Earlier today I received the following question via LinkedIn: For verification and validation test records, are signatures needed?

The person that asked the question thought the answer should be “Yes,” but is it required?

This person read through the FDA regulations (21CFR Part 820), but should could not find where it is required. The FDA regulations only require the name and date of the tester but the regulations do not state a signature is required for verification and validation testing.

There is a specific requirement for signature for process validation [i.e., 21 CFR 820.75(a)]: “The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.”

The above requirement is specific to the person approving the process validation report–not the person performing the validation activities. In 21 CFR 820.30(f) (i.e., design verification), and 21 CFR 820.30(g) (i.e., design validation), there is also a requirement to identify the person performing design verification and validation activities, but the verification and validation reports should be approved with a signature–although this is not specifically stated in the regulation.

You could make an argument that the person performing the work should sign any data collection forms to verify authenticity of the results, but this is the responsibility of the person reviewing and approving the verification and validation reports. Therefore, an employee number, initials or just the printed name of the person performing the work is sufficient. Inspectors and auditors may verify that the person performing the activities was qualified and request documentation of how the person was selected or trained, but the person’s signature is not required.

Signatures are also required for the person performing final product release under 21 CFR 820.80(d)(3) and 21 CFR 820.80(e)(4) (i.e., acceptance activities). The FDA regulations state only the name of who reviewed the testing results and released the product. This is often performed by an administrative person that will review multiple tests from raw material inspection, in-process inspections, final inspections and even sterility testing results just to make sure that all the paperwork for a Device History Record (DHR) is complete and that all tests were passed.

If your records are 100% digital, and your company has a lab information management system (LIMS), inspectors and people performing verification or validation testing may be required to login to the LIMS system with a unique user ID and password. Then the calibration ID of the device used for measurement may need to be entered before any measurements can be taken. Finally, after each measurement the person may press a button to upload the results to a database so that 100% of inspection results are recorded in the DHR and the identity of the person performing the measurements is documented.

I have observed forms that have a place for a signature or a procedure that states a signature is required. If your company has a form or procedure that requires signatures, then you will also need to comply with internal policies–even if the FDA doesn’t require a signature. Often FDA Form 483 inspection observations and auditor findings are specific to internal policies rather than actual nonconformities with regulations.

source: https://www.linkedin.com/groups/2070960/2070960-6186275451233660932