Merck, Synergis & IPS Present on Engineering Document Management for Simplified Compliance & Validation

Engineering Document Management for Simplified Compliance & System Validation (Graphic: Business Wire)

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Synergis Software, a global leader in engineering document management and workflow solutions, today announced they will participate in a collaborative, live panel with leaders from Merck, known as MSD outside of the United States and Canada, and IPS-Integrated Project Services, LLC (hereinafter IPS), a recognized leader in Engineering, Procurement, Construction Management and Validation (EPCMV), to present one of the many ways MSD is leveraging the Synergis Adept platform to simplify compliance and validation across their global facilities.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221107005177/en/

Attendees will learn how engineering document management delivers centralized access and control of GxP documents and CAD drawings in a secure, collaborative environment to improve quality processes and simplify compliance and system validation for FDA 21-CFR Part 11 and EMA Volume 4, Annex 11.

Register now for this live 50-minute webinar, hosted by Pharmaceutical-Technology.com, taking place on Wednesday, November 9, 2022, at 8:00am ET and 2:00pm ET. You can get access to the replay here.

The three panelists include:

• Raymond Kastle, Associate Director, Supply Chain at MSD
• John Niziolek, Associate Director Computer Systems Validation and Data Integrity, IPS
• Scott Lamond, Vice President of Marketing, Synergis Software

The presentation will address the top document management concerns that life sciences organizations face in a regulated industry with a focus on MSD’s specific background, challenges, and approach.

Mr. Kastle will also share MSD’s best practices and lessons learned for implementation and user adoption. Mr. Lamond and Mr. Niziolek will share their companies’ roles in supporting MSD’s document management implementation and validation.

Key Learning Objectives:

• Lower the cost and effort of compliance and validation
• Reduce risk of noncompliance with streamlined audits
• Eliminate costly mistakes and safety issues
• Simplify collaboration and accelerate projects

“In their pursuit of simplified compliance with FDA 21-CFR Part 11 and improved data integrity, traceability, an audit trail, and record retention, MSD turned to Synergis Adept,” says Scott Lamond, vice president of marketing at Synergis Software. “Adept provides a centralized platform for document access, workflow, and control that aligns engineering, maintenance, operations, and construction teams. It empowers life sciences companies to drive standards and reduce the risk of safety and compliance issues.”

Together, Synergis and IPS bring life sciences and biotech companies the best possible solution for engineering document management software coupled with expertise and resources to ensure compliance and validation.

“IPS has developed a deep understanding of the Adept platform and the Synergis implementation process,” says John Niziolek, associate director computer systems validation and data Integrity at IPS. “Ourpartnership provides every client with a compliant, consistent implementation experience and ensures they benefit from industry leading technology that addresses their regulatory compliance concerns.”

Synergis Adept is used by many of the top life sciences/biotech companies, including Johnson & Johnson, Thermo Fisher Scientific, Bayer, Agilent, Astellas, bioMérieux, Elanco, and many others.