Hi I’m from Mexico, but I would like to know where, in the US laws, says that the software has to be validated. I know that FDA has guidances for software validation but, I think they are not the law.
I will apreciate a lot if sombody can help me.
Thanks in advanced.
You’re right in that guidance is not law. The law is the Quality Systems Regulation (QSR) 21 CFR 820 (
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820
) for medical devices. It’s different if you’re subject to pharma laws.
If you’re talking about product software, validation is required by:
820.30(g)Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
If you’re talking about validating software used in the manufacturing process, it’s part of:
820.70(i)Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.
Hope that helps!
Yes, this is what I’m loocking for!!
Thankyou very much!!
Additionally, if the software is used for the storage of electronic records used to fulfill other predicate requirements then 21 CFR 11.10(a):
“Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”