Computerized Systems and Data Integrity Compliance
COETIC has more than 30 years of experience in the selection, auditing, implementation, qualification and validation of computerized systems in regulated industries such as the pharmaceutical industry, biotechnology companies, producers of active pharmaceutical ingredients, manufacturers of medical devices, etc.
- Specifications (RFP/URS)
- Team coaching
- Supplier evaluation and audit
- Design review
- Qualification/validation of on premises and cloud systems
- Project Management Assistance (PMA)
- Data integrity audit and remediation/mitigation plan
- Inspection readiness
- Optimization of your qualification/validation processes
Our expertise
COETIC’s missions consist of training, auditing, expert assessment, assistance in solution selection, and support for our clients in the implementation and validation of processes and procedures with regard to US FDA and EU GMP standards.
Because the human dimension is the most important factor in the success of your projects, COETIC offers a complete range of training courses on the most sensitive subjects such as practical methods of validating computerized systems, analysis and control of regulatory and business risk, supplier auditing, drafting of specifications, etc.
COETIC has 30 years’ experience in training healthcare industry professionals at the Institut de Formation des Industries de Santé (IFIS), the Faculty of Pharmacy Paris 5, and A3P association, and can provide these training courses on an inter- or intra-company basis.
In most cases, an expert’s informed diagnosis can solve functional or technical problems.
An audit can cover various aspects: when applied to a supplier, it highlights their strengths and weaknesses and thus helps to define the applicable project methodology; on a system in the pre-production phase, it ensures that all regulatory requirements have been taken into account and enables approval for production; finally, on your existing processes, the audit reveals potential malfunctions and is an outstanding tool for preventive improvement.
Applying the principles of good practices to computerized systems requires a great deal of experience and discernment in the application of the resulting dispositions. COETIC has particular expertise in this domain and offers its clients its expertise in project management assistance (PMA), particularly in the following stages:
- Master plan: A comprehensive and long-term reflection on a company’s information system that allows it to identify guidelines likely to support its growth in the medium and long term.
- Selecting solutions: the implementation of a master plan requires rigor and consistency in the choice of solutions that will form the backbone of the company’s information system; the definition of clear and shared objectives, the modeling of needs, and the consideration of the company’s technological and human constraints are all conditions for the success of a project. The selection of suppliers is carried out according to a transparent process where all the players can put forward their functional and technical arguments.
- Support in implementation and validation: thanks to efficient project management, COETIC enables the various players involved in a project to be used to their best potential; validation, once integrated into the overall approach of the project, enables coherent dialogue between the various players and allows efforts to be shared and accepted.
Who we are
Since the end of 2024, COETIC has been a Theraxel entity resulting from the cooperation between Jean-Louis JOUVE, IT Compliance and Data Integrity expert, and the managers of Theraxel, who together wanted to offer services 100% dedicated to supporting projects involving IT technologies.
COETIC benefits from the support of the Theraxel experts who are involved throughout the life cycle of a drug or health product in order to provide the necessary business expertise in the implementation of automated and computerized systems at all stages of the manufacturing chain.
Élodie PASTRE and Pierre DEVAUX
THERAXEL managers
Trained as a chemical engineer specializing in industrial analysis, I joined an IT services company as a consultant responsible for the implementation of computerized systems in regulated industries as early as the end of my studies in 1988.
Faced with the constraints of qualification and validation of these systems, I developed a methodology and training dedicated to these aspects; I was thus able to give the first training sessions on the validation of computerized systems within IFIP (now IFIS) in 1992.
With projects implemented for more than 80 clients, I have also supported industrial associations (SFSTP, A3P) on technological and regulatory issues related to computerized systems: cloud outsourcing, serialization, data integrity, artificial intelligence, etc.
Today, I bring all my experience to THERAXEL customers, to give them a competitive edge in CSV and Data Integrity Compliance.
Jean-Louis JOUVE
Expert/référent compliance IT / “Data Integrity”