Document approval through SharePoint (without signature)

#1
Deal all,

We are looking to use SharePoint to host the QMS and technical files. SharePoint allows you to approve documents through automation/flows. This approval is recorded in the documents' metadata, providing details of who approved it and when, but there is no evidence of this approval in the document (i.e. there is no electronic signature manifestation on the document). Although we are investigating whether a log of the approvals could be created for each document and its revisions, when the file is downloaded this metadata information is not downloaded with it.

If the necessary software validation is performed, would this be an acceptable way to show approvals during an audit or would electronic signatures be required? Has anyone used this method before?

Thank you!
 
Elsmar Forum Sponsor
#2
Deal all,

We are looking to use SharePoint to host the QMS and technical files. SharePoint allows you to approve documents through automation/flows. This approval is recorded in the documents' metadata, providing details of who approved it and when, but there is no evidence of this approval in the document (i.e. there is no electronic signature manifestation on the document). Although we are investigating whether a log of the approvals could be created for each document and its revisions, when the file is downloaded this metadata information is not downloaded with it.

If the necessary software validation is performed, would this be an acceptable way to show approvals during an audit or would electronic signatures be required? Has anyone used this method before?

Thank you!
This is in fact an area I have worked with a LOT for over a decade now. I've used SharePoint systems for many different companies with a LOT of success with 3rd Party Audits. There are several ways to handle it properly, but it can be done. The fact that SharePoint in its version history maintains the user ID and time stamp, that is as good as a signature, in fact better, its harder to fake. The catch is you have to be diligent to make sure you update the document properties say in the header of the Word or PDF to match. There are some ways to do this in an automated way, but its not without difficulty. The best way is to just manually set the details, and click approve.
 
#3
This is in fact an area I have worked with a LOT for over a decade now. I've used SharePoint systems for many different companies with a LOT of success with 3rd Party Audits. There are several ways to handle it properly, but it can be done. The fact that SharePoint in its version history maintains the user ID and time stamp, that is as good as a signature, in fact better, its harder to fake. The catch is you have to be diligent to make sure you update the document properties say in the header of the Word or PDF to match. There are some ways to do this in an automated way, but its not without difficulty. The best way is to just manually set the details, and click approve.

Thank you for your message, kchambers! What exactly do you mean by "update the document properties say in the header of the Word or PDF to match"? Would we have to somehow record the approval on the document? We can't rely on the metadata alone?
 
#4
Thank you for your message, kchambers! What exactly do you mean by "update the document properties say in the header of the Word or PDF to match"? Would we have to somehow record the approval on the document? We can't rely on the metadata alone?

I think you, like many others, are trying hard to avoid putting those initials, or date stamp on the doc, and just let SharePoint manage it. if you are using Word or Excel or PDF files, you cannot get away from it. Cause the moment it is removed from SharePoint say by copy/paste or print then that copy of the doc is fully uncontrolled, we could not tell looking at it or an older version or some draft version that got scrapped what copy is "approved"

I've had customers before type up all their docs in basically a SharePoint Wiki, and then the approval info can be part of the print out or the PDF export. but there are a lot of limits to the online Wiki for documentation. I've only see it work with software and electronics companies cause their people are already all into tech and web based. The average user still wants a Word or Excel doc to edit, and truthfully cannot navigate editing inside a Wiki in SharePoint.

I sit in a weird spot in the industry, I am a Lead Auditor, spent 8 years as QHSE Manager, an I have my MCSE for SharePoint Development...

If you want, give me a call. 281-906-5415. I'm bout to hop on a support call, but should be free in the next hour.
 

Tagin

Trusted Information Resource
#5
We used this in our old QMS setup and there was one big gotcha: the SharePoint approval history became unlinked with the records after 60 days, for performance reasons. The history was actually still in the system, but in a separate Workflow History table; by searching for the record number of the document in that history table you could find all the associated approvals, but it was clunky. I'm not sure this is still true with SP 2019 or SP 365, but it caught us off-guard! This article describes it in more detail:
SharePoint and the Vanished Workflow History - European SharePoint, Office 365 & Azure Conference, Amsterdam, 2020,

According to this MS page, it was still true as of SP 2016:
All about Approval workflows
The activity in a workflow can be monitored and adjusted from a central status page, and the history of events in a workflow run is maintained for 60 days after completion.
 
Thread starter Similar threads Forum Replies Date
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
Q Does ISO 9001 Requirement for Document Approval (a service organization) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Supplier Approval of electronic document storage service ISO 13485:2016 - Medical Device Quality Management Systems 8
C Document Management Solution for Routing Documents for Approval Manually Document Control Systems, Procedures, Forms and Templates 18
M How to document approval of Organization Charts Records and Data - Quality, Legal and Other Evidence 6
I Electronic vs. Paper Copy Document Approval Process Document Control Systems, Procedures, Forms and Templates 9
C ISO27001 - Document Creation and Approval Requirements IEC 27001 - Information Security Management Systems (ISMS) 4
V How do you manage the Review Comments post to Approval of a Document Document Control Systems, Procedures, Forms and Templates 3
A Document Approval Requirements in an ISO 13485 and FDA System Document Control Systems, Procedures, Forms and Templates 7
L ISO 9001 Document Review and Approval Form Requirements Document Control Systems, Procedures, Forms and Templates 6
somashekar Document Approval per Sec. 820.40 (a) of 21 CFR part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Evidence of Approval in an Electronic Document Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Considering a Time Limit for Document Approval Document Control Systems, Procedures, Forms and Templates 22
T Document Approval Process for Company Documents Document Control Systems, Procedures, Forms and Templates 20
K Can a document approval be in the form of password? Document Control Systems, Procedures, Forms and Templates 22
S Document Approval for Adequacy Prior to Use Document Control Systems, Procedures, Forms and Templates 10
J Evidence required for Document Approval? Document Control Systems, Procedures, Forms and Templates 10
B Document Approval when the responsible person leaves the company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Posting of Initials or Names on a Computer Document as Proof of Approval or Task Done Document Control Systems, Procedures, Forms and Templates 3
S Defining Document Review and Approval responsibilities - ISO 13485 - Medical Device Document Control Systems, Procedures, Forms and Templates 3
S Document Approval Matrix - What manager needs to sign what documents Document Control Systems, Procedures, Forms and Templates 11
T Document management software - Legacy document approval history Document Control Systems, Procedures, Forms and Templates 3
Ajit Basrur FDA Requirements for Document Approval by Quality Department US Food and Drug Administration (FDA) 6
S Document Control (Need an Approval Form) - ISO 9001 clause 4.2.3 Document Control Systems, Procedures, Forms and Templates 35
A Document validation / authority - E-mail based approval system - Ideally MS Outlook ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Document Review and Approval Form - Examples Attached Document Control Systems, Procedures, Forms and Templates 11
W Approval of Electronic Documents - How do we indicate "document approval"? Document Control Systems, Procedures, Forms and Templates 9
D Approval of a Single Electronic Document for Multiple Locations? Document Control Systems, Procedures, Forms and Templates 6
M What is the proper way to document measurements Measurement Uncertainty (MU) 1
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Mylar plot suppliers in accordance with D6-51991 document AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Nitpicking on document released dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Refusal to Document Complaints Customer Complaints 39
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 Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom