Amjoco was created by Ian Gaudan, a highly qualified IT professional with over 20 years experience of designing implementing and validating information systems to meet GAMP, FDA, EMA and MHRA regulatory requirements, particularly 21 CFR Part 11 and Annex 11. Amjoco works closely with QA professionals to ensure that both client and regulatory needs are met in full.
Our goal and passion are to meet the needs of Pharmaceutical and life science companies globally for a more pragmatic approach to information systems design, validation and verification.
Among not only smaller companies, but also their much bigger peers, Ian has repeatedly come across frustration that often systems design, integration and validation does not meet users’ needs. In founding Amjoco he is addressing this burning need.
Amjoco is already working for clients in Europe and the USA where its pragmatic approach is deeply appreciated by its clients. It operates to best practice in IT systems development, following current industry and regulatory guidelines. Specifically, Amjoco supports its clients through the entire Systems Development Lifecycle (SDLC).
Let us take the strain so you don’t get the pain.
Amjoco’s services come under three headings
Computer Systems Validation
IT Project Management
Training in Computer Systems Validation
Ian Gaudan is an experienced IT professional who holds an Honours degree (BSc) in Computer Science and a Master’s degree (MSc) in Advanced Manufacturing Systems and Technology. His early career was spent in IT consultancy in the analysis, design, development and validation of bespoke software systems in a GAMP environment.
He has worked as Head of Information Systems and Validation in a number of environments, including pharmaceutical manufacturing, supply chain management and research and development companies. He has operated within the client side, contract clinical services and specialist IT consultancy. He has led many major computer system projects which have included multiple bespoke development and systems integration projects, liaising with both internal and external Subject Matter Experts (SMEs), IT, QA and Validation professionals.
Ian has developed particular skills in the training and mentoring of staff in Computer Systems Validation, in particular the execution of formal testing and the Change Control Process. He is an expert in the formulation and delivery of corporate validation methodologies and has considerable experience of the change management process, implementing and integrating new systems.