Signature of Records - Microsoft Word forms
I´m aiming to improve our process for quality records (we are following ISO 13485). Until now we have mainly used the following approach:
FORM in Word -> Filled in FORM in Word -> FORM signed by author or other authorized person through an electronic signature -> FORM transfered to PDF and saved at the approperiate place within our electronic system.
The drawbacks with this approach are:
1. It is not straight forward to get an overview of all records of a certain type (all pdf.s must be opened and examined).
2. The manual steps are several and employees hesitate to fill in records (too complicated).
These are my thoughts:
1. Transfer WORD FORMs to issues/tasks as a part of our issue handling system. This allows an automatic workflow from initiation until final approval/verification of the record. When the issue/task has been closed by the approperiate person, the record are considered complete and maintained.
2. Transfer WORD FORMs to Excel sheets where several records can be stored in the same document.
While looking at this approach I realise that I have a lack of understanding of the purpose of signatures within records. What are the requirements regarding signatures/initials on quality records? Are there any difference between an electronic signature in Word and an issue closed by a specific user in a software system?
I assume that all records include shall include the name or identity of the person making the entry to allow for identification? Would an entry by filling in a name in an excel file be sufficient (as this in theory can be easily done by anyone not only the person in question - protection).
If an excel file includes several entries performed by several persons, how can I assure that previous entries are protected as new entries are done? Will a "record owner" be needed to sign the record every time a new entry is filled in?
Thanks everyone for a great forum!
Last edited by ErikaP - 2010; 4th May 2010 at 04:24 AM.