Quality assurance is essential for drug developers and health authorities. We have established all the necessary measures to guarantee totally secure data for our clients. We care about information security and physical protection, which is set up, monitored and optimized in strong interaction with our dedicated QA service.
The PhInc. Modeling quality assurance (QA) unit is managed by one dedicated person who is qualified in GxP quality assurance and is in charge of regulatory monitoring. Our main frames of reference are Good Clinical Practices (GCP), the ICH (International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use) guidelines and all appropriate FDA and EMA guidelines, enabling us to be compliant in whichever domain your development is focused.
Our quality system is, of course, compatible with these regulatory requirements, and also ensures good scientific and technical performance in our R&D activities, through efficient monitoring of our processes (compliance with regulatory requirements, continuous improvement and staff training and follow-up).
We achieve this quality commitment through both our regular internal audits and our quality document management based on the following structure:
We provide you with permanent control and reliability of Information Technology (IT) which insure you the highest level of data security, from study analysis to archiving. We set up:
- Control access permission
- Competence and maintenance of the servers
- Guarantee of the continuity of the activity using a Disaster Recovery Plan (DRP).
PhInc. Modeling benefits from secure buildings through the use of video surveillance, night security guards and entry control into our offices by restricted passes only. Our clients’ data are therefore physically protected.
A policy of validation of computerized systems was implemented as soon as the company was created, following the 21 CFR Part 11 (Code of Federal Regulations) standard (and associated recommendations) and according to the GAMP (Good Automated Manufacturing Practice) guidelines. Thus all of our critical systems are validated and maintained according to the best practices of the industry and current regulatory expectations.