PMC and Global Risk Management for pharmaceutical sites
PMC and Global Risk Management for pharmaceutical sites
CHALLENGES
The industrial sector of life sciences is a sustainably growing market, with constant demand driven by a continuous need for more innovative, effective and safer therapies from the public and governments.
With more competition and stringent regulatory requirements (GMP: Good Manufacturing Practises, Pharmacopeia), the industrial landscape requires new solutions.
Life sciences should also take advantage of disruptions offered by digital. These new solutions include new processes, new approaches but also the digitalization of each step of the industrial life cycle, being for new therapies or new industrial investments. Leveraging these with proper risk management and adapted cybersecurity is the new challenge of the industry.
An increasing demand for medication and therapeutic solutions
Faced with the massive emergence of new pathologies, the aging of the population and the increased demand from emerging countries, the healthcare and life science industry has to adapt its business model, organisation as well as industrial network and practices, in order to offer new solutions to a wider range of patients with increased requirements.
Rising to the challenge of regulatory compliance now and in the future
The challenge of complying to ever-changing regulatory requirements is high, at every step of the industrial life cycle, beginning with the startup of a new installation, to the operational organisation. To properly respond to this changing environment, adapted tools, methodologies and expertise are required. Anticipation is key in order to ensure compliance to current and future regulations, but also to optimize and simplify usual over-complex processes.
Controlling your industrial total cost of ownership and your time to market
With more competition for your therapies comes more pressure to deliver on time, if not early. Product launch must happen quickly and your industrial organisation must lead the way. Lead times and cost control are paramount to optimise your operational processes at each step of the product life cycle. Reducing the startup lead times of new installations, increasing flexibility and optimising the cost of ownership by building on operational excellence practices and technical expertise are the cornerstones for bringing the new therapies that patients are waiting for.
Taking advantage of digital while controlling security issues
The digital revolution is like a treasure hunt: find how and where to implement it and the gain will be tremendous. From product development to industrial process improvement or product life cycle management, digitalisation increases the efficiency and compliance to regulations of every task in your organisation. This will be a success if the key challenges of cybersecurity, data integrity and, in general, data life cycle management are tackled adequately.
OUR EXPERTISE IN HEALTHCARE AND LIFE SCIENCES
Assystem supports players in Life Sciences and Health (Medicines & biomedicines, medical devices, diagnostics, agri-agro, fine chemicals, cosmetics, health services).
By combining the complex project engineering and digital engineering skills of Assystem with the compliance, quality and qualification-validation expertises of Assystem Care, we work on your processes, your equipment and your infrastructures, from strategy to operational activities. We take care of your industrial projects throughout their life cycle while optimizing your time-to-market.Our unique advisory offer integrates end-to-end engineering as well as quality and performance management throughout your whole industrial life cycle, with a transverse vision of systems engineering: from conception and engineering to batch release and operations optimisation. Starting from your challenges, our team of experts develops the customised solutions you need based on our methodologies and our own first-of-a-kind smart tools.
Assystem Care is a subsidiary of Assystem dedicated to Health and Life Sciences.
Management of complex projects from engineering studies to commissioning of facilities
Compliance assistance (audit, diagnosis, remediation plans, training, etc.) with proprietary tools
Commissioning Qualification Validation of process and installations (including CSV, Data integrity, ASTM E2500)
Digital transformation (predictive maintenance, data sciences, cybersecurity…)
Our Offers
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Project Management & Engineering -
Compliance, Safety & Security -
Digital & Data
Project Management & Engineering Project Management
- PMO (costing, scheduling, contract, ressources, risks)
- Configuration management
- Contracts & supply chain management
- Construction supervision
- Test & commissioning
- Shut-down supervision
Design
- Conceptual to tender design
- Design Review
System Engineering
- Control over requirements / PBS
- Interface / change management
Industrial Control Systems
- Engineering & design
- V&V / Programming
- MRO
Siting & Permitting
- Siting & impact studies (ESIA, seismological, geological, geotechnical…)
- Permitting
Consulting
- Strategy & organisation
- Lender Technical Advisor
- Readiness assessment
Compliance, Safety & Security Compliance
- Compliance diagnosis
- Improvement / remediation plans
- Commissioning Qualification Validation (CQV)
- Computer System Validation & Data Integrity (CSV/DI)
- Regulatory & operational quality
Safety
- Functional safety
- Dependability
- Nuclear safety
Security
- Industrial cybersecurity
- Security / site protection
Digital & Data Digital System Engineering
- MBSE Services (Model Based Systems Engineering)
- BIM Services
- PLM Services
- Digital test & commissioning
- Digital dismantling
Industrial Data Science
- Document to data
- Master Data Management (MDM)
- Robotic Process Automation (RPA)
- Engineering search engine
- Analytics & Artificial intelligence
Digital Field Service
- Predictive maintenance
- Augmented operator
- Digital twin
Project Control Solutions
- Project delivery model
- PMIS (Project Management Information Systems)
- Complex planning optimisation
Our projects in healthcare and life sciences
expert talks
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