Document Control Features (Document Content Requirements) and 21 CFR 820.40

JeantheBigone

Quite Involved in Discussions
#1
Quality system documents typically contain features such as :

Title
Version / Revision number
Effective / Authorization date
Number of pages
etc.

and sometimes contain an expiry date on which the document is to be reviewed for changes / re-approval.

21 CFR 820.40 does not specify this level of detail, nor does ISO 9001;2008 or ISO 13485;2003. The only standard I have seen which explicitly requries specific fields is ISO 15189.

My question is what is the source of these individual fields? Is there a standard that specifies which fields must be included or is it simply good accepted practice?
 
Elsmar Forum Sponsor

Pancho

wikineer
Super Moderator
#2
As you say, there is no requirement for those specific fields in 21 CFR 820.40, nor ISO 9001. So as quality system documents typically contain them, they must assist in fulfilling other requirements in those standards.

ISO 9001 4.2.3e and c, for example, require you to determine the controls needed to identify documents, their changes and their revision status. Seems obvious that having a title, a version or revision number, and effective dates on a document are simple controls that help meet those needs.

21 CFR 820.40 b does require you to save certain information beyond ISO 9001, such as signature of the approving person when a change is made to a document. It does not say that such info need be right on the document, though that is probably a good place for it.

Nevertheless, when you are designing your QMS, be careful not to create busywork. Number of pages is one example of a likely useless field that is indeed fairly common. I guess it may have provided some sort of redundancy check when documents were done by hand, and it became easy to leave on when office software counts the pages for you. But if after considering your particular standard, it doesn't seem like you need a field, then you likely don't. Chuck it.

Good luck!
 
Last edited:

sagai

Quite Involved in Discussions
#3
Hello there,
the "source" is likely your former collegues recollection over how to cope with regulatorty requirements.
May be it is more than you would expect to see, may be less.
It is based on their experience, awareness and their level of risk tolerance.

"signatures for document change" is a slippery slope, you should decide wisely what to consider as a change, more importantly what does relate to design change.

So sum it up, if I could have an advise than what you think is the most useful for your company :)

Cheers!
 

JeantheBigone

Quite Involved in Discussions
#4
Thank you for the replies.

To clarify, this is not at my company. I am consulting and performed an audit of document controls for a client. There were document control SOPs and forms that did not have an effective / implementation / authorization date in the header fields. My reaction was to flag it; it certainly is helpful when auditnig to know which forms go with which SOP. :) Then I found that I was unable to find a specific requirement for it so I feel I don't have a "case.".

The only concern that the client has is that the lack of date field not be flagged by an FDA inspector and their preference is to leave the date off the documents in question. All other documents I've reviewed (for document control as well as others) have a date field in the header.
 

sagai

Quite Involved in Discussions
#5
I would look for the intent of the CFR to see if they have any answer for that.
Dates in documents do not necessarily needed, there are plenty of other way to comply with the CFR recently with computerized document management systems. Also there could be manual measures where we do not need date in document.
It could be actually that they are unconsciously complying with the CFR too.
Cheers!
 
Thread starter Similar threads Forum Replies Date
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
O Vendor vs Engineering Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Document Control Software Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
I Document Control Workflow Document Control Systems, Procedures, Forms and Templates 2
D ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions Document Control Systems, Procedures, Forms and Templates 51
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAF Mandatory Document #23 - Control of CB Franchisees and Agents Registrars and Notified Bodies 3
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
D Software for advancing with Document Control Quality Assurance and Compliance Software Tools and Solutions 4
L IATF 16949 Cl. 7.1 - Lotus Notes for Document Control IATF 16949 - Automotive Quality Systems Standard 0
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Document control for tooling drawings (Document control clause 7.5.3) IATF 16949 - Automotive Quality Systems Standard 5
J Document Control Newbie - Control of Nonconforming / Returns Log AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
P Document Control - Do hard copies of documents need to be signed? Document Control Systems, Procedures, Forms and Templates 3
R External Standards List (Document Control) Document Control Systems, Procedures, Forms and Templates 3
M Retiring documents in Document Control Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
M Cross Function Process Map for Document Control Process Maps, Process Mapping and Turtle Diagrams 3
0 How to deal with resistance to GDP Document Control Discipline Document Control Systems, Procedures, Forms and Templates 7
dubrizo Restructuring Document Control Numbering System Document Control Systems, Procedures, Forms and Templates 3
G Migrating to an ISO 13485:2016 Compliant Document Control System ISO 13485:2016 - Medical Device Quality Management Systems 6
E Document Control MS Access Database Document Control Systems, Procedures, Forms and Templates 39
S Looking for Document Control Templates Document Control Systems, Procedures, Forms and Templates 1
S Document Control Guidelines in Engineering Projects - Excel sheets with VBA coding Document Control Systems, Procedures, Forms and Templates 3
E Challenges in document control, revisional control, and change control Document Control Systems, Procedures, Forms and Templates 8
tony s Performance Indicators for Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2
T Document Control of FMEAs and Control Plans FMEA and Control Plans 5
T Is there a difference between form control and document control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
x-files Proper Document Control Requests Document Control Systems, Procedures, Forms and Templates 1
D Nonconformance on document control - Unapproved document on production server Document Control Systems, Procedures, Forms and Templates 4
M Where does Document Revision Control Start? Rev 0 or Rev 1 Document Control Systems, Procedures, Forms and Templates 19
I How to build a Microsoft Access MDB Database for Document Control Document Control Systems, Procedures, Forms and Templates 6
I Document Control - Document Revision History Question Document Control Systems, Procedures, Forms and Templates 16
M I Attached My first Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L ISO 13485 Document Control - Document Changes - Needing Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 1
Gman2 My Attached Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Simple ISO 9001 Compliant Document Control Quality Manager and Management Related Issues 24

Similar threads

Top Bottom