Good Documentation Practices (GDocP) - Where are these described in the regulations?

[TCmeddev]

Hi,

Coming from a pharma background I am very familiar with Good Documentation Practice principles. However, from a medical devices perspective I regularly see these practices not deployed, or deployed poorly. I am working on remediation of a quality management system at the moment (subject to FDA and EU MDR requirements) where this practice is not in routine use.

My question is where in the regulations is it described that records, their entries and record corrections must be done in accordance with Good Documentation Practices (e.g. single line cross out, sign/date amendments, no correction fluid etc. etc.)? Is this a hard and fast requirement within the regulations or rather simply best practice and industry standard?

I feel it is important to know the specific requirements so that I can decide how hard to push this and how flexible I can be with some of the typical reuqirements.

I've looked all over and can only really find this linked back to GMP in pharma, so any steer as to where this is mandated (or strongly indicated) for medical devices would be much appreicated!

Thanks
Tom

 

[ChrisM]

I'm not sure that I have ever seen any guidance such as references to good practices of any sort (documentation, marking etc) in any regulations.
The rule-makers don't want to run the risk of legal action etc if the guidance turns out to be inappropriate.

Sometimes you will come across industry committees etc that recommend guides on best practices, interpretation of clauses in Standards etc.

Requirements are just that, and "interpretation" is usually subjective.

It is worth considering writing your own"good practices" documentation which you may be able to use in evidenced if queried in an audit as to why you do something in a certain way

 

[chris1price]

How about 21CFR820.120..... "Such records shall be legible......" That covers would include good documentation practices.

 

[Bev D]

Being old I remember this requirement in mil-m-38510 for defense related IC products and manufacturing lines. But I can’t say for sure that it was written down specifically. I do remember that white out was abundantly available because ‘secretary’s‘ had to have it for typing (there really weren’t computers available for all to use as word processors.). So we always had to be on guard as it would sneak into manufacturing. We also had to worry about pencils and certain ink colors that wouldn’t come through on a photocopier…

 

[Ed Panek]

Auditors in the past struggled to point to exact regulatory requirements for GDP but one pointed at ALCOA.

 

[Tidge]

My question is where in the regulations is it described that records, their entries and record corrections must be done in accordance with Good Documentation Practices (e.g. single line cross out, sign/date amendments, no correction fluid etc. etc.)? Is this a hard and fast requirement within the regulations or rather simply best practice and industry standard?

I feel it is important to know the specific requirements so that I can decide how hard to push this and how flexible I can be with some of the typical reuqirements.

I've looked all over and can only really find this linked back to GMP in pharma, so any steer as to where this is mandated (or strongly indicated) for medical devices would be much appreicated!

PART 820 -- QUALITY SYSTEM REGULATION

Subpart D - Document Controls

Sec. 820.40 Document controls.
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

Excerpt COMMENT 36 from the Preamble:

The definition of ‘‘record’’ was deleted because it seemed to add more confusion than clarity. The definition was intended to clarify that ‘‘records’’ may include more than the traditional hardcopy procedures and SOP’s, for example, plans, notes, forms, data, etc. FDA was trying to clarify that ‘‘records’’ could be written, electronic, optical, etc., as long as they could be stored and controlled. FDA could not adopt the ISO 8402:1994 definition because of how the term ‘‘record’’ is used in the act, which is broader than the ISO definition. Therefore, FDA will allow the act and case law to continue to define the term.​

My comments follow:

Based only on the above parts of the CFR, is where the rules around applying dates to records (and modifications of records) come from.

Generally, the characteristics of individual (compliant) Quality Records are:

• Legible
• Accurate
• Complete

The above list is what motivates rules around colors/types of ink, how to make updates to a previous record, pagination, etc.

A Quality system ought to make sure that collectively, the Quality Records are

• Properly stored
• Retrievable
• Traceable

 

[TCmeddev]

Thanks all. Useful discussion and along similar to lines as to what I had found in that the very specific detail of GDocP in the main is not mandated , but provides a robust mechanism to ensure that the more tangible requirements around legibility, integrity and permanence / retrievability are met.

I appreciate all the feedback.

 

[Ed Panek]

I had a similar argument with our internal auditor. Its implied from the FDA via their part 11 requirements. If FDA has strict requirements on electronic data to assume its not the same for paper based documents is crazy.