Wanted to get input on having employee signature forms on file for all employees. I work for a very small (<25), virtual startup company. In my past (larger commercial pharma), we required employee signature forms for all employees. Is there a specific requirement that you can point me to? Is this needed for a virtual company? Any help would be appreciated! Thank you!
I do have experience with signature forms. Generally, if you have “signature authority” for purchases, authorizations, log and tag precautions, then the employer does like to have a signature (and initials) on record so if they have a form they need to research - who signed this??? then they can look up the signature. I literally signed hundreds of items a day when I was a Navy Officer (mostly tagouts in repair periods), so they needed this on record. I would assume big Pharma has folks with signature authority.
I can't say if there is a “requirement” per se - but you need to ask - do we have employees signing things where the ‘printed name’ is not present - and will we foreseeably have a need to figure out who's signature that was? I suppose as things go more toward electronic approvals, signatures may go away. Also, at one location the QA inspectors had serialized stamps for approval of hold points, also eliminating the need for deciphering signatures.
Not an expert here. However, I do know that in pharma companies a signature register is maintained having a master signature (and initials) for each employee who is authorized to release product. I would guess the register also includes personnel who document/sign off on other critical activities, and may simply include all employees since personnel may move jobs. However, there needs to be a link between the signature authority and training/qualifications.
Do not know which CFR is applicable.
My recommendation is to use stamps. For aerospace military and commercial aircraft we use stamps and a date next to the stamp impression. Signature can be forged.
We have an initial form as every correction and each note page needs to be dated and initialed. I asked certain units to provide me with their signatures as I couldn't read their signature scrawls on the paperwork they submitted to me. Do you have the need to know the identity of an unreadable signature in the future if that person is no longer at the company and no one remembers what their signature looked like?
If this is a virtual company, are signatures going to be electronic? I work for a mid-sized pharma/manufacturing company and we are starting to implement electronic signatures using Microsoft Outlook and Adobe. Together, they have verifiable signatures using the individuals email.
I hope this helps. It's a very good tracking device.
Eudralex Volume 4 Chapter 4 “Documentation” requirement 4.29 “There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:”, bullet 5 “Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training. ”
PIC/S Guidance on Data Integrity requirement 8.6.1 expectation 4 “Check that there are signature and initials logs, that are controlled and current and that demonstrate the use of unique examples, not just standardized printed letters.”
I think there is some OECD GLP Document that has firm signature requirements I can check if you need a non-GMP regulatory requirement.
In aerospace industry particularly in aircraft maintenance/engineering, every certifying staff is issued with stamp controlled by Quality dept along with signature specimen records. Thus, every stamp number is traceable to a person. While using stamp alone is acceptable, some organisation who experienced misuse of stamp (after it lost or misplaced), require both stamp and signature affix on the paperworks.