Can an external checklist be uploaded in the out-of-specification?
Absolutely. There are multiple avenues for managing this. Should you wish to upload an external file from your local environment, you’ll notice within the Scilife forms an option to “upload a file.” This file need not be stored in Scilife; it can originate from your computer. Alternatively, if you prefer to integrate a document from your document control or record management, you can effortlessly link it via a Scilife field, selecting the relevant element from the module. The choice is entirely yours.
Does this workflow require additional validation?
In the context of the Quality Process Designer, which tailors workflows, it pertains to GAM category 4. While Scilife’s validation aligns with GAM Category 5, the remaining 5% of validation for the end user adopts a Category 3 approach. For the workflows crafted with the Quality Process Designer, this will be classified as Category 4. To recap, the Quality Process Designer is validated to GAM5 internally, requiring a Category 3 validation for the customer’s tool implementation. Subsequently, the workflows created fall under Category 4 validation.
Are we obligated to build our workflows from scratch?
There is no need to initiate workflows from scratch. There is an option to duplicate existing workflows. This empowers you to commence from a familiar point. Furthermore, should you prefer a customized adaptation of a specific workflow, our team can assist. For instance, if you are happy with our standard change control workflow but seek to modify it to suit a specific change process in your company, we can readily accommodate this request. We’ll provide you with the basic framework; from there, you can refine it to meet your needs.
Does the quality process designer replace your standard modules?
No. Although it is certainly possible to do so if needed, the focus is more on integration than substitution. Our offerings are structured in a suite of packages, ranging from essential to advanced, with the latter including the quality process designer. Even if you choose to utilize the designer, you’ll still have access to our other tools. This allows for a flexible approach where standard tools like CAPA, change requests, and event workflows can complement a tailored solution for out-of-specification cases. It’s about adding value rather than a complete swap. Of course, if your processes are entirely unique, implementing only the custom modules is a possibility. But in most cases, a combination of both standard and custom modules works best.
