Together we fill out standard templates taken from my book.
Projects are typically completed in one-third the time of any other approach.
Validation generally requires support from various functions and levels within the organisation e.g.
scientists involved in using a system, system owner, quality assurance and if the system is networked, the IT department staff responsible for maintaining the server etc.
The users must have the confidence in a system above all others, otherwise your investment will be wasted.
Virtually all equipment used in laboratory’s, clinical R&D or in production environments are classified as computerised systems.
We staff projects based on required expertise and scope, providing the most efficient and cost effective CSV services possible.
Computer validation must provide confidence in the system first and foremost to management and the users, secondly to an internal quality audit and thirdly to an external inspector.
Inspectors only audit an organisation on a periodic basis; all others work in the organisation and use its computerised systems daily.
We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical, risk-based approach to CSV.
By verifying the controlled development and implementation of computer systems, we can help our clients ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and ultimately protect patient safety.