Do you think old documents such as training binders, raw material documents(i.g., material release checklist) can be disposed if it is scanned and will be a “true copy” ?
I can’t google any guideline saying specific retention period for these types of document.
Retain all the documents related to raw materials receipt & issuance to production upto, final product expiry +1 year.After that you can destroy.
Training records should be maintained life time …
Thank you for replying. And I have additional question. Do we need to maintain retiree’s training binder? I think it can be destroyed since retiree’s record don’t have impact.
mostly all documents must be stored for a minimum of 5 years. Training records are kept more than 5 yrs if the personnel is still working in your company until he resigns or retire.
You have to keep even the Employee has resign from the Organization, my he will come back to the employer with 21 CFR or any health care issues, even before leaving of the employee from the organization shall perform medical check up to confirm his fitness before leaving
Before destruction documents are scanned and kept as electronic records are training records to be scanned as well?
you have to be able to prove that anyone who worked on a batch was trained at time of production. Training records need to be kept AT LEAST AS LONG as the retention period as the batch records the operators were involved in (usually one year after end-of shelflife). That includes the ones who have already left your company. Either as hard copy or scanned.
Thank you sir.very clear answer.