Krishna Priya T
Starting to get Involved
Re: record retention
In FDA regulations, it is mentioned that records has to be retained till the "expected life time of the device" which is engineering calculations. the same we mentioned in our QMS manual, procedure. But if the product is working after the expected life time of the product with some servicing/changing parts, then how to mention the retention period of the records?
example:
defined expected life of the product: 5 years
in the manual/procedure mentioned that record retention is 5 years
product age in use: 6 years
in this case i've to revise the manuals and all frequently if i found that device is still in use..?
In FDA regulations, it is mentioned that records has to be retained till the "expected life time of the device" which is engineering calculations. the same we mentioned in our QMS manual, procedure. But if the product is working after the expected life time of the product with some servicing/changing parts, then how to mention the retention period of the records?
example:
defined expected life of the product: 5 years
in the manual/procedure mentioned that record retention is 5 years
product age in use: 6 years
in this case i've to revise the manuals and all frequently if i found that device is still in use..?