Home | Is Your Labeling System Really 21 CFR Part 11 Compliant


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.

Through our research & development of software we’ve found five main areas that often fall short when being audited. These are all common issues that are brought to our attention time and time again:

  1. The labeling software is non-compliant to 21 CFR Part 11 and is not supported by validation documentation
  2. The labeling software is non-compliant to the requirements detailed in quality systems regulation 21 CFR Part 820
  3. The labeling SOPs are not documented
  4. There is no label batch traceability or direct employee accountability in the event of a product recall due to labeling
  5. The labeling system does not meet the needs of the FDA in terms of version control and history for each label design.

Using properly validated systems is the obvious answer to solving your compliance issues but it’s worth asking yourself the following questions which will guide you in the right direction:

  1. Is the labeling software you are using “fit for purpose” for Life Sciences labeling requirements, specifically 21 CFR Part 11?
  2. In the event of a product recall or FDA audit, are you able to supply an audit log of the label history going back 5 years and can you provide this to an auditor in a reasonable amount of time?
  3. Is your labeling software supported by full lifecycle documentation to prove your exact needs were considered before it was purchased?
  4. Did your software get installed as part of a validation exercise covering all labeling printing terminals and printers?
  5. Can you be sure compliance of the labeling system has been proven over its network or web connection?

If you have any questions please send us an email or leave a comment below.

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This entry was posted on Friday, November 7th, 2008 at 11:07 AM and is filed under FDA, Labeling Regulations. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

One Response to “Is Your Labeling System Really 21 CFR Part 11 Compliant”

  1. Bob Tilling says:
    December 15, 2008 at 9:23 AM

    Labelling is one of the top areas companies fail an FDA audit. As a consultant on FDA 21 CFR Part 11 compliance I have dealt with this exact scenario many times. Your presentation reflects my own experience of the most common areas for failure within the labelling process.

    In my opinion custom in-house designed labelling solutions based on general labelling software present a far higher compliance risk to Life Science companies compared to using purpose designed FDA Compliant labelling software

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