Versions and revisions! Document control in eQMS software

Document control is always on of the key topics or questions when you are transferring from paper-based to an electronic quality management system.

Some software has built-in document management, others offer it as a separate paid extension for their eQMS. Anyway, as a start-up or small company with limited budget, you have to consider every opportunity in your QMS journey in finding the right software for your needs.

To make your choice easier I would like to highlight some important factors to consider from the quality point of view.

  • Control of revisions and versions of documents and records:
    Usually a document or a record is not a final outcome of one person, but several people in a team. Until it’s final approved version, it goes through a several revisions which can be difficult to track. A good document management software (DMS) should be able to register and store all the revisions and versions that a user has worked on.
  • Sending documents/records approval or review:
    First, they all need to be registered in the system, this is an important segment of document management from auditor’s perspective. Since, for your compliance needs all relevant documentation has to be reviewed and approved by the relevant person (usually QMS manager or CEO), you need to show to auditor ” The who, the how, and the when” did the review or approval. So, a good document management system should cover this issue with appropriate electronic signature-based approval implemented.
  • Back-track your documents origin:
    Beside the proper track of approval and review workflows, it is also a key segment to know who, when and why the document was originated. Every document or record is an outcome of a quality requirement or company/project event, but it’s important to know from where and from whom it comes from. Especially, when we talk about standards and regulations, there are protocols or procedures which should be well defined and documented. This is required by the auditor. You can have an approved document but if you don’t know it’s origin it isn’t worth anything.
  • Make sure your employees don’t have the ability to use an obsolete document:
    Because of constant exchange of documents between the employees it can easily happen that someone picks the wrong version of document, re-work it and sends it forward. Your document management systems should ensure, that your people won’t see obsolete versions of documents and records, but you still have to store those versions as evidence. The system should allow access to only valid and latest revisions or version of approved documents.
  • Have a separate place for your regulatory documentation (standards, SOPs, policies…):
    Making a separate directory for your standards, regulations and company documentation with limited access rights is always a good way to keep them safe and untouchable. This can be a library in your system or a Vault where documents can be locked. Also, it unburdens your auditors job.
  • Controlled access rights:
    As mentioned above, access rights to particular documents should be limited according to company or project role. No one should be able to see or edit everything, access rights should be adjustable by the main administrator of the software or by the relevant person, like the QMS manager.

These criteria should help you understand what is an effective electronic document control which would be central for a successful quality management and regulatory compliance and to choose a DMS software that will meet your requirements. A well-organized documentation strategy is the first step is putting a smile on an auditors face.
(well, sometimes anyway). Smile!

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10 replies to “Versions and revisions! Document control in eQMS software”

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  2. Alexander says:Author

    Thank you very much for your comments.

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  4. Hello, after reading this awesome article i am too happy to share my knowledge here with colleagues.

  5. Jamie O. says:

    Hey there!
    I do have to give a recommendation in QMSWrapper. I got this software a few months ago and yes, I will not lie, I was sceptical in moving from my regular paperwork to an eQMS. In particular, because I do not get along with technology but what to do, I decided to innovate and give my company a refresh in order to make things easier. After the staff guide me on how to operate the system I was shocked by how easy you can achieve your tasks. Everything in one spot without the need of searching in folders or piles of papers and the best thing is that your entire team knows where is what and who does what. Honestly, the QMS people scored in developing this product. If you ask me if I recommend qmsWrapper, my answer will be a definite YES. By the way, I read that Mike was asking about some specifications so, I hope this helps you.

  6. Mike Trebilcock says:

    I am currently looking for a software that can help me. I want to get rid of all the paperwork and start with something more practical. Something that I have just to click and follow every process or processes instead of being digging into a pile of papers that sometimes they can get either lost or damaged. I do appreciate that you guys posted this article as it is extremely helpful as it provides literally tips and guidance in this matter. I click on the link at the bottom and throw me into the page of QMS. Do you know how good it is? What are the benefits of this software compared to the other ones?

    1. Alexander says:Author

      Hello Mike.
      We are suggesting qmsWrapper software, but you can find here a lot of QMS softwares:
      You can see that the qmsWrapper is No 10.
      Check their web site too:

  7. Teyla Simons says:

    It’s great that software can control revisions and everything related to electronic handling the documentation, but when I need a hard copy of my document? How to demonstrate revision history?

    1. Sophie R. says:

      Hi Teyla! I understand your struggle with eQMS, especially when it comes to documentation. Believe me, been there. The software we are using has the option to export revision history details in PDF and we merge it with the file.

  8. Robert says:

    Very interesting article I must say. Few years ago I used the program . The company that i was working in ,they used this program for document control. I remember that this program was very easy to use and very helpful when it came to search for certain documents . Any way I’m glad that someone else is using it and talks about it .

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