21 CFR 820 Record Control Requirements

M

MIREGMGR

#11
Note however that there's a valid question, not substantively answered yet by the FDA as far as I know (and I've asked them directly), as to whether some form of electronic capture or recording of a signed document in a 21CFR Part 11 context may become a valid record in and of itself, including a record of the signature, sufficient to replace the original document for regulatory purposes so that it would be permissible to destroy the original document.

That for instance might consist of a record-batch scanning or photographing procedure, with a signature per batch by the scanning individual indicating that they had performed the scanning and that the records they had scanned were original, apparently unmodified and were physically signed and dated.

We've been told that such a process isn't acceptable at this time, but that it's being considered.

Such a process of course would be substantially different from transcription of data into a spreadsheet, which inherently does not capture the signature involved or allow any inspection of the nature of the data record.
 
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M

Mark75

#12
Thanks for all the input pertaining to this topic. Sometimes the regs are not very specific, and I think they were probably written this way so that each company can has some flexibility to define for themselves the best way to go about meeting the basic requirements. However, this can lead to many different interpretations and this is why I also try to refer to guideance documents as well as 483s and warning letters by the FDA to help understand the interpretation from the FDA's point of view.

My point of view has been that data related to the process that has been determined to be a required part of the DHR must be defined (established) and maintained to demonstrate that the device is mfg'rd in accordance w/ the DMR and the req's of section 820.184. In order to define and maintain the data that must be captured you have to control the records (forms, notebooks, etc) via a change control process (820.40), or other controls when notebooks are concerned. 820.184(d) also makes reference to established acceptance records as part of the DHR. According to 820.80 (Acceptance Activities), section 820.80(e) specifically states that acceptance activities will be documented and the records will include information such as the signature and date of the individual(s) conducting the acceptance activities <820.80(e)(4)>, and also states these records will be part of the DHR <820.80(e)(5)>. Section 820.70(a) also states that each manufacturer shall develop, conduct, "control", and monitor production processes, which includes monitoring and control of process parameters. To "control" the methods for monitoring, this brings me back to 820.40.

I could maybe buy-off on justification that a controlled procedure defines what type of information must be collected when non-controlled methods for collecting data are used (w/ the exception of using sticky notes). However, I would still recommend establishing controlled records as attachments to this procedure as an opportunity for improvement. I don't see any way around not maintaining the original, signed and dated records as part of the DHR.
 

jkuil

Quite Involved in Discussions
#13
Subpart M of 21 CFR part 820 deals with records
  • In 820.180 General requirements: "and shal be stored to minimize deterioration and to prevent loss" Is essence you have lost your source documents and can not provide full traceability of data
  • In 820.180b "All records required by this part shall be retained..."
  • Section 820.184 specifies the records you generate per batch, lot or unit of products. Your laboratory may fall under this category
  • If they are not product specific they are quality system records as specified under 820.186
 
M

maxenix

#14
IMO, these violations include, but are not limited to, the following:

1 Failure to establish and maintain adequate DMR (b) Production process specifications ncluding the appropriate equipment specifications, production methods, production procedures, and production environment specifications,as required by 21 CFR 820.100. For example:
a. The blank forms for recording the data are not a part of DMR since you do not have such controlled form.(SEE QS MUANL:12 PRODUCT EVALUATION)

2 Failure to ensure that the QSR is prepared and approved in accordance with § 820.40 required by 21 CFR 820.186. For example:

a. The blank forms for recording the Lab test results ( process parameter checks & Quantities of product produced & scrapped )are not prepared and approved in accordance with 21 CFR 820.40.

3 Failure to conduct, control, and monitor production processes to ensure that a device conforms to its specifications as required by 21CFR 820.70, For example:

a. You can't supply original records of Lab test results and so on since those records are thrown away. (FDA think:if it is not written down, it never happened, only a transfer done (from paper to electronics)).

4 Failure to ensure the authenticity, integrity of the electronic records requied by 21 CFR PRAT 11.30.For example:
a. Do not transfer records in a authenticity and integrity way as what you says.
 
Y

yeshpal

#15
Aren't they meeting that requirement by noting the data on a "scratch pad" and then entering it into excel?

Hi Al Rosen,

"Scratch Pad" (source document) should be maintained (retention-Archival) for compliance, Quality and Regulatory revival etc...; if it were to be under Regulatory compliance.

My Perception,:cool:

Thanks & Regards,
Yeshpal Mathangi
 

Al Rosen

Staff member
Super Moderator
#16
Hi Al Rosen,

"Scratch Pad" (source document) should be maintained (retention-Archival) for compliance, Quality and Regulatory revival etc...; if it were to be under Regulatory compliance.

My Perception,:cool:

Thanks & Regards,
Yeshpal Mathangi
Yes, that may be true. What if they didn't have a interim step and entered it directly to electronic format?
 
Y

yeshpal

#17
Yes, that may be true. What if they didn't have a interim step and entered it directly to electronic format?
Hello Al Rosen,

Well in that case there should be Authorized written procedures to establish compliance (21 CFR 820.20(e)) and for electronic format as stated by you then there should be compliance with 21 CFR part 11 (electronic records and signatures) and Audit trail.

My perception only.:cool:

Thanks & Regards,
Yeshpal Mathangi
 
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