Validation
Pragmatic, cost effective and timely, risk based approach to CSV
Amjoco specializes in delivering IT project management, computer systems validation and training for the global pharmaceutical, biopharmaceutical, contract research, life science, medical device and regulated healthcare industries.
The Amjoco Difference
What makes us different is that we offer a more human and less burdensome approach to validation, compliance and project management. We listen to you and your needs and then we provide a pragmatic response that can be delivered in a way that meets the needs of both IT and non IT professionals. We know that you have to live with the procedures, processes and systems we leave you with.
Amjoco’s founder, Ian Gaudan, has specialised in requirements gathering, design and delivery of compliant, validated computer systems for over 20 years. He has worked on GLP, GMP, GCP, and GDP regulated systems, often working with non-IT specialists in clinical, development and research roles. Usually within a GAMP® framework. As one who has been both contractor and client, he offers a unique perspective on systems development, delivery, integration and validation. He also has extensive experience of training staff in system validation, verification and compliance procedures and techniques.
Leaner, Smarter, Better
We call our approach ‘leaner, smarter, better’. As regulatory authorities around the world are increasingly applying a risk based approach to software validation and verification, so there is now a greater need for leaner, smarter and better approaches to delivering that compliance. Our leaner approach means pragmatically delivering you a practical solution. It recognises that the perfect can be the enemy of the good. We also aim to make sure that your systems and procedures will pass the types of audit your company will have. A customer will always set the bar higher than a regulatory authority. That’s the smarter approach. And lastly, we offer excellent value for money, that’s the better approach
Experience
Amjoco offers 20 plus years’ experience in regulated IT. With expertise in both R&D and GMP manufacturing systems, usually under GAMP® guidelines. Amjoco can take you through the entire process, from requirements gathering and design, through installation, operation and performance qualification (IQ, OQ, and PQ) to handover and ongoing support and maintenance. We have in-depth knowledge of regulatory authority requirements including FDA, EMA, and MHRA and in particular 21 CFR Part 11 and Annex 11.
End to End Computer Systems Validation and IT Project Management
You can rely on Amjoco to take you through the entire IT system lifecycle from planning, requirements gathering, project design, vendor choice, implementation and finally systems validation and verification. Amjoco’s approach is pragmatic, communicative, and totally committed to delivering beyond your expectations.