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!