Engineering & ASTM E2500 deployment for a biopharmaceutical group
Life Sciences Industries are faced with more restrictive regulatory compliance every day, and also with growing demand for high quality products, reduced time-to-market and the need for robust cost controls, while keeping their focus on public health.
Assystem Care offers consulting services to assist these organizations throughout the entire industrial life cycle.
Based on an in-depth understanding of customer challenges, needs and expectations, our team develops customized offers that are deployed using best-in-class methodologies and tools to achieve a meaningful result.
Apollo Maturity™ Services is a suite of modules that provides a benchmark diagnosis of the maturity rating of our client's engineering and its operational & quality systems. It also assists them in developing strategies that leverage continuous improvement techniques in order to increase the performance and compliance rating of these systems.
Three core elements of Apollo Maturity™ can be combined or used separately:
- “Intelligence” includes industry and regulatory benchmarks, and quality data analysis using state-of-the-art algorithms supported by an innovative Knowledge Management platform.
- “Diagnostics” is a maturity improvement model developed specifically for the Life Sciences Industries, to assess the compliance and performance of practices and identify improvement roadmaps.
- “Solutions” supports organisations though an improvement roadmap using pre-defined process blue-prints, training material and monitoring tools to ensure the success of the project.
Public health and regulatory compliance have always been the main forces driving the pharmaceutical industry. In recent years, the ICH* guides have been imposing a new quality approach, and pushing forward all the regulatory benchmarks. The development of a control strategy and quality process management enable to optimise and monitor production for enhanced patient risk control.
Optimising the management of operational quality processes, preparing your inspections, and deploying quality risk controls throughout your processes are just a few of the ways that Assystem Care can help you to upgrade your quality system by combining industrial performance, quality and regulatory compliance.
*ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ATLAS Solutions backs these projects and is committed to supporting customers to achieve their expected S.M.A.R.T. results. ATLAS performs a detailed understanding of needs in order to define a clear definition of the scope and deliverables.
ATLAS Solutions deploys step-by-step best practice standards that are tailored to client needs:
- Using best-in-class project management methodologies and tools, such as the stage-gate process and Key Performance Indicators
- Identifying and onboarding the right resources at each stage
- Establishing the most appropriate monitoring and reporting structures to assess progress and make decisions to address deviations
- Accessing at any time our knowledge management platform to introduce best practices and accelerate competency development & project timelines
- Performing a knowledge management review at the project closure, and getting customer satisfaction feedback to build a virtuous circle
Presented as an alternative to traditional commissioning and qualification phases, with the prospects of Appendix 15 adding further impetus, the ASTM E2500 process offers fantastic gains: reduced cost and lead times, and a refocused and streamlined approach to public safety.
Benefiting from a wealth of feedback acquired through partnerships with major pharmaceutical companies who've been working in this area for many years, and from its unique methodological expertise, Assystem Care can assist you in this innovative new approach to reap all the benefits while avoiding pitfalls.
Confidence in the conformity of processes goes hand in hand with firm regulatory data control. This is the basis for the Data Integrity concept, which defines under what conditions the data and critical information are considered to be "authentic, complete and integrated throughout their life cycle."
This is also the driving force for regulatory agencies, which now treat the subject with a "process and data" approach that goes well beyond a simple "system-based" approach. Assystem Care can help you, both for your investments and your existing systems, transition from the CSV (Computerized System Validation) approach to the Data Integrity approach.
Assystem first gained experience working on projects for industrial facilities subject to regulatory requirements. The idea is quite simple: it's during the commissioning of a facility that the success of an investment project must be ensured.
For the Life Sciences Industry, Assystem Care has developed a continuous process called Commissioning Qualification Validation (CQV). Our top priority is to provide the necessary assistance to both the design office and the end user to successfully complete each stage with optimised costs and lead times, while complying with all pharmaceutical regulations. From the URS (User Requirement Specification) through to operational procedures and the maintaining of qualifications, we offer time-tested solutions that will increase the reliability of your projects, reduce the time-to-market, and make your investments more efficient.
The Life Sciences Industry is increasingly using automated information systems: digital instruments, process Instrumentation & Controls, robotics, etc., but also systems and databases for a wide variety of applications: control and R&D laboratories, production, logistics, quality, regulatory matters, pharmacovigilance, support services, data sciences, etc.
For all these systems, CSV (Computerized System Validation) encompasses all the activities required to validate an information system for regulated activities throughout its life cycle. The CSV approach offered by Assystem Care will help you strike the right balance between industrial needs and regulatory requirements by incorporating data and system traceability and security at each stage of their life cycle.