EMA
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EMA Data Integrity for GMP and GDP Q&A, 8/16
August, 2106, EMA publication answering 23 questions related to Data Integrity. Includes data risk assessment, security, data review, and supplier controls.
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EMA E6(R2): Guideline for Good Clinical Practice, 7/15
July, 2015 consensus draft of ICH E6(R2) for consultation. E6(R2) contains updated GCP requirements for system validation, audit trails, security, and quality assurance SOPs.
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EMA Classification and Analysis of the GCP Inspection Findings 2000-2012
In December, 2014, the EMA (European Medicines Agency) published this analysis for the 398 EMA GCP (Good Clinical Practice) inspections conducted in the years 2000-2012.
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EMA Reflection Paper on Risk Based Quality Management in Clinical Trials, 11/13
This 2013 EMA Reflection Paper supports GCP principles by recommending a systematic, risk-based approach to quality management of clinical trials.
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EMA Reflection Paper on GCP for Trial Master Files, paper or electronic (draft), 12/12
The EMA drafted this reflection paper to set the requirements for Trial Master Files (TMF) to facilitate trial management, GCP compliance, and inspections.
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EMA Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples, 2/12
The European Medicines Agency (EMA) published this guidance. It was adopted by the Good Clinical Practices (GSP) Inspectors Working group on February 28, 2012.
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EMA Annex 11 Computerised Systems FAQ Q&A, 2/11
The EMA published answers to frequently asked Annex 11 questions. The EC’s new version of Annex 11, Computerised Systems, went into effect on June 30, 2011.ﾠ
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EMA Reflection Paper on Expectations for Electronic Source Data & Data Transcribed to Data Collection Tools in Clinical Trials, 8/10
This reflection paper outlines GCP inspectors’ expectations for computer system topics such as validation, SOPs, audit trails, backups, security, user training, and record archival.
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EMEA Procedure For Conducting GCP Inspections Requested by the EMEA: Annex III Computer Systems, 11/07
This document recommends using the PIC/S publication Guidance on Good Practices for Computerised Systems in “GxP” Environments when performing inspections. ﾠ
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