Generally speaking, QMS software may make your life easier in three areas: requirements management, fancy features, and document management. Let’s examine each of the three.
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QMS Software as a System for Document Management
You must create legitimate electronic signatures on papers and preserve previous iterations of documents in order to comply with regulations. Although those two items seem insignificant, they aren’t always—or in reality—trivial.
The regulations pertaining to electronic signatures vary depending on the nation you’re in and the regulatory body you’re seeking to comply with. Said another way, EU regulations for medical equipment are more lenient than US ones. While the US FDA needs e-signatures that comply with a rule called 21 CFR Part 11, you may very much come up with your own implementation and use any tool you like in the EU.
To put things even simpler, all you would need to do to sign a document in the EU is use Google Docs and enter your initials in the signature table at the bottom. This works since you can see who signed the document and when thanks to the version history feature. That wouldn’t work in the US, and you’d need a tool that complies with regulations, which Formwork is, incidentally.
Older versions of documents must be archived in addition to legitimate e-signatures. That’s also simple to do, but depending on the tool you choose, it may become laborious. You cannot completely rely on a document’s (internal) version history if you are using GDrive for document management since there is no concrete assurance that it will survive indefinitely. For example, a document’s version history is lost when it is copied. As a result, you must archive each duplicate of a document for each version and copy and paste it whenever you wish to make changes. It hurts so much, ugh.
For your QMS version control, you could, of course, use something like GitHub or GitLab, but it would require that every member of your team be able to produce markdown files, which is usually not the case for regulatory personnel. That’s where document editors and correctly preserved document versions—which, again, Formwork handles very well, but certainly check out how other QMS software does that, too—are two genuine, practical benefits that QMS software generally offers.
QMS Software Boasting Stylish Features
Let me ask you this now: So QMS software is just a fancy way of saying “signing and versioning documents”? In general, I concur with you. The majority of QMS software available is developed by businesses and marketed to businesses. Put another way, it’s really awful! It frequently appears to have been erected in the 1990s and never upgraded, which may or may not be the case.
More “modern” (laughing) QMS software frequently comes with extra functionality. There is no general feature set for these functions, unlike document management above, because they truly rely on what the software provider created. Just to help you comprehend, I’ll go over a few instances from Formwork.
User Training: You must demonstrate that your staff members have received training on your company’s procedures in order to be in conformity with EU ISO 13485, which is the standard for medical devices. Even while it sounds absurd, it actually causes a lot of trouble with documentation. Businesses usually “fix” issue by having remote or in-person training sessions, following which all participants must (electronically) sign an attendance sheet. Employees may even have to complete a quiz after work. I wonder if you treat your staff like this; if they leave and go to Google, I wouldn’t be shocked. Anyhow! To lessen the suffering, QMS software can include built-in training modules that provide users the papers they need to read and produce documentation (such as an attendance sheet) attesting to the user’s training.
Audit Preparation: Usually, you have to submit all of the papers in your QMS for audit. This may be rather difficult depending on how you handle them. For example, if you use GitHub, do you have to convert all markdown files to PDFs and attach them? Well. In any case, you may save a ton of time when using the batch-export option of QMS Software.
“Ticketing” Items: There are specific items that must be monitored in order to maintain medical device compliance. These consist of complaints of issues with your program, for instance. All of those must be documented, along with evidence that you evaluated them and tracked the issues’ resolution. Spreadsheets or Jira are frequently used for this, which leads to a messy result. These can occasionally have specialized forms in QMS software, which makes keeping track of them easier.
QMS Software for Management of Requirements
And lastly, requirements management may be aided by QMS software. Since requirements management is often carried out via requirements management software, this is essentially outside the purview of this discussion. However, because requirements management and quality management are sometimes mandated by the same laws and carried out by the same individuals, the distinctions are becoming more hazy, particularly with regard to medical devices. Thus, it makes logical to combine them into a single piece of software in the hopes that using it will benefit the businesses that use it.
Requirements management: what is it? Basically, what regulators term “design input” is a list of all the features you planned to include in your program; “design output” is the implementation of those features; and “verification” is the process of ensuring that the features were constructed appropriately, such as via software testing.
In the end, this is basically a long list of linked items that are many to many. For example, you may have design input for an app that diagnoses Covid; that feature might then be implemented in a variety of ways (design output); moreover, you may have several tests that address that feature (verification). You have undoubtedly realized by now that entering this kind of data into spreadsheets leads to an enormous amount of chaos. But that’s actually how most businesses operate! Oh, how agonizing.
Software comes in quite handy here since many-to-many relations are simple to set up.
Now, why not just use Jira tickets or GitHub problems (ugh) for that? Yes, in principle, but you also need to maintain previous versions of your tickets, just as with document management! It’s actually rather difficult since you also need to maintain the relationships. For example, even though you are now working on version 5.0 of your program, you still need to demonstrate the design inputs you had for version 1.0 and which verification addressed those.
Thus, technically speaking, this is challenging. One workaround could be to export every ticket you have on GitHub along with all of its related tickets as a PDF and save it elsewhere. But naturally, that is awful.
When we designed Formwork, this was one of the trickiest technological problems we had to address. However, to the best of my knowledge, other QMS providers have also addressed this issue, albeit in a less satisfactory manner.
