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 The Computer System Validation department has
been the Pharma Quality Europe core business since our
foundation in 1998 and it has established a history of excellence in terms of
validation services. We can provide our clients with validation strategy tailored
on customer's needs, systems and processes, that meets regulatory expectations
and ensure that quality is designed throughout the whole system life cycle.
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VALIDATION OF:
- Software which is a medical device itself
- Software used as components, parts or accessories of a medical device
- Software used for the production of a medical device
- Software used for the implementation of a quality system in the production of a medical device
CSV OFFERS FULL SUPPORT OF SYSTEM LIFE CYCLE ACTIVITIES & PROJECT MANAGEMENT:
- Supplier procurement support
- Supplier auditing and monitoring
- Supplier validation package development and review
- Global company process mapping and process requirements definition
- Computer system validation policy & procedures deployment
- Computer system inventory management procedures
- Risk analysis & risk management
- Site validation master plan
- Software validation and SDLC documentation preparation and review
- Validation testing: IQ/OQ/PQ protocol definition and execution
- System validation maintenance
- Compliance assessment and remediation plan
- 21 CFR part 11 compliance assessment and remediation plan
- Implementation of infrastructure-related SOPs
- Regulated inspection preparation, mock inspection and shadow room management
- Training related to computer system validation and infrastructure qualification
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allows to demonstrate that the
quality is built into the software product, not relying only on testing to
ensure quality. To this aim, computer system validation must be
addressed throughout the whole system development life cycle from initiation
through development, testing and production use and decommissioning.
One of the
major plus of CSV department is the experience gained in a broad range of
operational conditions within many clients with different needs and size. |
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validation activities are executed by experienced staff with the following skills:
- Knowledge of medical devices related processes
- In-depth understanding of regulatory compliance
- Expertise on information technologies
A combination of these expertise allows to fit
the Regulatory requirements against the Client expectations. |
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