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.
What is RIMS software?
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:
- Track submission timelines
- Catalogue submission content
- Log and track emails/letters from regulatory bodies
- Monitor regulatory commitments
- Set up alerts for key regulatory milestones
What is TMF software?
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:
- Store essential clinical trial documents for GCP compliance
- Track version history for trial documents
- Document a record of trial conduct and oversight
- Maintain investigator brochures, ICFs, protocols, etc.
Can RIMS and TMF be used for quality management activities?
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:
Quality functions that are possible in RIMS and TMF
Store quality-related documents, like SOPs, forms, etc.
- You can: Upload and archive quality documents.
- You can’t: Implement document control workflows that automatically require reviews, approvals, document retirement, training etc.
Track document versions
- You can: Manually retire a document and log which version of a document is current.
- You can’t: Automatically enforce effective dates or approval hierarchies for true version control.
Control access with user permissions
- You can: Restrict who can see and/or edit certain documents.
- You can’t: Get granular with user permissions in most platforms, forcing you to choose “all or nothing” when it comes to access.
Quality functions that are not possible in RIMS and TMF
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.
Quality teams need an eQMS, not an all-in-one eClinical solution
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:
- Enforcing document control with automated workflows for approvals, effective dates, and training assignments.
- Managing and linking deviations, CAPAs, and change controls.
- Tracking training compliance company-wide — with audit-ready records you can pull at a moment’s notice.
- Maintaining vendor and supplier oversight in one place.
- Monitoring trends and metrics to fuel continuous improvement.
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.