Employee Signature List for Medical Device Company

[Lesley1707]

Hi, I am new to the forum and have found all the threads extremely informative and enlightening. Thank you.

I am looking for advice on employee signature lists. I work in a small medical device company that design, develop and manufacture in vitro diagnostics and we are working towards ISO 13485 certification and abiding by 21 CFR 820 regs. We have approximately 30 employees across 2 sites and I seek clarification as to whether our admin department should be included in this list.

L

 

[GStough]

Hi, I am new to the forum and have found all the threads extremely informative and enlightening. Thank you.

I am looking for advice on employee signature lists. I work in a small medical device company that design, develop and manufacture in vitro diagnostics and we are working towards ISO 13485 certification and abiding by 21 CFR 820 regs. We have approximately 30 employees across 2 sites and I seek clarification as to whether our admin department should be included in this list.

L

Hi and welcome to the Cove!

What would this list of employee signatures be used for? I'm thinking perhaps you mean for the purpose of controlled document approval with an eye towards electronic signatures at some point in the future?

In a previous life as document control specialist, maintaining a list of approving signature authorities was something I did to keep us out of a bind whenever the major approver was out of the office. Each approving authority had 2 alternates whom they trusted to approve documents in their absence. For each approving authority, I maintained a sheet with their signature, stating that they authorized so and so and so and so to act as their designated alternates in their absence. The approver signed the sheet and each of their alternates signed it, as well.

These forms were updated every 6 or 12 months, and more than once got us out of a pinch when something needed to be revised in a hurry and approval was necessary.

Sorry to be so long-winded, but I hope this helps a little.

 

[GStough]

Oh, and if the admin department has controlled documents, then yes, I would include them, as well.

 

[arios]

Consider also including in your signature's matrix the employee's initials besides to the signature. I know there is not a prescribed requirement for this but you may do it as a good practice as not always the employees use their printed name and signature but also initials on small spaces as evidence of approval or awareness. This way you have a better way to demonstrate people's identity in records.

 

[ScottK]

Hi

when I worked for a drug and device packager we kept a list of employee signatures and initials based on a recommendation from a couple of our larger customers. The reason was that it made it quick to identify an illegible scrawl of a past employee if need be.

We only kept this file for people signing off on quality records.
So admin was excluded unless they substituted for people signing quality records on occasion.

 

[pkost]

I find that the best way to deal with illegible signatures is to ensure that people print their name in caps next to the signature and date; on occasion also their role. This gets around the whole problem of not knowing who signed.

 

[MIREGMGR]

Our HR Department is tasked in the Document Control procedure with maintaining a log of every employee's signature and initials, in conjunction with that individual's secure personnel file. All of our high level approval processes involve specific individuals and their alternates, but many of our production processes require that individual employees sign off as having completed their individual task. We're more comfortable having the entire employee base encompassed by that aspect of the quality system.

 

[Lesley1707]

Thanks guys for all the responses.

Initials are included on the sheet and we have a separate document for approvers / delegates of docs etc. I just thought that as we are such a small company that the admin staff should be included on the list as they deal with purchase and sales orders which, when completed, I would regard as a record. These items are signed off and filed once complete.

I shall readdress the list!

L

 

[v9991]

The key is to verify, whether Admin is part of any activities related to Quality!

Primarily, they are entrusted with the responsibility of maintaining the personnel records...further the annual health checkup is one of the activity entrusted with Admin department hence falls in the purview of quality records; So, signatures of the people who are implementing&reviewing that procedure have to be maintained.

hope that helps.