Maxiom Group and Sparta Systems jointly hosted a Quality Management Systems Workshop on Thursday, March 4th, 2010 in Waltham, MA. The workshop was titled “Improve Quality, Reduce Risk- Exploring QMS Earlier in the Development Lifecycle” and was attended by both life science companies that have very little QMS experience and those that have extensive knowledge about these systems. The panelists were experienced life sciences professionals from Alkermes, Mannkind and Shire HGT that have an in-depth knowledge of QMS implementations.
The workshop included a presentation by Sparta Systems and Maxiom Group followed by a panel discussion. Topics included a review of the triggers for investment, and the benefits that a Quality Management System offers. In addition, the presenters talked about the challenge of maintaining quality and compliance amid increasing complexity in the industry. Best practices when integrating QMS with enterprise applications were also discussed.
The panel took questions from the moderator and from participants which resulted in valuable discussion. Some of the themes included:
• Challenges in defining the business justification for QMS
• The importance of educating senior management about the business risks and drivers for quality
• The significance of a strategic long-term plan that implements QMS early on the road to commercial launch
• The importance of the involvement of the end users for requirements gathering and definition to ensure buy-in
• Prioritization and definition of business processes in order to focus on improvements that can bring efficiencies when automating
• The need to stay focused on the goals of a QMS implementation
Do you have any comments or additional experiences to share?
Samantha Whelan
Tags: EDMS/QMS, IT Solutions
It is important for companies to always be aware that by law and regulations they are held accountable by regulatory authorities for quality oversight. When GXP activities are outsourced, companies sometime think that the CRO/CMO QMS is “good enough”. Based on the violations listed in current FDA Warning Letters, this is not the position held by the FDA. Whether the company is virtual or big Pharma they expect a QMS to be in place.