Merck* shares their best practices for simplifying CFR Part 11 compliance and system validation with engineering document management.
Learn how they gained centralized access to GxP documents of complete facilities in a secure, collaborative platform that ensures traceability, an audit trail, automated workflows, and data integrity.
John Niziolek, Director of Computer Systems Validation & Data Integrity at IPS and Scott Lamond, VP of Synergis Software break down the challenges life sciences companies face and how to overcome them.
🌟As a Bonus:
You'll get our free Guide, Conquering Regulatory Chaos in Life Sciences: Taking Control of Your GxP Digital Assets with Engineering Document Management.
*Merck Sharp & Dohme LLC, Rahway, NJ, USA (Hereinafter MSD).
With Adept I have version control. I have a central source of truth. And we control access so that only a very small pool of people can check files in and out and do editing. A larger group can view the files, print them, work with them, but they still are watermarked to show that they were printed and after a certain amount of time they expire. So, the system meets our GMP requirements, particularly 21-CFR Part 11..
Ray Kastle
Associate Director, Supply Chain
