Industry
Medical devices, pharmaceuticals, healthcare: regulations require full traceability and validated information systems.
Medical devices, pharmaceuticals and healthcare share a major constraint: demonstrating at all times that products and processes are compliant.
Information systems must be validated, trace every change and every batch, and remain under control as they evolve.
The topics that come up most often in our discussions with manufacturers in the sector.
Documenting design and manufacturing to meet the requirements of health authorities.
Demonstrating that computerised systems do what is expected, and keeping it that way over time.
Tracking batches and serial numbers, from raw material to delivered product.
Controlling the impact of each change on products and documentation.
We work on PLM (design history files, changes), MES (electronic batch records, traceability), ERP and ALM.
Our consultants provide consulting, business-side project assistance (AMOA), integration and application maintenance and training.
We build validation and change control activities into our schedules from the outset. Our consultants work with your quality teams, who remain responsible for compliance, so that every system change is documented and justified.
Each assignment begins with understanding your processes and the constraints of the life sciences sector. We then propose a realistic roadmap and support you as needed: one-off expertise, project support, or reinforcement of your teams and those of your integrator. Our consultants combine business and technical expertise and are proficient in the leading solutions on the market.
Some of the clients in the sector that our consultants have worked with.
Yes. We build validation activities (specifications, testing, documentation) into our projects, working with your quality teams, who remain responsible for compliance.
The PLM and MES solutions on the market, including BIOVIA and Dassault Systèmes’ 3DEXPERIENCE.
Yes: upgrades, enhancements and application maintenance, in line with your organisation’s change control procedures.
Speak with an expert to scope your needs, with no obligation.
contact@cnext-consulting.fr
La Turbine, 32 boulevard du Port
CS20001, 95015 Cergy-Pontoise Cedex