Blog

On the Horizon: MES for the Medical Device and Diagnostic Industry | IVT

Over the past decade, manufacturing execution systems have become increasingly commonplace in pharmaceutical manufacturing. However, as computer systems and software continue to evolve and improve, validating MES and remaining compliant with regulations becomes increasing more difficult. 

MES systems are some of the most complex aspects of a manufacturing plant. They incorporate hardware, software, employee computers, equipment and instruments, and relevant documentation. Validating MES and adhering to FDA, ISPE, and EU regulations requires a comprehensive change and configuration management, risk assessment, vendor qualification, and training program. This year's Forum on Manufacturing Execution Systems (MES) for the Medical Device and Diagnostic Industry discusses current problems and innovative solutions for MES implementation, validation, and compliance.

Last year, Thomas Quinn discussed 21 CFR Part 11 and other global regulations that involve MES. Despite being well-known and frequently referenced documents, there are numerous complexities of the regulations that often go overlooked. Quinn makes it very clear that both 21 CFR Part 11 and Annex 11 of the Eudralex applies to all electronic records, not only records that have been signed. There is an explanation of other global guidances to assist compliance, such as the US Food and Cosmetic Act and The Electronic Signatures in Global and National Commerce Act. Quinn also discussed the very real threat of security breaches, citing a 2011 arrest of a New Jersey-based pharmaceutical employee who intentionally damaged his companies computers. 

 




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.

Comments (0)

Post new comment

The content of this field is kept private and will not be shown publicly.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
  • Use to create page breaks.
Image CAPTCHA
Enter the characters shown in the image.