GxP Testing
This training course will help clients prepare their organization for audits and inspections of computerized systems and electronic data practices to GCP, GLP, GMP, and 21 CFR Part 11 standards. From Top 10 pharmaceutical companies to startup biotech firms, CROs, and software/system suppliers, we have helped clients develop and implement a practical and realistic way to meet regulatory requirements within the parameters of defined business goals.
A practical approach to testing based on GAMP®5 is explained. The principles of testing are defined within this course along with examples of forms and templates that enable the user to successfully test and qualify the systems that they implement.Our approach is based on international standards (ISO, IEEE...) and global regulations and guidelines (EU, FDA, ICH, MHW, OECD). All work produces documents drafted to a standard suitable for management review and every consulting day has a defined work output. Let us help you achieve timely, auditable success in your next computer validation project. Each engagement is customized to client needs and usually includes a combination of the services.
