Systems, processes and equipment complying current standards
In a pharmaceutical production plant API or with applicable regulations as cGxP’s is mandatory to have the systems and processes validated and that they comply with proper lifecycle in accordance with applicable regulatory and internal requirements. In ASSI our mission is to provide our customers with validation consulting services that provide documented evidence that systems, processes and equipment meet the appropriate requirements to their intended use, and existing regulatory framework.
Therefore we offer not only solutions aimed to systems validations, but also to ensure proper monitoring of the life cycle thereof, thus encompassing the stages of initial design, project (planning, specification, verification, reporting), operation, and the final stage of withdrawal from the system, always keeping in mind the premise of compliance with the regulatory framework cGxP, and ICH Q8, Q9 and Q10 (space design, risk management for quality and assurance activities commensurate) and specific requirements in each case.
- Computerized Systems Validation
- Infrastructure Validation (rooms, warehouses)
- Consulting in design and installation of IT
- Manufacturing and Conditioning processes validation
- Qualification of analytical equipment (and SW support)
- Setting of critical parameters
- Validation of Analytical Methods
- Cleaning processes management
- Services validation
- Climate validation
- Cold chain validation, transport validation: storage facilities, vehicles, routes, isolated boxes, associated Systems.
- Validation in drug distribution transport
- Consulting GMP, GDP and QRM
- Consulting 21 CFR Part11, annex 11 EU, GMP, GAMP5
If you precise advice and you want to take advantage of our expertise we can be your reliable partner and help you in all the services in which we are specialized. We are used to evaluate systems and processes and let you know improvement proposals in compliance with the current regulatory framework applicable.