How is documentation affected moving to an electronic system?

NikkiQSM

Quite Involved in Discussions
Two poins:
The standard doesnt ask to keep the old version.
It needs control of changes.
Dont you think is it sufficient to show the description of the change described in the document? And also signatures of reviewers and approvers?
Other point, I worked in an engineering company that, avoided the manage of obsolet documents, because when engineers used by mistake obsolet documents, caused very costly errors, e.g. instead of using drawings rel 6, used rel 4.

I understand the standard doesn't tell me to keep the old revisions - but why would I be asked to show them so many times during audits? I have a log that shows that they have been updated and what has changed - but they still ask for them.
 

Al Rosen

Leader
Super Moderator
I understand the standard doesn't tell me to keep the old revisions - but why would I be asked to show them so many times during audits? I have a log that shows that they have been updated and what has changed - but they still ask for them.
What standard are you referring to? ISO13485 requires retaining a copy of the obsolete documentation for the lifetime of the device, and at least two years for records.
 

Golfman25

Trusted Information Resource
A report should be able to produce a copy of the previous revision(s). Once a document is committed a record is made in the database. It doesn't take much space in a database file. The revision should create a new record which is linked to the previous record (and so on).

If the database wasn't designed this way, well - Even cheap software does this. Like I say, even with vBulletin (and most forum software, if not all, which are based on a relational database) saves a copy unless an admin specifically tells the software to "permanently" delete a record. So, if a post in a thread here is edited 50 times there will be 50 corresponding complete records, all linked by date, and with information such as who did the edit, the time and date, the IP they were on when they edited, and some other info.

I can't speak to custom written software other than some experiences in years past, a few of which came off very good, and a couple which ended up as near disasters. The disasters were mainly due to the company not properly specifying their requirements.

Caution - Old Man Rant: I used to write relational databases some years ago with Foxbase, Filemaker, and a few in Microsoft's Access. Common practice, even back then, was you have a form. As soon as the form is "committed" (saved) a database record is created. When the form is brought up again, it is completed and when committed makes a new entry in the database. The original (and past records) are not deleted unless a special "query" is run (often called a "prune"), which can be specified, for example, delete everything prior to <date> (for example).

I think there is a difference between a running "what's new" log of changes and revisions and being able to recreate an old version. If my software creates a PO that I can print out and that report is revised to include additional information, I may not be able to reproduce that old PO from the system. I might have "old copies" of completed POs filed away somewhere.
 

Marc

Fully vaccinated are you?
Leader
I think there is a difference between a running "what's new" log of changes and revisions and being able to recreate an old version. If my software creates a PO that I can print out and that report is revised to include additional information, I may not be able to reproduce that old PO from the system. I might have "old copies" of completed POs filed away somewhere.
Different companies, different philosophies, different requirements. To me it's a "risk assessment" in that if there is ever a question I have a solid reference. But, you're right in that if you see no need and there is no requirement, no reason to keep copies of revised documents. I'm just a biologist who ended up in business and starting in DoD work it was drilled into me to always kept a copy of every successive document. The practice has saved my :ca: many times over the years.

I understand the standard doesn't tell me to keep the old revisions - but why would I be asked to show them so many times during audits? I have a log that shows that they have been updated and what has changed - but they still ask for them.
Have you ever simply said "where does it say that I am required to keep copies of the previous document(s)?" This type of thing with auditors goes back years - there have long been discussions of auditors asking for things that aren't required. I can't say why auditors do this, but it's very common and is a common complaint. That is why "Show me the requirement" has been a common response to auditors for many years.
 
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