well as the frequency and severity of the effects of the problem. Don't let panic about compliance cause people to rush through the steps, because you may end up addressing the symptoms rather than the causes of the problem.
Insufficient Process Training: After CAPA processes have been sufficiently defined, companies need to make sure to train employees in the proper steps and procedures. Many companies train people to follow the rote steps, but they don't provide training in precisely defining the problem or how to determine the severity of an issue. As a result, the CAPA system bogs down with aging or unnecessary corrective actions and preventive actions that remain open due to either insufficient resources or sheer bafflement about the actual issue. CAPA systems and processes require in-depth employee training, and frequent re-training, in order to remain effective and compliant.
Inconsistency in Applying the Process: Many companies today have multiple sites, often in multiple countries or regions. This requires extra diligence to ensure that all sites react the same way and apply procedures the same way. One of the worst situations you can have is having each site following different processes or treating equivalent incidents differently. Companies can prevent this problem with extra training (as mentioned above), and by implementing a centralized CAPA system that connects departments and locations. Don't believe any statements that "we're different" unless you investigate and agree that one site should be an exception. If there is a reason for a different process at a facility, document it and make it part of the corporate process.

It requires vigilance to ensure regulatory compliance, but effective CAPA systems and processes should be an important part of your compliance arsenal. When used correctly, your CAPA systems will help you resolve non-conformances quickly and minimize risk.

MAXLife's Corrective Action Preventive Action (CAPA) Incident Management ERP Software capabilities enable you to increase control and assuredness for how your organization operates. With MAXLife, you can generate a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. This CAPA tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of problems. It also enables companies to improve brand loyalty and customer satisfaction by continuously improving quality and responding quickly to potential incidents.

Approval Process for Purchase Orders with Microsoft Dynamics AX

nospam@example.com (Josh Richards) — Tue, 30 Apr 2013 11:25:34 -0400

Maintaining and controlling corporate spending is more critical than ever. With Microsoft Dynamics AX, it has never been simpler to ensure that an organization changes and evolves the business processes and tasks that control the procure-to-pay processes.

The approval process for purchase orders adds automation and control to purchase order processes. It also delivers a high level of flexibility in the modeling processes with policies and workflows, including task and approval management. Purchase order history and versioning is built-in and is easily accessible, providing deep insight and supporting analysis and conscious decision making.

The approval process for purchase orders ensures that the business processes have been followed and that correct review and approval has been performed, which guarantees that the purchase orders created and confirmed to the vendors have been appropriately reviewed and approved.

Approval Process Configuration

The approval process for purchase orders within Microsoft Dynamics AX 2012 provides the flexibility to control and track changes within purchase order processes, and it enables control of the approval process by using the standard workflow framework.

The key areas supported by the approval process for purchase orders are:

Activation – The purchase order approval process can be activated on different levels:

For all purchase orders
For purchase orders for a specific vendors
For individual purchase orders

Workflow – The purchase order approval process uses the standard workflow framework to define activities (such as tasks, decisions, and approvals) that need to be carried out. It provides the ability to design business processes such as company approval processes and change management policies.Both the purchase order and purchase order line have been workflow-enabled, making it possible to configure and execute different activities per purchase order line based on line conditions and properties.
Versioning – The purchase order document is versioning-enabled with activation. A new document version is created upon approval of the purchase order, and versioning ensures a complete audit trail for the changes made to a confirmed purchase order.

The Purchase Order Approval Process

After a purchase order has been entered into the system, its approval status controls the actions that can be performed. An unapproved purchase order must be approved before the purchase order can be issued to the vendor and the purchase order status is confirmed. A purchase order must be confirmed before product receipt and invoices can be matched against the purchase order.

Approval state model:

Draft – The purchase order requester creates and makes changes to the purchase order when in Draft state.
In review – The requester submits the purchase order or the request for change to an approval workflow, which will change the state to In review. The policies and processes configured within the workflow will assign and execute tasks, decisions, and approvals needed for the specific purchase order or change request. If budget control is enabled, a budget check will be performed based on budget control policies, providing real-time analytics related to budget funds available.
Rejected – A purchase order that has been rejected by a workflow reviewer has the state of Rejected. The purchase order can be changed and resubmitted to workflow if desired.
Approved – A purchase order that has completed the approval process is considered Approved, and can now be issued to the vendor. Expected receipt transactions may be created when the order reaches Approved status.
Confirmed – Confirming the purchase order generates a purchase order confirmation document, which is an external document that may be provided to the vendor to notify them of the order. If budget control is enabled, the budget check is performed based on the budget control policies and budget reservations are established ensuring that planned expenditures do not exceed budget funds available. If encumbrance processing has been enabled, subledger journal entries are created for a purchase order when the purchase order is confirmed to reflect the consumption of budget funds on the balance sheet.
Finalized – Finalizing the purchase order requires all lines to be either canceled or invoiced. After a purchase order has been finalized, you can no longer change the purchase order. Finalize the purchase order to liquidate budget reservations and any encumbrance that is not yet relieved in general ledger.

The approval process for purchase orders features provided by Microsoft Dynamics AX 2012 explicitly requires the approval of any request to change the purchase order, and the changes are not effective before approval. The feature also ensures that every change request is captured within a purchase order version, which allows for version comparison (header and lines) for analysis of changes between any two versions of the purchase order.

Displaying a File, Folder or Web Page in the Page Viewer Web Part

nospam@example.com (Boris) — Tue, 30 Apr 2013 11:12:50 -0400

The Microsoft SharePoint Page Viewer Web Part can be used for displaying a Web page, file or folder on a Web Part Page.

Note: You can use the Page Viewer Web Part only in a browser that supports the HTML IFRAME element. Displaying a file or folder requires Microsoft Internet Explorer.

Here are the steps how to do this:

Go to the correct site.
Open Site Actions and select Edit Page.
Click Add a Web Part in the section you want the web part to be displayed in.
Choose the category Media and Content and select Page Viewer Web Part. Click Add.
The Page Viewer Web Part is added to the page. Click the Edit Web Part option in order to link the contents.
A) If you want to display a web page it's very straight forward. Just select Web Page and type in a URL under Link and the URL will be displayed.

B) If you want to display a folder, type in a network path to that folder under Link and the folder content will be displayed.

C) If you want to display a file content, type in a network path to that folder along with the file name under Link (e.g. \\shared\manuals\XYZ\User Manual XYZ 2013.pdf) and the file content will be displayed.

The file opens either in a separate browser window or inside the Web Part if the application that opens the file supports inline activation for that file in the browser window.

SharePoint Client Object Model for Silverlight: Uploading Files Over 2MB

nospam@example.com (Boris) — Wed, 24 Apr 2013 13:33:15 -0400

The commonly used method for uploading files in SharePoint’s Client Object Model API is the Microsoft.SharePoint.Client.SaveBinaryDirect method.

For example, calling:

public static void SaveBinaryDirect(

ClientContext context,

string serverRelativeUrl,

Stream stream,

bool overwriteIfExists
)

should be quite enough to get through. However, when it comes to Silverlight, the developer is limited to the Microsoft.SharePoint.Client.Silverlight namespace, and the SaveBinaryDirect method is not available there. The alternative is to use the more straightforward approach by instantiating the FileCreationInformation object and to use it for adding new files to the SharePoint folder, like so:

FileCreationInformation fci = new FileCreationInformation();

...

File file = list.RootFolder.Files.Add(fci);

However, one would yet again face an issue if the size of the file that needs to be uploaded is larger than 2MB. It is necessary to fully read the file prior to calling the Add method. The following method ensures just that:

private byte[] ReadFully(Stream input)

{

     byte[] buffer;

MemoryStream ms;

     int read;

     buffer = new byte[input.Length];

     using (ms = new MemoryStream())

     {

           while ((read = input.Read(buffer, 0, buffer.Length)) > 0)

          {

               ms.Write(buffer, 0, read);

          }

          return ms.ToArray();

     }

}

Now, regardless of their size, the method for uploading files looks like this:

public File UploadFile(string fileName, Stream fileStream, bool overwrite)

{

    FileCreationInformation fci;

StringBuilder sb;

    File file;

    fci = new FileCreationInformation();

    fci.Content = this.ReadFully(fileStream); //Calling the previous method

    fci.Overwrite = overwrite;

    fci.Url = fileName;

    file = list.RootFolder.Files.Add(fci);

    return file;

}

Happy coding!