Electronic records

Does anyone know of any good guidance or other relevant informtion which would help make the decision about whether an electronic item is an electronic record (as per 21 CFR Part 11) or not?

I can think of numerous examples of what might be debateable, and would like to produce some clear internal guidelines for personnel to help them decide either “yes - this is an electronic record” or “no - this isn’t” or “more information / debate is needed”.

Any and all help would be welcome.

Thanks

Would it be possible to give an example of this record

Some examples are:

A recipe in a PLC consisting of a set of variable values - my own view is that this isn’t an electronic record - but I’m not sure

A spreadsheet set up to record values collected during a PQ, where the values are input, and a cell uses an “if” formula to display whether the result is a pass or fail - the spreadsheet is printed out and signed - I think this isn’t - but am not sure

A spreadsheet set up to be emailed around a group of people to collect information - when completed, the data will be transcribed into a (validated) system to form a bill of material. The spreadsheet will be held on the company shared network drive and re-sent when information changes or needs updating.

And so on! I think I’m right (!) but am never sure.

Thanks

[quote=Cat]Some examples are:

A recipe in a PLC consisting of a set of variable values - my own view is that this isn’t an electronic record - but I’m not sure[/quote]

I agree this isn’t an electronic record, these are configurable values

I would do some kind of test to show that the if statement is working correctly. as you have a paper copy which is reviewed and signed this is your primary copy - so electronic record does not apply here

Look at this this way it is equivalent to someone inputting data into a validated system. Dont see a problem here either[/quote]

Hi Cat
The FDA have spelt out a very simple and easy format to decide whether you have records that requires to be protected by 21 CFR Part 11, or not. If you ask the following four questions of your records and receive four answer of ‘NO’, then part 11 is not mandatory.
………………………………
Does the system comprise of records or signatures (such as data, reports? Etc.) That are required by FDA regulations, (E.g. GxP’s Financial Disclosures by Clinical Investigators)?

Does the system comprise of records or signatures that are not required by the FDA regulations, but are included in electronic submissions to the FDA?

Does the system generate signatures that are not required by FDA regulations, to required regulatory records?

Does the system comprise of electronic records as described in 1 & 2 above that were created before August 29th 1997 and are maintained and accessible for deletion and modification?
…………………………………………
The above is enshrined in law. The rhetoric that was rife for several years was not, and that is what this ‘pause for thought’, with Part 11 is all about.

Does an SOP have to be Part 11 compliant?
Well, an SOP is usually an instruction, and clearly when the four questions above are applied to it - Part 11 does not apply.
However many SOP’s require signatures to verify that the instructions they contain, have been carried out. Now we find if we apply the four question to the SOP completion sheet, the answer may have changed, and Part 11 will apply if the records produced, have been produced electronically.

The greatest majority of SOP’s are executed from a paper document and the signatures are collected on a paper document, and part 11 does not apply.
In the instances where the data is produced and stored electronically, then Part 11 will apply, unless the data is downloaded while it is classified as raw data. That is before it is stored as editable data.

The security with SOP’s come from the documented methods of storing, editing and the controls put on access, that are all rigorously enforced.

If this philosophy is followed through, it is reasonably easy to classify what document requires Part 11 protection (mandatory) and what document will suffice with procedural protection. Of course there is nothing stopping you applying Part 11, to all documents.

The FDA has stated, that it expects each company to have a written justification, as to whether Part 11 applies to documents or not. Documents that Part 11 has not been applied to must be subjected to stringent security controls, to protect content from inadvertent or even deliberate alteration. They must be managed to ensure they are always current.

Alex Kennedy

[quote=Cat]Does anyone know of any good guidance or other relevant informtion which would help make the decision about whether an electronic item is an electronic record (as per 21 CFR Part 11) or not?

I can think of numerous examples of what might be debateable, and would like to produce some clear internal guidelines for personnel to help them decide either “yes - this is an electronic record” or “no - this isn’t” or “more information / debate is needed”.

Any and all help would be welcome.

Thanks[/quote]

Yes there is a lot of difference between electronic and electronic record . the device which you use to producce data is electronic and the report which you generate through the data is electronic record. you can retain ,store ,retrive,delete, etc electronic record at any time