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Compliance Information - CFR21 Part 11


Sensory Computer Systems has invested significant time researching CFR21 Part 11.

Applies to: Clients subject to strict FDA compliance regulations, especially the validation of pharmaceutical manufacturing processes for drugs that are subject to pre-market approval requirements. Many other industry segments, such as food manufacturing, cosmetics, healthcare, etc are also frequently asking us for information regarding FDA compliance.

Sensory Computer Systems has researched CFR21 Part 11, we fully understand why it's important to you, and how other software companies such as ours is involved in the process. It's important to you, so it's important to us. We're ready for your compliance validation requirements.

This web page is our interpretation about what we discovered.


CFR21 Part 11
    Titled Topic: Electronic Records; Electronic Signatures
    Subtitle Topics: Archiving, Audit Trails, Electronic Copies, Glossary, Time Stamps, Validation

    Official FDA Link - "21 CFR Part 11 - Final Guidance for Industry", Aug 2003, 12 pages.
       http://www.fda.gov/cder/guidance/5667fnl.htm
       http://www.fda.gov/ora/compliance_ref/part11/


Interpretation
Our interpretation is that the majority of Part 11 is directed at the industrial entity submitting data to the FDA. This includes that this entity must validate all software tools used in their collecting the data, tools such as your SIMS Systems, software which must provide data auditing, data protection, and digital access rules. Sensory Computer Systems is open to discussions regarding any additional software modifications you feel are needed for your SIMS Systems to meet compliance.

For example: If your SIMS Systems is being operated as a closed system on Windows Operating systems, which is true for most of our clients, then your SIMS Systems software is already very close to compliance now, provided that the end-users also follows the procedural requirements of the predicate rule governing the laboratory in question.

Once the software is validated by the entity, then the rule-of-thumb is to not update or patch the software, or else re-validation should be required. In addition to the official web-sites, we found hundreds of discussions related to 'Software' at an active Yahoo Groups newsgroup (4000+ members, almost 16,000 posts) http://groups.yahoo.com/group/21cfrpart11/   Many discussions actually indicated that the software vendors of the entity need not be involved at all, as a matter of fact, some software vendors have been gone/defunct/dissolved while the software tools they once distributed continue to be successfully certified, by the enitity.

We also found many supplier industry statements and notations, frequently with LIMS Software Systems and Instrument Suppliers.
    http://www.particular.ie/21CFR_Compliance_Update_300401.pdf
       Source page: http://www.particular.ie/cfr21_part_11.htm


HIPAA
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a United States law that regulates the collection and handling of “protected health information” (PHI).


Final Statements
There definitely is a lot of lateral sway with the many interpretations, regarding compliance regulated clients and their software vendors. Sensory Computer Systems as a healthy and viable entity, seeking your business, may be able to assist with your compliance requirements, including entering discussions regarding Software Escrow, which seems to be the big one over all others, and discuss what other SOP documentation your site may need.


More information your SIMS Systems professional data security.

More information your SIMS Systems auditing information.