Electronic Validation Protocols (?)

[Lips]

Hi… I would like to know about your experience or opinion (I will try to explain it short) :o

It is a general question, related on how to handle validation documentation and keep compliance with requirements and auditor expectations.
In former companies were I used to work, we used to:
• keep working with validation protocols in hard copies…
• reviewed and approved prior to execution with wet-signatures.
• during execution, results were also mostly handwritten documented (e.g. in tables of results previously prepared with the plan) … also considering that some restrictions to enter with a PC in production areas was the case
• additionally, some evidence was always attached (e.g. print-screens, copies from other documents, etc) or part of the results were also added as attachment.
• Documentation was closed with a final review and approval workflow (also wet-signatures).
• As soon as all documentation was completed, a scanned copy was saved in intranet and hard copy filed in a central archive.

Now, I have the task to implement the complete process for validation activities in a company where validation-topic is something new ?.. people has not the experience and understanding yet … and as you might imagine, resistance is the first reaction.

So, now going to my question, what options do we have in case of some statements as: “I am not friend of paper documents” or “I do not want to have hard copies”.

Honestly I could negotiate, and say it will be the process… but first I want to know real options, and maybe is just me and I´m already “old-fashion”.

I know first requirements would be to have an electronic documentation management system compliant with C21_CFR_Part_11. So, let´s imagine we have it (I will evaluate it, later)… but then:

• I´m confident to say we could prepare the “validation plan” in electronic documentation system…with electronically signatures for approval. No problem at all.
• But, how to handle test executions and test records? It would be ok to transcript all data, copy and paste evidences (as print screens, copies of external docs, process printouts), give final statements of compliance by each test… all in electronic document and submit it as well for electronic approval??? I´m not sure of this point ?
• If so, at the end we will have at least two final documents, plan + results/report… and each one would require a Doc Id, right?
• Some general GDP as to sign & date all pages where results are recorded or data entered are not applicable anymore… does not matter?

As I said before, maybe I´m just some “old-fashion” and I´m not really seeing with good eyes a complete electronic solution for validation documentation? Could you tell me your experience in more modern environments?
I´m looking to hear something from you
Many thanks in advance!!!

[yodon]

I got a little lost in your questions but let me hit on a few points.

As you have multiple hardcopy documents (approved protocols, executed results), you would also have multiple documents if you managed everything electronically. The executed test results become an electronic record.

If you look at the regulation (Part 11) where they talk about signature manifestation (11.50), each signature carries specific information (signer’s name, date / time signature applied, meaning of the signature). There’s nothing in the regulation (Part 820) that would require a signature on each page; that’s just a means to try to show that the data captured on that page was recorded by the tester. You can certainly do the same with electronic signatures and thus the ‘meaning’ would be that “all the data on this page were captured by me and I attest that the results were recorded as observed” (or some such). If you transition to an electronic format, though, the concept of “pages” may not exactly apply so maybe consider test sections or test cases.

I would expect that if you did a search, you could probably find tools that would allow you to test-drive them so you can see how it all works.