Hi,

As of now we are using ERP, PLC, power checking for intraocular lenses, label printing softwares etc., We would like to implement software validation procedure as per FDA requirement. Kindly help me.

Usually software validation are done while installation. Is re-validation required as per schedule like once in six months or once in a year? Else we can re-validate only if there is any change in software. Kindly advice.

Regards
Usha

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085371.pdf

Read this FDA guidance document for starters. you are refering to Quality systems software; section 6. Good luck. Rich

Hi,

As of now we are using ERP, PLC, power checking for intraocular lenses, label printing softwares etc., We would like to implement software validation procedure as per FDA requirement. Kindly help me.

Usually software validation are done while installation. Is re-validation required as per schedule like once in six months or once in a year? Else we can re-validate only if there is any change in software. Kindly advice.

Regards
Usha
In addition to time-frame revalidation requirements your procedure should definitively require revalidation whenever there is a significant change.

Hi
Once an item/program/system is validated it must be maintained in the validated status and as long as is maintained in accordance with GMP practices and procedures, then, revalidation is not mandatory.

If you have already produced regulated product using your new software then you should immediately instigate a retrospective validation program.

Alex Kennedy