Case Study: Investigator Notification System.
How we helped an international CRO build a bespoke solution for notifying investigators electronically - GxP-compliant, fully integrated and validated using a risk-based approach per GAMP 5.
Manual, error-prone - and no solution on the market.
Notifying investigators about safety-related issues such as SUSARs by hand, day after day, was resource-intensive and error-prone. With no commercial product on the market able to meet the requirements, a bespoke solution was the only way forward. The customer set out to achieve:
- Robust, compliant processes for distributing safety information to investigators electronically
- Process control through metrics and reports
- Electronic signatures for key steps, such as investigators acknowledging receipt of the information
- Integration of the solution into the customer's CTMS
- Risk-based validation per GAMP 5 to meet international requirements
From new processes to a validated solution.
We began by designing new data-entry and distribution processes that reflected pharmacovigilance and clinical-trial regulations alongside the customer's own expectations, then translated them into detailed requirements for development with an external partner. Throughout development and rollout, QFINITY's contribution centered on:
A solution that makes compliance provable.
A key success factor was the close communication between the customer, the external development partner and the validation team. It made an end-to-end validation approach possible - one that ran from the business process all the way through to the development specifications.
The project ran under ICH E6(R2) and followed risk-based validation to GAMP 5 - the methodology that the QFINITY-co-authored ISPE GAMP eClinical Good Practice Guide (2nd edition, 2024) sets out for GCP-relevant systems. Under ICH E6(R3) and the EMA guideline on computerised systems, that is the framework we work in today.
First of its kind - and assessed with no major deficiencies.
An industry first, the bespoke solution was thoroughly assessed and released with no major deficiencies - backed by solid compliance data for customers and regulators alike.
More from our project work.
Custom GxP systems, demonstrably validated.
You need a solution the market doesn't offer - from process design and supplier audit through to risk-based validation per GAMP 5. In a free intro call (about 30 minutes), we map out your requirements, the right validation depth, and the integration points your project needs.
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