Q: Question about system validation: My facility was recently acquired by a bigger company. They want to implement their validated global computer system at our local site.
Is it necessary for us to develop our own local user requirements document — or can we just accept their user requirements, considering we intend use the system the same way?
A: I’d leverage as much of the existing system validation documentation and user requirements as you can.
Still, you need to make sure your local processes and procedures are reviewed and approved by the new parent company and that your people are properly trained on the new system.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]You should conduct on-site testing to ensure you can access the system and that it’s reliable and responsive.[/pullquote]
You also should conduct on-site testing to ensure you can access the system and that it’s reliable and responsive during normal operations. I’ve seen cases where adding just one new site makes a so-called global system slow down to the point where people have to develop work-arounds to get their jobs done.
Answered by Martin Browning, EduQuest’s president and co-founder. Martin also is the developer and lead instructor for EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 course, offered publicly and as an on-site, on-demand training class.