The Biotech Industry Should Better Understand the Consequences of a non-Validated Computer System

By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager: Sept. 09, 2011

If you are a Medical Device developer, a Biotech firm or Pharmaceutical Manufacturer, you are required to follow either 21 CFR Part(s) 210 & 211 or 21 CFR part 820. In tandem with 21 CFR Part 11, all of the computer systems used to support your manufacturing and design processes require validation. Often manufacturers make the mistake of attempting to claim that their computer systems are purely reference tools and that paper reigns. This approach has the potential to mislead, confuse and ultimately break the law. There are several citations issued by FDA including:

“Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 C.F.R. §820.70(i) (Production and Process Controls - Automated Processes).”

Why take the risk? Sidus BioData can integrate your ‘GMP’ Computer Systems into our fully compliant GMP Datacenter, and provide you with the validation documents necessary to avoid a warning, fine or worse, imprisonment.

Call Sidus BioData today! The risk just isn’t worth taking.

Phone: (410) 896-1050 x 114

or Contact Us Online (click here)