Computer Systems Validation And Cloud Computing

Aim: Computer Systems are established and integral part of management in modern development, validation, manufacturing, logistics, quality and administration for all Life Science organisations such as pharmaceuticals, medical devices, contract laboratories, research organisations (CROs), logistics providers (3 & 4PL) etc. This field of software have been developed to best engineering practices in a quality assured and secure manner to comply with Regulatory and Good Practice (GxP) requirements of the regulators internationally.

Day 1 ► Understanding of how CSV process fits into your software life cycle (SLC); how computer systems are regulated globally (USFDA Part 11 & Pic/s Annex 11 etc; the types of GxP Systems, validation concepts and implementation (risk based approach); industry and regulatory guidance’s on CSV (GAMP-5, FDA etc) and understanding key components and principles of a software quality assurance programs and auditor expectations.

Day 2 ► Vendor Qualification; Cloud Computing (models, risks, benefits and challenges); Develop, test, implement and maintain Saas Based Systems in a cloud environment; consideration of legal issues and best practices for validation test execution, documentation and error handling.

Day 3 ► Hands-on practice creating key validation deliverables, including Requirements, test plan, test scripts and test summary

Download the brochure and registration form.