Archive for 2008

Nov 11th

Posted in FDA, Knowledge Base, Labeling Regulations

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…)

Nov 7th

Posted in FDA, Labeling Regulations

Is Your Labeling System Really 21 CFR Part 11 Compliant

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.

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Oct 14th

Posted in GS1, Labeling Regulations

GS1 Healthcare Newsletter

The twelfth edition of the GS1 Healthcare newsletter has been released, with a special feature on the PRISYM ID Life Sciences blog! (more…)

Sep 15th

Posted in GS1, Labeling Regulations

How is GS1 Affecting Your Business?

GS1 bar code standards have been implemented into our core software but until very recently none of our life sciences customers have asked us if our solutions are GS1 compliant.  I was wondering how important adopting the GS1 standards is to medical device and drug manufacturing companies.  Is this something any of you are looking at right now or have you already implemented GS1?

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