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Convergence 2014: Microsoft Dynamics AX Life Sciences Networking Lunch

For the second year in a row, Merit Solutions is proud to sponsor the AXUG Life Sciences Special Interest Group (SIG) networking lunch at Microsoft Convergence 2014.

This Life Sciences SIG lunch provides current users of Microsoft Dynamics AX in the life sciences industry to come together and network, share challenges and best practices, and discuss potential solutions for specific business needs. And since this is a customer-only event, they can do all of this without fearing being "sold to" by any Microsoft Dynamics AX partners.

Space is limited for this event and registration is required to attend. Please only register if you will attend.

AXUG Life Sciences SIG Networking Lunch at Convergence 2014:
Thursday, March 6th
Dantanna's Downtown
12pm - 2pm

If interested, feel free to join the Life Sciences SIG Group on AXUG Collaborate to stay connected and up-to-date on future events.

Osmotica Pharmaceutical Customer Spotlight

We recently had the opportunity to speak with Donna Lenning (IT Director) and Kelly Moore (QA Documentation Manager) from Osmotica Pharmaceutical, a global drug delivery company based in the US.

Donna and Kelly were gracious enough to discuss their experiences working with Merit Solutions, the benefits they have received from MAXLife's Pharmaceutical ERP for Microsoft Dynamics AX functionality, along with the Quality Document Management and Training and Certification Management MAXLife SharePoint applications.

We hope you enjoy their feedback! 

Frequently Asked Questions about CAPA Systems

Every life sciences company needs an effective corrective and preventive action (CAPA) system in order to meet FDA compliance requirements. It’s easy to understand the need for a system, but it’s not as simple understanding exactly what the FDA requires from your CAPA system.

We hope you find this list of FAQs to be helpful.

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Understanding CAPA Software

It is essential that any FDA-regulated company have an effective CAPA system, but unless they drive the company to a confirmed solution to a quality issue, CAPA systems serve no purpose and they can waste resources. Companies are often at a loss as to what an effective CAPA system should look like, so they err by enforcing either too much control or not enough control.

At its core, an effective CAPA system should be a closed loop system, ensuring evaluation of quality input, implementation of corrective actions and evaluation of the results of the changes.

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10 CAPA Essentials for Passing your Audit

Yesterday we talked about FDA 483 Warning Letters and CAPA.

Ensuring that your CAPA system meets the FDA requirements can be complex if you rely on guesswork or if you try to memorize all the regulations relating to CAPA that the FDA publishes. Here is a simple 10 step checklist to help ensure that you have covered all the essentials.

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483 Warning Letters and CAPA

Executives in Life Sciences organizations that make regulated products have a legal duty to ensure that their company implements whatever measures are necessary to comply with the complex and stringent requirements of the FDA (and other worldwide health organizations) – and they can be held personally liable for failing to conform with regulations.

Two events that keep these executives up at night are upcoming audits and the issuance of 483 observations and warning letter citations. And unfortunately for executives, the FDA has increased the number of warning letters by 625% over the past three years, with 4,882 issued in 2012. (See FDA Inspections, Compliance, Enforcement, and Criminal Investigations for statistics from the past 4 years.)

Continue reading "483 Warning Letters and CAPA"

Life Sciences and Microsoft Dynamics AX - Approaches for Meeting Your Regulatory Requirements

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. 

Quality Management Processes in Microsoft Dynamics AX

Microsoft Dynamics AX 2012 provides a number of quality management processes that you can use to ensure a high level of product quality within your supply chain. This capability leads to optimized supply chain processes and higher customer satisfaction.

Quality management functionality in Microsoft Dynamics AX can help you manage turnaround times when dealing with nonconforming products, regardless of their point of origin. By linking diagnostic results to correction tasks, the system can schedule tasks to correct problems and therefore help prevent recurrences in the future.

In addition to nonconformance management, quality management functionality includes the ability to track issues by problem type (including internal problems) and to identify solutions as being short-term or long-term. Statistics on Key Performance Indicators (KPI) provide a window into nonconformance problems that have occurred historically and the solutions that have been applied to correct them. Historical data can be used to help review the effectiveness of quality measures that have been taken and to determine appropriate measures to perform in the future.

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Join Merit Solutions at AXUG Summit 2013

Join Merit Solutions as we attend AXUG Summit 2013 taking place October 23 - 25 in Tampa, FL.

AXUG Summit provides a conference experience unlike any other. Every attendee is focused on Microsoft Dynamics AX, and you’ll learn first-hand how they’ve overcome challenges you face every day! Take some time to explore the session lineup and learn more about the AXUG Summit experience… then make plans to join us in Tampa!

Here are a few sessions we recommend attending:

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Microsoft Dynamics AX: Gets You Up and Running Quickly

Buying a new enterprise resource planning (ERP) solution is a strategic investment for your business, so it’s well worth your time to examine your options carefully before you act. If you’ve been viewing the “Top Reasons to Invest in Microsoft Dynamics AX and Merit Solutions” blog series, thanks for following along. If you are just joining, welcome and we hope you tune in for our future reasons!

This week we’re going to discuss how we can get you up and running quickly.

To run your business in today’s fast-paced, ever-changing world, you have to be able to quickly and easily deploy comprehensive, flexible, and innovative technologies.

Merit Solutions features rapid implementation services that enable companies to speed time to value and maximize return on investment. We incorporate best practices for helping people learn the system, improve the way work is performed, and use information to increase business performance.

We also utilize industry-leading tools that make projects faster and simpler to deploy. These tools do things like simplify the configuration of your ERP solution to meet your specific requirements, and offer best practices and other guidance to find the perfect setup for your business. We have found that this alone can cut months off of a traditional ERP deployment, significantly accelerate the ERP implementation, and speed the time required to realize its benefits.

When considering ERP solutions, Microsoft Dynamics AX combines comprehensive out-of-the-box capabilities with rapid, flexible deployment options designed to get you up and running quickly and affordably. Plus, Microsoft Dynamics AX provides a user interface that is similar to other Microsoft products, which eases training and helps people reach their full potential faster.

Learn about Innovare Health Advocates’ decision to implement MAXLife Cloud ERP for Microsoft Dynamics AX – and how they got up and running within 5 weeks.