Archive for November, 2008

What is 21 CFR Part 11 ?

PrisymID have been a leading supplier of labeling software solutions to the world’s Life Sciences companies for almost 25 years including over 10 years of experience delivering labeling solutions to meet the requirements of 21 CFR Part 11. (more…)

Is Your Labeling System Really

If you are responsible for your company’s labeling system complying with FDA 21 CFR Part 11, you would have been interested in the recent presentation PRISYM ID made at the Institute of Validation’s week long conference in Philadelphia.  Our presentation ‘Are you really 21 CFR Part 11 Compliant – A DIY Audit’ highlighted the some top areas for non compliance and our own experience of solutions to these issues.

Read on to find out what these areas are and how we’ve overcome them.

(more…)