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How is documentation affected moving to an electronic system?

NikkiQSM

Quite Involved in Discussions
#1
We are transitioning from paper based to an ERP system.

Our controlled documents are being implemented into the system but they will appear as fields, rather an documents. They will all have change history recorded and revision levels.

In the past, I was required to keep the old revisions of our documents. I have been asked many times by auditors for them.

How will that work with an ERP system?
We will still have a log of the changes - but am I required to save a screen shot of what it looked like before the change?

thanks in advance,
Nikki
 
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Al Rosen

Staff member
Super Moderator
#2
The answer is from ISO13485:2016

4.2.4
:
:
h) prevent the unintended use of obsolete documents and apply suitable identification to them.

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function that has access to pertinent background
information upon which to base its decisions.

The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufacturedand tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements.
 

Golfman25

Trusted Information Resource
#3
I am not a med guy, but from the sound of it a screen shot before the change or a printout of the old data/form may be required.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Our controlled documents are being implemented into the system but they will appear as fields, rather an documents. They will all have change history recorded and revision levels.

In the past, I was required to keep the old revisions of our documents. I have been asked many times by auditors for them.

How will that work with an ERP system?
The people who sold you the software should have provided this information prior to purchase, as it is such a basic need.

Most ERP software keeps a history of revisions, not just revision dates. They're just databases, after all. Even here- If a post is edited, for example, a log entry is made and a copy of the post prior to the revision is kept. You can even call for a screen which will display both in side-by-side windows and show both new additions, as well as anything that is deleted. Your ERP software may not have this "compare" feature, but it should keep a copy of each revision so worst case is to print out a copy of the prior revision if an auditor asks. Usually if an auditor asks and you show that you can do this they'll let it go and move on.

What ERP software are you using?
 

NikkiQSM

Quite Involved in Discussions
#5
The people who sold you the software should have provided this information prior to purchase, as it is such a basic need.

Most ERP software keeps a history of revisions, not just revision dates. They're just databases, after all. Even here- If a post is edited, for example, a log entry is made and a copy of the post prior to the revision is kept. You can even call for a screen which will display both in side-by-side windows and show both new additions, as well as anything that is deleted. Your ERP software may not have this "compare" feature, but it should keep a copy of each revision so worst case is to print out a copy of the prior revision if an auditor asks. Usually if an auditor asks and you show that you can do this they'll let it go and move on.

What ERP software are you using?
It's custom made for us. We are about to launch the validation portion of it. Our IT guy is checking into this query for me but it sounds like we will only have a simple log to look back on - but how the screen actually was set up before the change.
 

Golfman25

Trusted Information Resource
#6
The people who sold you the software should have provided this information prior to purchase, as it is such a basic need.

Most ERP software keeps a history of revisions, not just revision dates. They're just databases, after all. Even here- If a post is edited, for example, a log entry is made and a copy of the post prior to the revision is kept. You can even call for a screen which will display both in side-by-side windows and show both new additions, as well as anything that is deleted. Your ERP software may not have this "compare" feature, but it should keep a copy of each revision so worst case is to print out a copy of the prior revision if an auditor asks. Usually if an auditor asks and you show that you can do this they'll let it go and move on.

What ERP software are you using?
I don't know about this. In my experience, once you update the software the old version is "gone forever." Now I am not convinced that it is a "big deal." Most ERP screens are for data entry and presentation. You can then print a "report" if you need paper. Seems to me the real concern is the integrity of the data. Too complicated for my pay grade.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
Pancho has written about Wiki software (free) here.

If your software doesn't maintain a change record of all changes your company didn't adequately spec out what the software must do. It is a basic function. Pretty sad.
 
#8
We are transitioning from paper based to an ERP system.

Our controlled documents are being implemented into the system but they will appear as fields, rather an documents. They will all have change history recorded and revision levels.

In the past, I was required to keep the old revisions of our documents. I have been asked many times by auditors for them.

How will that work with an ERP system?
We will still have a log of the changes - but am I required to save a screen shot of what it looked like before the change?

thanks in advance,
Nikki
In my experience, Nikki, ERP systems make things more complicated, because the software people don't understand ISO 9001 requirements. Having said that, some are better than others. All have their challenges. I'd scan the changes and upload them into a folder.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
I don't know about this. In my experience, once you update the software the old version is "gone forever." Now I am not convinced that it is a "big deal." Most ERP screens are for data entry and presentation. You can then print a "report" if you need paper. Seems to me the real concern is the integrity of the data. Too complicated for my pay grade.
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).
 

qualprod

Trusted Information Resource
#10
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.
 
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