At this point, you probably know paper just doesn’t cut it when it comes to quality management. To create a truly solid, compliant foundation of quality, it’s time to go digital.
But by “digital” we don’t mean the add-on quality function that was crammed into an existing eClinical platform as an afterthought.
Just because a system can store documents doesn’t mean it’s built to manage quality. But too often, Quality teams have to function within the software the Regulatory Affairs or Clinical teams already have in place, such as a RIMS or a TMF.
Though it might seem simpler if regulatory submissions, clinical documentation, and quality management all existed in the same place, it usually results in Quality getting the short end of the stick. Many of these “total suite” solutions weren’t designed with the real functionality Quality teams need for compliance.
So how do you know if a system is actually capable of supporting quality management?
Let’s go over the difference between RIMS, TMF, and eQMS software platforms, and the features that are critical to quality management.
RIMS stands for Regulatory Information Management System. RIMS software helps Regulatory Affairs teams track, prep, and submit regulatory filings to the appropriate organizations. In a RIMS platform, Regulatory teams can do things like:
TMF stands for Trial Master File, and TMF software is designed to house critical documents related to clinical trials, like informed consent forms (ICFs), trial SOPs, site visit reports, etc. With a TMF platform, clinical teams can:
Technically, RIMS and TMF platforms can be used for some quality management activities, though not all. Here’s what’s possible – and what’s missing – when trying to use a RIMS or TMF for quality management:
Store quality-related documents, like SOPs, forms, etc.
Track document versions
Control access with user permissions
Training Management
These systems don’t include training management workflows or automatic training compliance tracking. Instead, you’ll have to track training information for each employee in separate documents that are uploaded into the system. Managing and storing training matrices in separate places is never good for compliance, and good luck trying to report on company-wide compliance quickly.
CAPA and Deviation Management
RIMS and TMF platforms also lack workflows for managing quality issues, deviations, CAPAs and change controls. Again, this means handling these components outside of the system, manually following up for review steps, and uploading necessary documents one by one into the platform.
Audit and Vendor Management
If you’re looking for automated reminders for upcoming audits or simple vendor and supplier tracking (think editable Q-sheets, configurable categories, etc.) you won’t find it in a RIMS or TMF platform.
Quality Metric and Trend Reporting
Continuous improvement is driven by quality data, but you won’t find robust quality metric tracking or data dashboards in RIMS or TMF platforms.
Why would you settle for only some compliance? Quality management is too important – and too complex – to be sidelined as just another feature in a platform built for someone else’s priorities.
RIMS and TMF platforms are important for Regulatory and Clinical teams, but Quality teams need an eQMS to be able to handle all of the factors of compliance. That translates to critical features like:
Managing these tasks outside of an eQMS forces workarounds, creates gaps, and adds risk.
If you want to give your Quality team the foundation they need to keep your organization compliant, audit-ready, and risk adverse, start with the right tool for the job. And if you need help getting the budget you need, check out this guide for more tips on how to convince your C-suite to invest in an eQMS.