Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.Continue reading "What Keeps You Up at Night? 2014 in Review for Medical Device Companies"
Entries tagged as compliance
Everyone knows that an organization has reporting requirements within their accounting departments, but an organization should think beyond financials and recognize that compliance is relevant to so much more.Continue reading "The Power and Flexibility of Dynamics AX in Compliance"
When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively delaying a response will not make it go away, the ramifications will only increase.Continue reading "When it Becomes Criminal"
Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door - or even defective product reaching the customer.
Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.Continue reading "Device Design Transfer - A Smooth Hand-off"
The bridge from product inception and or production to the customer’s hands may seem like an amicable journey. The plan is followed and milestones attained. Then QA jumps out and growls that the product can’t be released due to a potential quality issue. The result: deadlines not met, revenue not realized and workplace harmony is destroyed. Sound familiar? Well you aren’t alone.
A 2014 survey of device manufactures conducted by Compliance-Alliance found that 27% of respondents categorized QA as a “necessary evil, a deterrent to revenue or a policeman who always says no.”Continue reading "Quality and Compliance: The Ogres Under the Bridge?"
If you are a Microsoft Dynamics AX Life Sciences company attending AXUG Summit today, don't miss out on the session being led by MAXLife client Donna Lenning, IT Director of Osmotica Pharmaceuticals, as she discusses "Life Sciences and Microsoft Dynamics AX - Approaches for Meeting Your Regulatory Requirements".
More and more companies in the life sciences industry are running Microsoft Dynamics AX. In this session learn more about the various methods and approaches for setting up and configuring Microsoft Dynamics AX to meet the regulatory and special requirements the life science industry requires. Life Science SIG members are encouraged to attend this session.
The session takes place today, Thursday October 24th, from 2:30-3:30pm in room CC-31/32.
If you're like a lot of the Executives we've been talking to recently, some of your main goals and objectives for 2014 include:
- Driving growth by increasing margins, expanding into new geographies, and speeding innovation and time-to-market.
- Improving operational effectiveness by standardizing processes, increasing visibility, driving efficiency.
- Improving decision making with better access to real-time data and key performance indicators.
- Future-proofing IT architecture by meeting the profoundly more demanding IT trends of businesses today:
- Supporting BYOD (Bring your own device)
- Exploiting Big Data
- Connecting via Social Media
- Utilizing the Internet "Store"
- Mitigating risk and maintaining compliance with improved visibility, control, and security.
Do these sound familiar?
When Trading Technologies International, Inc. found themselves facing similar objectives, they decided they needed to integrate their company with a global ERP solution and streamline and standardize their business processes. Read more about how they did it - and the benefits they have received since undergoing their business transformation: Trading Technologies Implements Microsoft Dynamics AX to Optimize Processes, Extend Organizational Insight, Improve Decision Making, and Transform Their Business.
The Life Sciences 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 Life Sciences companies still find them-selves buried in paper or using 20 year old technology.
By maintaining the status quo, these companies are ignoring the significant cost savings, efficiencies, and competitive advantages that new, innovative Life Sciences ERP systems can provide.
This white paper will look at some of the key feature requirements enterprise Life Sciences companies should look consider when evaluating new Quality and Compliance ERP software. It will also identify how today’s industry leaders are using Life Sciences ERP Software like MAXLife to achieve compliance, eliminate costly paperwork errors, reduce operating costs, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.
Read the white paper: Managing Quality and Compliance: Life Sciences ERP
In 1997, the FDA enacted regulation 21 CFR Part 11, which outlines how FDA regulated industries must handle electronic signatures and electronic records. This regulation sets the standards that must be met by pharmaceutical, medical device, and bio-tech companies that wish to use an electronic business management system, like an ERP system, quality management system, and / or a quality document management system. These standards apply to all phases of Life Sciences companies, including research, manufacturing and distribution of products and services.
The FDA holds all life sciences companies and executives accountable to very stringent quality and safety standards. Companies use a mixture of electronic systems that are integrated for efficient operations. Any company that uses systems such as warehouse management, materials resource planning, enterprise resource planning, laboratory information management, or clinical trial management must insure that those systems are in compliance with the regulation.
Before proceeding any further, let’s be clear: 21 CFR Part 11 does not require the use of electronic systems and records. Instead, it establishes the criteria by which Life Sciences companies must use those electronic systems and records in a controlled manner that ensures company data and processes are as trustworthy, reliable, and secure as paper records and handwritten signatures.
During the transition to electronic records and signatures, many companies have a hybrid approach where some of their operations still use signed hardcopy documents. The issue with the Hybrid System is defining what is considered the authoritative document within these mixed environments. If a company regulated by the FDA retains paper copies of all required documents, and they stipulate that these hardcopy documents are the authoritative source, then the systems do not specifically need to meet the 21 CFR Part 11 requirements. If a hardcopy document is produced from its electronic source, there are standards as to what must be on the document for it to be authoritative.
Consider an analytical system that generates a test results document that requires the signature of the tester. If the current system does not support electronic signatures, then the user prints out the results and signs the paper document in the appropriate place. Part 11 does not make the use of electronic signatures mandatory, so this is a valid situation. The paper document and signature is authoritative when linked to the system data by making sure there is sufficient information on the printed document, such as size, date and time stamps and checksums.
In its "Scope and Application" statements, the FDA continues to review and redefine the regulations because they have been seen as overly broad and costly to implement. It is up to the regulated company to insure that all of their systems that trigger Part 11 are in compliance. That includes addressing all of the following system and process-related checks:
- System Validation- Any systems that trigger 21 CFR Part 11 must be shown to be consistent and reliable. The key is that they must demonstrate this at any time and the appropriate documentation be available for review. Should there be any changes in the system, such as an upgrade or patch, regression and integration testing must be done to make sure that the system is still compliant. The procedures to do this must be created by the company using the systems.
- Records Management - All of the standards must be met regarding how electronic records are managed throughout their entire life cycle of creation, change, maintenance, archival, retrieval, sending and receiving. As the work flow passes records back and forth between multiple systems, all of the standards must be retained.
- System Security - There are minimum standards defined for who can access information, how the access is obtained and controlled, and what is required when other electronic systems use the data. This pertains to both logical and physical information. These controls range from the password requirements for a user to view information to the way in which electronic records are made available for an FDA submission.
- Audit Trail Management - This is the most complicated standard to implement and the biggest challenge for any life science company. What should include an audit trail, under what conditions and for how long are questions every company asks. For instance, when does company email need an audit trail? What changes made during a batch process should be recorded in an audit trail? There are hundreds of points in a company that need to be considered.
It is also very important to note that no vendor can guarantee that their system is 100% 21 CFR Part 11 compliant. Administrative controls are defined by the system users. Procedural controls such as how notifications are handled, how staff are training and the content of standard operating procedures are again up to the user. The vendor can only state that their system is in compliance when used in a manner that follows the regulations.
Of course, there are costs associated with FDA 21 CFR Part 11 compliance, but the impact of non-compliance can be exponentially greater. Public awareness of an FDA warning letter can send stocks down and reduce customer and consumer trust and loyalty.
Learn more about MAXLife ERP for 21 CFR Part 11 compliance support.
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.