Electronic Document and Records Control Software

J

jvasqu01

#1
#1
Does anyone have any opinions on good software to purchase to make life easier when it comes time to write the QM, Procedures, and other supporting documents?

This forum has been very helpful and I want to thank all those that help people like me!

Julian
 
Download Free White Paper
Elsmar Forum Sponsor
H

HFowler

#2
#2
Julian,

I've always preferred to use standard word-processing software. Keeping the documentation simple seems to make revisions easier to maintain, year-after-year. If you use a canned software package that's specific for ISO 9001 documentation and decide later on to transition to a mainstream software, it may be difficult to convert. This can also be true if you use a lot of graphics. In my opinion, you're better off to use software that's compatable with other softwares that the company uses.

But, as I said, that's just my opnion. Read on for the views of others.

Best Regards,
Hank Fowler
:)
 
A

Al Dyer

#3
#3
Agree with you Hank,

I think this type of software can be used a reference but that the benefit of of using your own software is a good learning experience.

If you write it you know it!

I think if you use the Cayman PDF files and search function you will be able to get everything you need.:)
 
F

Fredrik T

#4
#4
I think any software will do really. A procedure could take the form of written text, processflows, pictures, television (used for promotion of gadgets in supermarkets). Though, my advice would be to use software that will work through many years of updates, ex MSOffice etc.

I have choosen to use MSWord and Excel for writing and for pictures. Visio for graphic process flow descriptions - it's easy to paste into word and you can add comments and resposibility by dividing your word document into 3 columns.

We use MS Sharepoint to mange our document system. The advantages is that it is easy to use and works without any problems together with MSOffice2000 (not really with older versions) and it is very very cheap compared to other document control systems (about 1/20th of the cost).

The best system will only have pictures, symbols and graphic process flows with reference to result documents. A good rule is that any procedure should fit on 1 A4 and the fontsize shouldn't bve less than arial 10:). If you manage this, I think the procedures even might be read and understood.

Fredrik
 
D

DICKIE

#5
#5
If I had it all to do over knowing what I do now, I would use Word, Access and Excel. This would have saved me tons of expense, training, etc. In the end I've converted to these from AQUA, Gagetrack and Powerway anyway.

Greg
 
B

Big-3-Hand-Puppet

#7
#7
Have you ever felt like a kid who know's about something new, and want's to share it with everyone? Well here's my rendition....

For something as simple as Excel, more convenient than Access & integrates with Visio for Flow diagrams, see www.fmeapro.com

We had the pleasure of trying an advanced copy with stunning new Graphical Analysis features...I wouldn't have believed it either...now I own it!

The folks at SAE seem to agree also...March 1st, they are the exclusive FMEA software supplier to the SAE membership...
www.sae.org

Big-3-Hand-Puppet:bonk:
 
R

Richard Flexton

#8
#8
Various - have a look

I have used Qpak, Qpulse, Proquis and Quality Workbench - they are all OK but it really depends what your requirements are. If you need good traceability and control then Word or excel aren't goiung to do it. If you have lots of users I would look at Workbench or Proquis enterprise.

I would also look at mapping my processes in allCLEAR so you can analyse them for bottlenecks and cost of quality.

Just a few practical thoughts.
 
J

JodiB

#9
#9
For writing manual and procedures I'm using Word and Visio.

For doc control - so far just plain old Adobe and restricted directories. Pain in the neck and looking forward to getting a software solution.

Richard, Proquis is one of the software pkgs I've looked at and it seems like it would work for us - but can you give me the scoop on its shortcomings? It appears to be straight Access and the screens don't look very detailed.....
 
L

Laura M

#10
#10
In addition to Lucinda's question...

How many users are involved or how large is the company using Proquis?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D 21 CFR 11 Tools Validation - Electronic Document and Records Control Qualification and Validation (including 21 CFR Part 11) 5
M Paperless Electronic Document and Records Systems Software Records and Data - Quality, Legal and Other Evidence 19
D Electronic Document Management System ISO 13485:2016 - Medical Device Quality Management Systems 16
B Supplier Approval of electronic document storage service ISO 13485:2016 - Medical Device Quality Management Systems 8
P Converting DMF III into eCTD (Electronic Common Technical Document) Medical Information Technology, Medical Software and Health Informatics 4
T Electronic Document Control - Posting a process at work station ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R A simple electronic (software) document control question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Electronic vs. Paper Copy Document Approval Process Document Control Systems, Procedures, Forms and Templates 9
M Computerised (Electronic) Document Control Insights Customer Complaints 1
C Process Mapping Electronic Document Control Software Recommendations Quality Tools, Improvement and Analysis 5
D Converting to Electronic Document Control - Procedure Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
D Electronic Document Control System suitable for TS 16949 Requirements Document Control Systems, Procedures, Forms and Templates 2
V Electronic Document Control Software suggestions wanted Document Control Systems, Procedures, Forms and Templates 14
Q Evidence of Approval in an Electronic Document Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Electronic Document System - Compliance US Food and Drug Administration (FDA) 9
C Electronic Document Control in a Company - Organization of Files Document Control Systems, Procedures, Forms and Templates 16
K Master Document List and Unalterable Electronic Forms ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
V Electronic Document Control Sharepoint Questions Document Control Systems, Procedures, Forms and Templates 2
A Control of Document - Manual and Electronic Document Control Systems, Procedures, Forms and Templates 5
S Electronic Document Printing Restrictions and Access Control Document Control Systems, Procedures, Forms and Templates 4
J Qumas as an EDM (Electronic Document Management System) Quality Manager and Management Related Issues 2
F Looking for Electronic Document Control Software Quality Assurance and Compliance Software Tools and Solutions 14
A 21 CFR part 11 compliant Electronic Document Management Systems Document Control Systems, Procedures, Forms and Templates 20
S Customized EDMS (Electronic Document Management System or ADMS) Document Control Systems, Procedures, Forms and Templates 4
M What is the best Electronic Document Control Management System? Document Control Systems, Procedures, Forms and Templates 46
K Document Approvals and 21 CFR 11 - Electronic signatures and approvals Qualification and Validation (including 21 CFR Part 11) 6
CalRich How to Document Review of Electronic Documents? Document Control Systems, Procedures, Forms and Templates 2
C Document Control of Electronic Forms Document Control Systems, Procedures, Forms and Templates 6
T Training on SOPs through our Electronic Document Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Document Control - How can I switch to electronic signatures? Document Control Systems, Procedures, Forms and Templates 12
I Electronic Document Control - How do we handle document signoffs? Document Control Systems, Procedures, Forms and Templates 8
N Anybody with experience with Sharepoint portal for electronic document control? Document Control Systems, Procedures, Forms and Templates 53
A What Electronic Document Control Software are you using? 'Canned' or In-House? Document Control Systems, Procedures, Forms and Templates 10
A The cost of document control - Electronic vs. Paper Document Control Systems, Procedures, Forms and Templates 20
W Approval of Electronic Documents - How do we indicate "document approval"? Document Control Systems, Procedures, Forms and Templates 9
A Document Control: Controlling Electronic Email (E-mail) Document Control Systems, Procedures, Forms and Templates 7
D Approval of a Single Electronic Document for Multiple Locations? Document Control Systems, Procedures, Forms and Templates 6
A Document and Data Control - We are not satisfied with electronic document security Other ISO and International Standards and European Regulations 3
Ajit Basrur Electronic Records - leave non-mandatory fields blank? Qualification and Validation (including 21 CFR Part 11) 9
H European requirements for rechargeable Lithium-ion batteries going to be used in Electronic Pipette CE Marking (Conformité Européene) / CB Scheme 0
E Electronic Data Management ISO 17025 related Discussions 1
A Electronic Weighing scale calibration Calibration Frequency (Interval) 4
K 2021/2226 on Electronic Instructions for Use (IFU) for medical devices Article 22 Packs EU Medical Device Regulations 1
T Electronic Systems and 8.5.2 compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
P Can credentials (ID/PW) used to login be the same as when applying Electronic Signature (Part 11) US Food and Drug Administration (FDA) 2
V Recommended EU 2017/745 electronic submission format EU Medical Device Regulations 3
Y FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs) US Medical Device Regulations 1
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 38

Similar threads

Top Bottom