Can a document approval be in the form of password?

S

samsung

#11
There is no requirement for signatures. The requirement is that documents are reviewed for adequacy prior to release, so you need to have evidence that review was done. One way to do it, if you're using a Microsoft Exchange server, is to use e-mail voting buttons.
But clause 4.2.3 also requires the documents be approved prior to release:

to approve documents for adequacy prior to issue,
Hence some sort of approval is essential.
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#12
But clause 4.2.3 also requires the documents be approved prior to release:

Hence some sort of approval is essential.
If, for example the documents are electronically controlled, a simple paragraph in the document control procedure can state that only approved documents are maintained on the system. All printed copies can be declared valid for a limited time period or they can be declared uncontrolled. Whatever works best. This topic has been dicussed many times here.

Stijloor.
 

Jim Wynne

Staff member
Admin
#13
But clause 4.2.3 also requires the documents be approved prior to release:



Hence some sort of approval is essential.
Yes, I said that evidence of approval is necessary. There are many ways to preserve evidence of approval without actual signatures. I don't know if you're familiar with the concept of voting buttons in MS Office, but it involves sending an e-mail message wherein there are buttons one can click on to signify whatever you want them to signify, such as approval (or disapproval) of a document. The results are stored in a defined location where they may be retrieved to show evidence of what took place.
 
D

dv8shane

#14
ISO 9001 4.2.3 a)

Can the approval be in the form of password protection? If it can be, using this method what's the common practice of recording approval and release?
From the e sign act which was designed for consumer contracts the legal definition is
"(5) ELECTRONIC SIGNATURE.—The term ‘‘electronic signature’’
means an electronic sound, symbol, or process, attached
to or logically associated with a contract or other record and
executed or adopted by a person with the intent to sign the
record." The whole document is here

http://frwebgate.access.gpo.gov/cgi...=106_cong_public_laws&docid=f:publ229.106.pdf

I think as long as you specify the procedure to create the approval and use this as a basis in law for your definition of electronic signature whatever procedure you create could be legal and binding.

Shane
 
Q

quality person

#15
The signature can also be a digital signature. There are some websites like - online tax payment etc which accepts digital signature(not sure on the technical pre- requisites though) its still accepted as a signature. Again it depends on whats mentioned in the control of documents procedure.
 
#16
Folks tend to make document approval a lot more burdensome than need be. The question is how does your organization know a particular document was approved? In small companies, verbal approval may be sufficient. Or even the existence of the document may be sufficient. If I am the creator and the approver of a document, why would I need some artificial means of approval? If I created a document, and am using it, I think that would constitute approval.
The larger and more complex the organization, or processes, then you would undoubtedly need more complex document control system. But use common sense.
 
D

dv8shane

#17
Dave
I do not think this would pass with any auditor. They would want the name of the person approving for release and the date it was approved. My business is a one man shop and there is no way my auditor would have let something like that be approved

If I am the creator and the approver of a document, why would I need some artificial means of approval? If I created a document, and am using it, I think that would constitute approval.
In fact after reviewing e sign act as a law I think there are lots more areas that are effected under by it under the Statutes and Regulatory Authorities that are referred to through out the clauses located in ISO 9001 AS9100etc. . The fact is auditors are usually unaware there is a legal definition of electronic signature. Any thoughts?

Shane
 
#18
Dave
I do not think this would pass with any auditor. They would want the name of the person approving for release and the date it was approved. My business is a one man shop and there is no way my auditor would have let something like that be approved
So, you are a one man shop, and you need some form of documentation to prove you approved a document you created? I would toss any auditor out if they said that. What value is it to document you approved a document you created? If you didn't approve it, you wouldn't use it?

I had an auditor one tell my client that they needed written documentation that all of their employees understood the quality policy! What utter nonsense!

However....


In fact after reviewing e sign act as a law I think there are lots more areas that are effected under by it under the Statutes and Regulatory Authorities that are referred to through out the clauses located in ISO 9001 AS9100etc. . The fact is auditors are usually unaware there is a legal definition of electronic signature. Any thoughts?
Shane
This is an entirely different and more complex scenario. If there is some legal, regulatory, statutory, or even customer mandate for electronic signatures, then you have to meet the requirements. Depending on what standard you are relating to, you might need more detailed approvals. My comments were for just the ordinary document control procedures found in ISO 9001.
 
D

dv8shane

#19
However....
This is an entirely different and more complex scenario. If there is some legal, regulatory, statutory, or even customer mandate for electronic signatures, then you have to meet the requirements. Depending on what standard you are relating to, you might need more detailed approvals. My comments were for just the ordinary document control procedures found in ISO 9001.
This is US law that sets precedents. I actually quote the law and definitions as part of my ISO 9001:2008& AS9100B registered and ISO 17025 compliant quality system Per my understanding legal statutes over ride ISO 9001 requirements and in fact this has a lot of ramifications that every auditor I have spoken to had no knowledge of. Did you know this law and legal definitions even existed?

Shane
 
#20
If my memory serves me correctly, electronic signatures are part of 21CFR part 211 (forgive me if that is incorrect). However, that applies where regulatory signatures are normally required. The original poster referred to ISO 9001, and the CFR's don't apply to all documents. From strictly an ISO 9001 standpoint, no form of approval is dictated. It is not imperative that you do anything to please the auditor. If your organization understands how documents are approved, and can tell if a document has been approved, then it is your quality management system and your rules.
 
Thread starter Similar threads Forum Replies Date
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L ISO 9001 Document Review and Approval Form Requirements Document Control Systems, Procedures, Forms and Templates 6
S Document Control (Need an Approval Form) - ISO 9001 clause 4.2.3 Document Control Systems, Procedures, Forms and Templates 35
T Document Review and Approval Form - Examples Attached Document Control Systems, Procedures, Forms and Templates 11
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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
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
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
A Document validation / authority - E-mail based approval system - Ideally MS Outlook ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
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
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
J UDI - Where to document it? EU Medical Device Regulations 8
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
S Changing revision status of a reviewed document Manufacturing and Related Processes 4
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Document ownerships Document Control Systems, Procedures, Forms and Templates 14
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
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

Similar threads

Top Bottom