Is anyone aware of a software that handles Document Review and Approval, QMS Change Control and Training Records related to change? Preferably Part 11 compliant and ideally validated by the provider (although I'm asking a lot there). My current company has pretty good systems for the rest of the QMS, but this area is very manual and I was wondering if anyone had come across a system for handling this as otherwise, I'm going to end up making one myself.
Electronic Document Management System
- Thread starter DanMann
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EricHeyworth
Starting to get Involved
Definitely recommend Cognidox. Speak to Claire Gaskell and she can sort out a demo for you.
Website Cognidox.com
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Website Cognidox.com
Moderator Note: Removed email address that had been included in post. In an effort to reduce spam or malicious behaviour, users are encouraged to not post email addresses. If you are sharing such information, it is recommended that private messaging be used.
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Enghabashy
Quite Involved in Discussions
ISO IEC 27001 for information security & ISO IEC 27002 could provide main guidance , anyhow any software & applications shall meet the ISO 9001 requirements & other applicable work guidance
Hi Enghabashy - was this in the right thread?
Enghabashy
Quite Involved in Discussions
Cognidox supports standards-compliant procedures for information governance. Document control procedures are a crucial requirement of ISO 9001, ISO 13485, ISO 27001, 21 CFR Part 11, and most other quality certification standards.
While I don't ignore the compliance aspects of software meant to support (various) QMS activities; in this era I think it as least as important to look at the licensing costs of implementing any system. There are several vendors who have reasonable software solutions, but come with onerous licensing costs and restrictions.
One example: if an organization intend to use the software for document control, the organization may not want to have to purchase/assign/administrate a license to every employee in the organization to be able to retrieve the "current" version of documents.
One example: if an organization intend to use the software for document control, the organization may not want to have to purchase/assign/administrate a license to every employee in the organization to be able to retrieve the "current" version of documents.
Zero_yield
"You can observe a lot by just watching."
blackholequasar
The Cheerful Diabetic
We use QCBD and have had success with it. Depends on the scope of your documents and QMS! I'm not affiliate with QCBD at all, but I've installed it at two different employers and it is also Part 11 compliant.
MattMantraSystems
Registered
We use Cognidox. While other systems had limited capabilities, we found Cognidox's DMS ticking all the boxes for us at Mantra Systems.
Without Cognidox's advanced functionality we would not have been able to maintain the alignment that was required for the EU MDR. What we like about the DMS is that you can tailor the system to be specific to our exact requirements for version control and access control while giving us the ability to link the documents together and have them speaking directly with each other.
We also find that it is very reliable when managing document approval from remote settings.
Without Cognidox's advanced functionality we would not have been able to maintain the alignment that was required for the EU MDR. What we like about the DMS is that you can tailor the system to be specific to our exact requirements for version control and access control while giving us the ability to link the documents together and have them speaking directly with each other.
We also find that it is very reliable when managing document approval from remote settings.
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