GCP process compliance and quality assurance for clinical trials.
In clinical research and development, we advise on every aspect of compliance management and GCP process optimization. Our work spans audits, the building and adapting of quality management systems for CROs, sponsors and service providers, and process-analysis workshops that prepare you for inspections.
Data quality and integrity - through defined processes.
Clinical research on medicinal products has to protect study participants and safeguard the quality and integrity of its data through appropriate processes - processes that, in turn, must be reviewed for compliance. Whether the sponsor or trial site passes a regulatory inspection comes down to compliant, efficient processes, qualified people and service providers, and a regular review of the requirements.
Because we examine and assess the associated IT systems alongside the processes, every QFINITY audit lowers costs - there is no need for a separate IT audit. At the same time, this interdisciplinary approach gives data integrity the full attention it deserves, in all its facets.
The EMA guideline on computerised systems and ICH E6(R3) set the regulatory bar; the methodology for the system level is set out in the QFINITY-co-authored ISPE GAMP eClinical Good Practice Guide. How we validate the systems behind these processes is covered in Data Integrity of GCP-Relevant Systems.
Audit and compliance types, reviewed across disciplines.
Every audit calls for specialist knowledge - an auditor with a data-management background sees different things in a clinical system than one who comes from the trial site. But anyone who is only a specialist misses the interface where the deficiencies arise. Our auditors are therefore generalists who work their way into a specialty - not specialists who know only their own field.
One audit instead of two.
In clinical research, data quality and inspection readiness rest on both the GCP processes and the computerized systems that support them. We look at both layers in a single pass, treating processes and IT systems not as separate items but as one connected whole.
- One audit report covering processes and the IT systems behind them
- An assessment of data integrity at the process/system interface
- Prioritized actions for inspection preparation
| Aspect | Separate reviews | QFINITY audit |
|---|---|---|
| Scope of review | process and IT system audited separately | process and IT system in a single pass |
| Effort | two audits, two reports, duplicate preparation | one audit, one report - no separate IT audit |
| Data integrity | gaps at the process/IT interface | assessed along ALCOA++ in all its facets |
| Inspection readiness | deficiencies often surface at the interface | trial center and sponsor ready for the audit |
Inspection-ready before the inspection arrives.
Process compliance and quality assurance keep trial centers, laboratories and sponsors ready for the audit. How well this holds up in practice is shown by our case study Investigator Notification System - vendor audit included, validated end to end and signed off with no major deficiencies.
Frequently asked questions about GCP compliance and quality assurance.
ICH E6(R3) lets the sponsor delegate tasks to a CRO - but responsibility for quality and data integrity stays with the sponsor. We put that into practice as risk-based oversight: a vendor/supplier qualification audit before contracting, and targeted audits along the critical processes and the systems behind them - rather than retracing the CRO's work step by step.
Data integrity lives at the interface between process and IT: eCRF, eTMF and systems for randomization and trial supply management (IRT/RTSM) carry the GCP-relevant data. We assess these systems in the same pass as the processes, so deficiencies at the interface don't slip through and a separate IT audit becomes unnecessary. How the systems themselves are validated is covered in Data Integrity of GCP-Relevant Systems.
A GCP audit reviews trial sites and sponsor processes for process adherence and compliance with Good Clinical Practice. A GCLP audit focuses on the clinical laboratories that analyze study samples, reviewing them against Good Clinical Laboratory Practice - the bridging standard between GCP and GLP for data quality in the lab. Both can be part of the same audit program.
A mock audit simulates the regulatory inspection in advance - it prepares a trial site or sponsor for a specific, upcoming inspection. An internal audit is an ongoing quality assurance activity within your own QMS, reviewing your GCP processes and systems on a regular cycle, independent of any specific inspection date.
Compliance needs a foundation.
Inspection-ready before the regulators arrive.
We plan the right audit program with you - Vendor Qualification, GCP and GCLP audits, mock audits, or QMS build-out - and review your processes and IT systems in a single pass. The first call is free and takes about 30 minutes.
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