I'm Brendan Hyland. I help regulated facilities transform their software, spreadsheets, workflows and documents from time-consuming, deviation-invoking, regulatory burdens, to the competitive advantage they were meant to be. Join me every week as we take a few minutes to explore, design, test and improve the critical systems we use in our facilities.
Taking advantage of a digital workflow: do you really need to implement the “routing form”?
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Electronic signatures are not a 1-1 replacement for every place you might use a paper signature or initial. This has implications when you’re taking a previously paper-based process and going digital - to try to convert the SOP step-for-step and record-for-record into the digital medium would be to lose some of the benefits of a digital workflow. Let’s say you’re moving a document review and approval workflow to a digital system. If you’ve chosen your software carefully based on pre-written requirements, you should have something that implements various niceties in the name of compliance, like:
So do you really need to keep the “routing form” that used to follow documents around to capture reviews and dates? No! The system keeps track of who did what already. Similarly, do you really need a formal electronic signature of each of the reviewers, or is the fact that they logged in and clicked on the button to send the document along sufficient? Of course, that depends on your use case. But keep this in mind: in many cases, the regulations may only require the signatures of one or two specific roles for approval. For example, the FDA GLPs say : “The date of approval of the protocol by the sponsor and the dated signature of the study director.” The GPPs say that all "methods and procedures that, prior to their implementation, have been approved by the QAP". In either case you might have a whole whackload of reviewers and approvers outside that, especially if you’re putting the thing through a change control process - department or peer reviews, quality reviews, management, etc. - but in the end the only electronic signatures on the record that need to be there from a regulatory standpoint are a) the ones they name and b) anything else that you've required in your SOP, since the regulations require you to follow your SOPs. But you can replace some of those in the SOP if some other digital record meets the bill. Why is this important? Because an electronic signature is not always available, or practical, or convenient, or as traceable as you might need it to be. Until next time, thanks for reading! – Brendan p.s. Enjoy this message? Read more at the Hyland Quality Systems website. |
The Daily HaiQu
I'm Brendan Hyland. I help regulated facilities transform their software, spreadsheets, workflows and documents from time-consuming, deviation-invoking, regulatory burdens, to the competitive advantage they were meant to be. Join me every week as we take a few minutes to explore, design, test and improve the critical systems we use in our facilities.
I'm excited to be presenting at the 2025 SQA Annual Meeting next week - "Is it the Right Tool for the Job? How QA and Regulatory Professionals can Guide Software Decisions in Regulated Environments" As our familiar software tools become more feature-laden and generalized, it's critical to ensure that software meets clear use cases and basic user requirements. And with generative AI being shoehorned into every platform, defining if and how software is appropriate for the intended use has never...
Last time we left off with a cliff-hanger of a question: How do you prove you're you when signing a document? There are several ways I've seen that the 3rd party providers prove that it's you who's signed the document: You clicked a link from an email. You paid for the service with a credit card. You provided some government issued photo ID. Someone, such as a notorized public or your HR department, has verified it's you in person. Obviously these are very different levels of assurance. Then...
There are several levels of 'signatures' that you can apply to an electronic document. The first and most basic is just an image of your written signature. One common option for this is to print the document, sign and scan it back in again. A more convenient version is to have an image of your signature saved that you can paste into documents. This is what many free versions of pdf software and word processors offer as a basic document signing option - a 'stamp' of your saved signature image....