The service provides specialized technical support in Commissioning & Qualification (C&Q) and Computer System Validation (CSV) for the pharmaceutical and life sciences industries, ensuring an integrated regulatory compliance approach for facilities, IT infrastructure, and computerized systems.
Service duration is tailored to project complexity, ranging from a few weeks to long-term annual support. It is designed for pharmaceutical, biotechnology, and medical device companies, targeting Quality Assurance (QA), Engineering, IT Compliance, and Operations professionals. The objective is to ensure full compliance with applicable GxP regulations while minimizing operational and inspection risks.
Core activities include
Computer System Validation & IT Compliance:
- supplier oversight during FAT/SAT activities,
- preparation of validation documentation,
- execution of IQ/OQ/PQ protocols,
- development of Standard Operating Procedures (SOPs), and IT infrastructure qualification.
Commissioning & Qualification:
- thermal mapping,
- qualification of equipment, utilities, cleanrooms, and cleaning validation, together with FAT/SAT and IOPQ testing and related documentation.
Assessment & Risk Management:
- compliance assessments,
- risk assessments, and definition of remediation plans.
Training:
- dedicated customer training sessions to strengthen regulatory knowledge and operational capabilities.
Services are delivered through a hybrid model, combining on-site and remote activities, and typically follow three phases: project assessment, documentation, and testing/execution.
All activities are performed by experienced in-house technical specialists organized into multidisciplinary teams with the appropriate level of expertise to meet each client's project requirements.
The fee will be calculated based on the estimated number of days required to provide the services, at an average of €500 per day
The service is specialised in Commissioning & Qualification (C&Q) and Computer System Validation (CSV) for the pharmaceutical and life sciences sectors. We reserve the right to evaluate each request and confirm that we have the appropriate expertise and resources to support the client's specific regulatory and technical requirements. The average daily rate for the service is EUR 500 per consultant/day, although the final price may vary depending on the scope, complexity, duration, and resource requirements of the project.
Access to Infrastructure & R&D Support
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Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project website.
Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.