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Computerised Systems: A Summary of 2016 MHRA Inspections

The Medicines and Healthcare products Regulatory Agency (MHRA) has a responsibility to protect public health by ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. Each year, they conduct

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Is My Audit Trail Regulatory Compliant?

Operating a laboratory within regulatory requirements can be a challenge.  The wording of regulations is typically cryptic, and there’s always room for different interpretations.  Audit trails are an important factor for compliance because

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GxP Project Management Made Simple

GxP compliance in the pharmaceutical industry is a hot topic. With increasing numbers of drugs coming onto the worldwide market, it is important for pharmaceutical companies to make sure they operate within industry guidelines from development to production. Many companies use a Laboratory Information Management System - or LIMS - to facilitate compliance and ensure they have everything in place during regulatory body audits.

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