Validation of Quality System Tools

[singber]

Hello,
Can anyone point me in the direction of any FDA guidance/documentation regarding the validation of tools that support the quality system? Such tools would include:
-A learning management system that stores training records.
-A document control system that creates and stores processes as required by 21 CFR 820.40

Trying to determine the amount of validation and the extent of validation documentation that is required.

Thanks!

 

[Statistical Steven]

21CFR11 aka Part 11 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11)

Try that for a starter!

 

[yodon]

Keep in mind that the extent of validation should be commensurate with the risk. Do a risk assessment to determine the impact if you lose records those systems manage. That will drive the 'amount' of validation needed.

 

[Roberticus]

While Part 11, as attached above, is certainly important, particularly if your company does any type of electronic signatures, this item, elsewhere within Elsmar some time ago, can be especially helpful with validation of software which is not a device or component of a device, but instead part of the quality system. Section 6 of the attached deals with how users must apply the validation of off-the-shelf software to their specific Defined User Requirements, and also how risk mitigation in terms of related verification activities can help prescribe the scope of how much validation is required to ensure that the software "will perform as intended in the [your Company's] chosen application." Also, if you have any experience with IQ/OQ/PQ, you should consider framing validation in this format.

 

[Statistical Steven]

While Part 11, as attached above, is certainly important, particularly if your company does any type of electronic signatures, this item, elsewhere within Elsmar some time ago, can be especially helpful with validation of software which is not a device or component of a device, but instead part of the quality system. Section 6 of the attached deals with how users must apply the validation of off-the-shelf software to their specific Defined User Requirements, and also how risk mitigation in terms of related verification activities can help prescribe the scope of how much validation is required to ensure that the software "will perform as intended in the [your Company's] chosen application." Also, if you have any experience with IQ/OQ/PQ, you should consider framing validation in this format.

If your QMS is based on 13485 or 21CFR820 then any computer system that is used should follow the principles of Part 11 or cGAMP 5.