Canned Document Control Software - Is it for you?

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
As many of you probably know, I believe that canned document control software is basically a sham. With this in mind, please consider the following:

*********************
From: ISO Standards Discussion
Date: Wed, 16 Aug 2000 08:17:26 -0500
Subject: Re: QSI Software /Mower/Andrews

Shawn inquired;
"Does anybody use the Quality Systems International System 9000 software based on Lotus Notes? Does anyone have any recommendations for or against it?"

Shawn,

When I first looked into using an "off the shelf" product that worked under Lotus Notes (our company communication software) I soon realized that I had two choices:

1) - design our QMS around the structure of the "off the shelf" product (not a very efficient approach)
2) - redesign the "off the shelf" product to fit the way we did business (time consuming and still had to compromise to fit the software)

I decided to design our QMS system from scratch in Notes. I designed it to reflect the way that we do business and to enhance our effectiveness. It took some time to do (but so would #2 above); however, we now have in place a fully customized series of applications that are taylor fit to our needs. Also, the (programming) knowledge gained along the way has enabled us to further expand our Notes based systems to fulfill a wide variety of needs throughout the organization.

It was quite some time ago when I first investigated the "off the shelf" products so I'm sure that they have come a long way; however, I still believe that any "off the shelf" product will require you to remold your system to some degree to fit their program.

Hope this is helpful.

Ethan
**********************

Comments, folks?
 
Elsmar Forum Sponsor
J

James Gutherson

#2
I agree whole heartedly with Ethan (I missed this thread on the list serv, thanks Marc). I started to build our system with canned Doc Control software, but found it (the doc control software) was pushing me away from the overall vision I had. Our system is now based around elements we were already using M$ Office, Outlook and Exchange, and Webpages. The only additiion has been (and I know Marc does not agree with extras) Adobe Acrobat. Acrobat was originally used to correct formatting problems when printing on different printers in regional offices, but has been shown to have other benefits for version control (eliminating the need for passwords). Overall this self built system is magnitudes of order more effective than the canned system, and significantly reduces training times.
Our only problem has been speed of access for the regional offices, actually the problem is convincing the bean counters that the cost of speeding up the wide area network will be offset by gains in productivity :) .
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Acrobat I can handle - It's relatively useful. I do prefer to KIS - Keep It Simple.
 
Thread starter Similar threads Forum Replies Date
E Missing Records, Document Control and Canned Document Content Issues Document Control Systems, Procedures, Forms and Templates 1
A What Electronic Document Control Software are you using? 'Canned' or In-House? Document Control Systems, Procedures, Forms and Templates 10
GreatNate Various Audit Templates - Canned forms and templates Document Control Systems, Procedures, Forms and Templates 9
S Any recommendations on canned ISO 9001 documentation? Document Control Systems, Procedures, Forms and Templates 3
M More than canned audit check-sheets? Auditing the Engineering Department Process Audits and Layered Process Audits 5
D Where to buy "canned" Medical Device QMS Procedures and Documents IEC 62304 - Medical Device Software Life Cycle Processes 12
A ISO 9001 "Canned" Templates Document Control Systems, Procedures, Forms and Templates 8
N ISO 9001:2008 Self Certified using "Canned" Procedures to ISO Certified by Registrar ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
H ISO 9001 Documentation Templates ('Canned' packages) advice Document Control Systems, Procedures, Forms and Templates 4
Q Canned ISO system for implementation and certification Document Control Systems, Procedures, Forms and Templates 8
S Packaged ISO Systems - Are canned policies and procedures worth it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 49
Ajit Basrur FDA warning on canned French Cut Green Beans US Food and Drug Administration (FDA) 4
R Any experience with iMarkup software? Possible Substitute for Canned Quality Software Quality Assurance and Compliance Software Tools and Solutions 1
N We have one of these so called "canned systems" Career and Occupation Discussions 19
A Electronic Records for FDA - Canned computer program for our Corrective Action system Records and Data - Quality, Legal and Other Evidence 3
Marc Canned Documentation - Buying Forms and Procedures - Are the worth it? Document Control Systems, Procedures, Forms and Templates 1
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
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
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
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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 Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
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
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 14
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Sidney Vianna Informational New IAQG Document - AS9100 Clarifications of Intent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom