- examine the setup, management and consumption of documents supporting a PQS (Pharmaceutical Quality System) according ICH Q10.
- explore the management of lifecycle and control of documents (documentation and records according GMP Chapter 4).
- follow the workflow and approval of the documents in a clear and straight forward manner.
- discuss the wrap-around processes necessary to meet compliance requirements with these controlling type documents, such as Periodic review and Document Distribution.
GxPi works upon the principal that complex issues can be simplified to deliver long term business benefit, better efficiencies and cultural change. We achieve this through a combination of products and services designed specifically for compliance requirements in the life sciences sector. GxPi’s products, x-docs™ and x-train™, provide enterprise grade electronic Document, Content and Compliant training solutions. GxPi’s services cover all aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GDP), qualified person (QP), quality assurance (QA), and validation particularly with Computerised and Information Technology (IT) systems. (For more information, please visit www.gxpi.com )