"Typing name on MS.Word directly" can be "Electronic Approval Signature"

THEERANART

Starting to get Involved
#1
Dear Cove friends,
We control document by intraner on Dive:V (Document Control Management Drive) .All items with current version can be accessed any time by anybody (read only).
There are about 36 functions (sections) in our organizations that are required to use document differently. Before I(QMR) is creating system for approve docuemnt . Normally we have 4-5 blank cell for each managemnt team to sign. But we lost time because Document Ccontrol officer have to walk to each working desk for approval all, take time more over 5 day.
I would like to reduce time by think idea as step below.

1. I will creat 36 folder by each approval authorize and 3 folder (Awaiting approaval , Approved, Disapprove, he can access only individual name by name. IT engineer has set permission to access only themself.
2.When he has document to sign, he will typing their name . (That mean he has alredy approved.
3. All appravoal signature do within each individule folder.
4.The officer (dcc) will move approved docuemnt to the intranet (Everyone can access as read only , that mean controlled document.)if are printed out that will be uncontrolled)

I would like to know
1. Is it comply with ISO9001 4.2.3 and 4.2.4 or not?
2.How is external auditer(CB) think? Can get NC or not.
3.What type of docuemnt can join this Electronic Approval Singnature.

Sorry , I am not good at English. I hope you will understand my point.

THANK YOU FOR YOUR RECOMMEND.
 
Elsmar Forum Sponsor

Mikishots

Trusted Information Resource
#2
Re: " Typing name on MS.Word diretly" can be "Electronic Approval Signature"

The external auditor will verify that the documents are approved for adequacy prior to issue. One signature or 100, it depends on how the organization wants to deal with it. Is five signatures necessary?

A very popular method for applying digital signatures is Adobe Acrobat. If Doc Control has a full copy of Adobe Acrobat Pro, they can set up the .pdf's to be digitally signed by any other person in the company that uses Adobe Reader 10 (which is free). We have been using this method for a while now and it's very quick and simple.

Decide which people have signing authority. The more people you define, the more cumbersome the system gets - don't overdo it.
 

somashekar

Staff member
Super Moderator
#3
Re: " Typing name on MS.Word diretly" can be "Electronic Approval Signature"

If you are able to show effective control and have documented the same in your procedure, and if it works well for you, you are good on it.
Do not worry about an unseen NC. Instead see how your method works for you to get effective understanding and thereby the effective control.
 

THEERANART

Starting to get Involved
#4
Re: " Typing name on MS.Word diretly" can be "Electronic Approval Signature"

Thanky you for your answer, I hope this method will help us reduce paper and reduce much time. I just want to give more informatin that Doccument control officer will move approved document to next person and it all have approved already, She will move to released folder.

I have read much thread about this method, diffent idea , I am so confused what I done is correct. I am no need to buy more software I have IT department can set everythings.
 
Thread starter Similar threads Forum Replies Date
Pancho Dvorak keyboard - one cure for RSI and bad typing habits Imported Legacy Blogs 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
P EU MDR Translation of Product Name EU Medical Device Regulations 0
qualprod Assign a name to a home-made ERP system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
F Hospital Rebrand & Name changes Document Control Systems, Procedures, Forms and Templates 4
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
R Process Specification - What is the name of this PPAP form? APQP and PPAP 15
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
M Referencing the MDR by name in QMS SOPs EU Medical Device Regulations 2
Marc Search for Posts - By specific User Name(s) Elsmar Xenforo Forum Software Instructions and Help 1
V Company Name Change IATF 16949 - Automotive Quality Systems Standard 1
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
L Is writing out the ISO9001:2015 standard full name a requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
M Electronic signature - name.lastname or equal to handwritten Document Control Systems, Procedures, Forms and Templates 3
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
Marc Forum User Name - I Want to Change my Forum User Name Elsmar Xenforo Forum Software Instructions and Help 0
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
Q How do we document a department name change? Document Control Systems, Procedures, Forms and Templates 3
B Company Name Change - ETL Labels and Report Updates CE Marking (Conformité Européene) / CB Scheme 2
G Chart with LSL and USL: What is it's name? Reliability Analysis - Predictions, Testing and Standards 4
J Manufacturer Name on Private Brand Labeling Other US Medical Device Regulations 12
D Document approvers by role or by name Document Control Systems, Procedures, Forms and Templates 8
JoCam Over-labelling the manufacturers name at the front of the device EU Medical Device Regulations 31
A Timeframe for Product Label Update after Company Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Canada preferred Name Code (PNC) Canada Medical Device Regulations 3
V Procedure to change the Company name in existing TS16949-2009 certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Incomplete forms and records missing date or a name Records and Data - Quality, Legal and Other Evidence 6
M Who's name should be on component certification? Other ISO and International Standards and European Regulations 2
J Macro Question: Get Column Name by Column Number / or Use Text constant to link on a Using Minitab Software 1
I Company Name Change for Establishment Registration US Food and Drug Administration (FDA) 4
I 21 CFR PART 11 Password and User Name Requirements Software Quality Assurance 3
K Medical Device Labeling Requirement - Manufacturer Name 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Company Name Change & Control of Documents Document Control Systems, Procedures, Forms and Templates 9
A Organization Name Change & Its Impact in QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B What to do when adding new Proprietary name under same 510(k) Other US Medical Device Regulations 2
P Changing the Trade Name of a cleared Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Product Name when Marketing four components as part of one product EU Medical Device Regulations 3
R New PSW due to Company Name Change APQP and PPAP 4
J File Name Revisions in SharePoint Document Control Systems, Procedures, Forms and Templates 5
M Company Split and Name Change - Name on Registration Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Name for FMEA (Risk Analysis Approach) Program FMEA and Control Plans 1
D Keeping Same Medical Device Name but Changing Classification Medical Information Technology, Medical Software and Health Informatics 3
G Company Name Change in a regulated Environment Other US Medical Device Regulations 3

Similar threads

Top Bottom