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Compliance Monitors: 8 steps to understanding the MHRA’s intriguing new pilot programme.

Compliance Monitors: 8 steps to understanding the MHRA’s intriguing new pilot programme.

A blog post by the MHRA (Medicines and Healthcare products Regulatory Agency) on 11 March 2022 rang in the news of a brand-new programme they intend to launch in April 2022: The Compliance Monitor (CM) pilot programme. *UPDATE* Paradigm Shift can support with...
Quality Management System and Standard Operating Procedures

Quality Management System and Standard Operating Procedures

Quality Management System A Quality Management System (QMS) is defined as: “The organisational structure, procedures, processes and resources needed to implement quality management.” The backbone of the QMS is your Standard Operating Procedures (SOPs),...
Approval of Suppliers and Customers in GDP

Approval of Suppliers and Customers in GDP

Approval of Suppliers and Customers Approving suppliers and customers is one of the key requirements of GDP, and with the 2013/C 343/01 update to the EU guidance it should now be standard for you and your team to gather more information on every company you work with....