Commissioning / verification and ASTM E2500...
Commissioning / verification and ASTM E2500 for a new plant
The Health and Life Sciences industries, while having public health as a priority, are confronted on a daily basis with stringent regulatory compliance requirements as well as ever-increasing demands in terms of product quality, time to market and cost control.
Assystem Care offers consulting services to these organisations to help them address the entire industrial life cycle:
After clearly identifying the issues, challenges, needs and expectations of the customer, our teams develop customized offers that are then deployed using proven methodologies and tools to achieve a conclusive result.
Assystem has been able to capitalise on 30 years of experience feedback from players in this sector, enabling it to develop proven proprietary tools for customer projects to carry out compliance and maturity diagnostics, Apollo Maturity™ Services.
It enables the assessment of the regulatory compliance and maturity of a process or organization. The program also helps clients develop strategies based on continuous improvement techniques so that they can increase the level of performance and compliance (maturity) of their systems. Combining data analysis, interviews and digital techniques, it helps to identify hard points and/or to position the client in relation to the benchmark. We offer a progress roadmap giving access to predefined process plans, training materials and monitoring tools to ensure the success of the project.
We have developed a second proprietary tool, AtlasTM Solutions, for remediation projects.
During a remediation plan, whether it is the consequence of a diagnosis or an inspection, its deployment requires both project management tools and in-depth knowledge of the regulations. Based on the best project management approaches (steering and reporting tools, resource and knowledge management), Atlas TM enables our project managers to focus on the technical content of action plans rather than on steering and to support customers in achieving their SMART objectives.
Born in the projects of regulated industrial installations, Assystem has built its expertise around a simple idea: it is through the start-up of the installations that an investment project becomes a winner.
For health and life sciences, Assystem Care has developed a continuous Commissioning Qualification Validation (CQV) process. Our vocation is to accompany both the engineering and the future operator, to make a success of these stages at the best cost, in the shortest possible time and in compliance with pharmaceutical regulations. From URS (User Requirement Specification) to operating procedures and validated maintenance, we have proven proposals that will help you to make your projects more reliable, reduce time-to-market and exploit your investments more efficiently.
The health and life sciences industry is increasingly relying on automated and computerized systems: digital instrumentation, process control, robotization, etc. CSV (Computerized System Validation) refers to all the activities required to validate an information system involved in a regulated activity throughout its life cycle.
Confidence in the conformity of processes is indissociable from the control of regulated data. This is the challenge of the Data Integrity concept, which defines the conditions under which critical data and information are considered to be "authentic, complete and honest throughout their life cycle". It is also the focus of regulatory authorities, who are now approaching this subject with a "process and data" approach. Assystem Care helps you to reconcile industrial and regulatory issues, integrating issues of traceability, integrity and security of data and systems throughout their life cycle.
Patient health and regulatory compliance have always been the primary concerns of health industry (GMP: Good Manufacturing Practises, Pharmacopeia). In recent years, the ICH* guides have imposed a new approach to quality and have led to changes in all regulatory frameworks. The development of the control strategy and the management of quality processes make it possible to optimize and monitor the quality of production and thus increase patient risk control.
To optimize the management of the operational quality processes, to prepare your inspections and to deploy the control of the quality risk in your processes are part of the proposals of Assystem Care to help you in the evolution of your quality system by combining industrial performance, quality and regulatory compliance.
*ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
"The use of digital solutions enhance industrial performance on compliance issues and also when it comes to managing multi-party projects, supervising work and equipment, and providing oversight..."