Signature of Records - Microsoft Word forms

[ErikaP - 2010]

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!

//Erika

[SteelMaiden]

When you save them, can you not save them with a name that allows you to know which record/date so you don't have to open them all to find what you are looking for? In other words, I am not sure if I understand your question/process.

[ErikaP - 2010]

Hi SteelMaiden,

some records will have a name that make me able to detect a certain record. Still, if I want to analyse several records there are no easy way to get a good overview of the data within the records. I can achieve this through an excel sheet or a data base.

[SteelMaiden]

Ah, thanks, sometimes I'm a little slow. Have you thought about a simple database? We keep moving more and more of our forms to databases, it sure is nice for searching and compiling information.

[ErikaP - 2010]

I have certainly been thinking about that and are about to migrate some FORMs to our issue tracker data base (we are a developing medical software). However, not all types of records can me merged to the issue tracker so I would need an additional database in that case.

Do you have any examples of simple databases that could be used?

[SteelMaiden]

Sorry, I do not. I wish I did, but we have application developers here that do all that stuff. I'm kinda spoiled. In past lives, I have just basically created an entry form that is pretty much identical to any Word or Excel form. Maybe someone else will read this thread and be more helpful than I have been?

[ErikaP - 2010]

Sounds good, application developer... . Perhaps I could be my own.

Thanks for your input!

[Tabitha]

I know this thread have been here for quite some time now, but I hope this will help you as well. I suggest you check out Agilewords. The application lets you share Word documents online, incite collaborators and get them to review/approve the document. Once the review is complete, the document is archived and the application keeps a complete audit trail of access and signatures.