Control of Records

DarisS

Starting to get Involved
#1
Hello,
That topic is pretty old, but I can not find an answer on other post regarding the question "is an Excel file a Record?"
In fact, Excel file can be modified, means you can modify your records. And printing, signing and scanning an Excel file has no added value other than just demonstrating the integrity of your record. I also have seen companies saving the excel page under a pdf file to keep data integrity, but pdf can also be modified.
What would be the good practice on using Excel as a record means?

Thanks
 
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Jean_B

Trusted Information Resource
#2
There are no living documents.
Such documents are either:
  • Lists with a record in each (exceL) row (in essence a database), which is inadequately controlled versus the ALCOA+ data integrity principles.
  • Summary overview of such lists, where a record pertaining to the same thing (key-ID) is overwritten when new information arives(even worse, because you're actively destroying information).
    • Sometimes people say they'll upload a snapshot of it to an actual document control system regularly/intermittently,
      • which invariably fails to happen often enough to prevent loss of any intermediate changes,
      • and likely eventually won't be updated at all.
    • No, backups do not count (though they do soften the ire of a serious doc-controller, because your ability to retrieve more information improved).
  • Actual documents, but with either an annoyingly large amount of people who would want to sign/should sign, or with some unscrupulous aspects which people would rather not have show up in the listing of documents within a document control system.
Solutions:
  • For collections of records use the correct tool: a (properly secured) database
  • For summary overviews: pivot the information in the database to the information you need
  • For documents: have high level people own the architecture in a high level document(ed procedure), and cut up the detail over multiple (work instruction) documents based on a manageable (ha) amount of people involved; and stop doing the unscrupulous stuff which you shouldn't have begun anyway.
 

Casana

Blueberry Nut
#3
This answer is still relevant:

What does your documented procedure for control of documents say?

You design your system in a fashion to retain documented information of compliance. If you choose to call some documents "live" and some "records", that is your call to make.
Also keep in mind that
- the standard does not make a distinction between control of documents and control of records anymore.
- it just requires that documents be identified properly and protected (to maintain integrity, confidentiality, etc).
- more details in 7.5.2 & 7.5.3 in ISO 9001.
 

malasuerte

Quite Involved in Discussions
#4
Hello,
That topic is pretty old, but I can not find an answer on other post regarding the question "is an Excel file a Record?"
In fact, Excel file can be modified, means you can modify your records. And printing, signing and scanning an Excel file has no added value other than just demonstrating the integrity of your record. I also have seen companies saving the excel page under a pdf file to keep data integrity, but pdf can also be modified.
What would be the good practice on using Excel as a record means?

Thanks
To answer your specific question: Put a lock on the Excel so it cannot be edited; then put it on a share drive, sharepoint, etc.
 

DarisS

Starting to get Involved
#5
This answer is still relevant:

Also keep in mind that
- the standard does not make a distinction between control of documents and control of records anymore.
- it just requires that documents be identified properly and protected (to maintain integrity, confidentiality, etc).
- more details in 7.5.2 & 7.5.3 in ISO 9001.
Hello, Thanks for the feedback.
I forgot to mention that I'm working on an ISO 13485 certified company. There is still a specific chapter (4.2.5) on control of records.
The area where I'm unconfortable is with the sentence " Changes to a record shall remain identifiable." and "protected to maintain integrity". An Excel file can be modified and there is not that much you can do about it as long as your Excel file is used both for daily inputs and information sharing and also as your record log containing all the evidence of the work done. In my case, we are talking about NC and CAPA follow up.
On the previous answer Jean_B mentionned "the correct tool", but it would require more ressources to get and maintain such specific tool.
It has to be noted that no one (registrar or customers) never complained about that situation.
 

malasuerte

Quite Involved in Discussions
#6
Hello, Thanks for the feedback.
I forgot to mention that I'm working on an ISO 13485 certified company. There is still a specific chapter (4.2.5) on control of records.
The area where I'm unconfortable is with the sentence " Changes to a record shall remain identifiable." and "protected to maintain integrity". An Excel file can be modified and there is not that much you can do about it as long as your Excel file is used both for daily inputs and information sharing and also as your record log containing all the evidence of the work done. In my case, we are talking about NC and CAPA follow up.
On the previous answer Jean_B mentionned "the correct tool", but it would require more ressources to get and maintain such specific tool.
It has to be noted that no one (registrar or customers) never complained about that situation.
Certainly, you can do something about changes in Excel - you can track changes of who and when they were done. So if someone either inadvertently or purposefully changes a part item/line/field, you can see the change and go follow up.

If this is not acceptable, then you need to do something like lock the sheet daily; and use a new sheet for the next day.

FYI - this is not about registrar or customer "complaining"! This is about the requirement for records that an organization should adhere to. Plus, You should always strive to do the right thing. Also, Be Proactive/Preventive - -- I don't want a customer complaint. Additionally, what happens if there is an issue and some regulatory agency comes looking for the records?? I'd be concerned with that too.
 

Enghabashy

Quite Involved in Discussions
#7
the records of the organization are one type of documents & information ; when I fill , dated & signed any document ' it transfer to quality record also & should be maintain & controlling of failing and comply with other requirements of standard ; record is one evidence of effective implementation of management system ; let's to give example : * there's standard contract & standard invoice the issued from governmental authority; this is regulation should be followed by organizations, it's regulatory document , --- when I use the contract & invoice to fill , sign & dated , its' still kept & distributed as document & fillng and controlled as Document & record control , the records could be multi generated from the main one document
 

dwperron

Trusted Information Resource
#8
Hello, Thanks for the feedback.
I forgot to mention that I'm working on an ISO 13485 certified company. There is still a specific chapter (4.2.5) on control of records.
The area where I'm unconfortable is with the sentence " Changes to a record shall remain identifiable." and "protected to maintain integrity". An Excel file can be modified and there is not that much you can do about it as long as your Excel file is used both for daily inputs and information sharing and also as your record log containing all the evidence of the work done. In my case, we are talking about NC and CAPA follow up.
On the previous answer Jean_B mentionned "the correct tool", but it would require more ressources to get and maintain such specific tool.
It has to be noted that no one (registrar or customers) never complained about that situation.

In your case, wouldn't it make sense to save the file, locked and read only, in a secure folder, after every time you update it? You would then have individual, secure, time stamped records to present. You can highlight the changes as you make them to make analysis easier.
 
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