The Quality Policy at Accutest aims at
- Usage of Validated methodology
- Consistently meeting or exceeding the customers expectation for quality and performance of project
- Timely submission of the report for regulatory submission
- Continuous improvement of the system
- Regular personnel training
A well-defined Quality Assurance System meets these requirements consistently.
Our Quality Assurance Team is independent of the Clinical & Analytical teams and we greatly value its opinion. The Quality Assurance team ensures that the conduct of the Clinical study and the generation, documentation and reporting of the data complies with the Protocol, good Clinical Practices, Good Laboratory Practice standards and applicable regulatory requirements.
The Quality System is kept updated by periodic Internal and Vendor Audits and review and updating the SOPs as and when required to update with the current GCP and GLP regulatory guidelines. Proper Change Control System and documentation of the same follow changes in the system.
All steps involved in data management are documented in order to allow step-by –step in-process and retrospective assessment of the quality of the data and the performance of the clinical study. The documentation is facilitated by methods such as use of checklists and forms, details of action taken, dates the individuals responsibilities etc. The team assures that all observations and findings are verified for the credibility of the data and that the conclusions presented are correctly derived from the raw data. The verification process is specified and justified.
The Quality Assurance team ensures that the other staff is trained periodically for the current regulatory guidelines for following the Good Clinical and Good Laboratory Practices.
The QA team is responsible for making the facility, data and documentation available for inspection and audit by the sponsor’s auditor as well as by the regulatory authority (ies).
