Skip to main content Skip to main navigation Skip to search Skip to footer

COTS Validation Post FDA & Other Regulations

COTS Validation Post FDA & Other Regulations

Abstract

Ever since FDA’s Quality System regulation (21 CFR 820) & Design Control were finalized in 1997 & 1998 respectively, medical device and pharmaceutical industries have been in a tizzy about the requirements for validation of commercially off the shelf software (COTS).

This paper discusses why validation is required even for off the shelf software, who is responsible for the validation and what some of the top 40 Medical Device & Pharmaceutical Research Organization are doing to meet the regulatory requirements.

Excerpts from the Paper

As  per  FDA’s  view  on  software  validation,  Medical  Device  & Pharmaceutical companies have the ultimately responsibility for the software  they  use.  This  includes  software  like  Excel,  MathCad, Matlab, Codewright, GNU Emacs etc. Whether the software is developed in-house, by a contractor, or purchased  from a vendor; Manufacturers cannot assume current Good  Manufacturing  Practices  (cGMP)  were  followed  for  the development or validation of the software. 

DOWNLOAD THE WHITEPAPER

Contact Us
MAX CHARACTERS: 10,000

We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.

We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.