GMP News - Computer Validation


Be prepared when the GCP inspector asks about Data Integrity

Recently a post in the MHRA blog informed about common findings GCP Inspectors have seen across a number of recent inspections. Read more about Data integrity in Clinical Trials.



Missing Audit Trail Review led to Warning Letter

Chinese manufacturer Zhejiang Ludao Technology received an FDA Warning Letter in February, 2018. During the FDA inspection, the missing Audit Trail Review for the HPLC system was particularly criticised.



ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide

With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.



New MHRA "GxP Data Integrity Guidance and Definitions" published

On 09 March, 2018, the British supervisory agency MHRA published the final version of its guideline on data integrity which has been available as a draft since July 2016. Find out more on a first analysis of the new document "GXP Data Integrity Guidance and Definitions" .



How is the Data Governance System to be implemented in your Company?

The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented? Find out more about the requirements and specifications of the PIC/S guideline for the pharmaceutical Data Governance System.



Regulatory requirements for Audit Trail Reviews

Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain. Read more about the EU, PIC/S and FDA requirements concerning Audit Trails and their reviews.



Data Integrity - Implementation status

Data Integrity deviations are still in the focus of regulators. Nevertheless you will find only general requirements regarding Data Integrity in the GMP Guidelines. More detailed guidelines on Data Integrity are on the way but mostly available as drafts. Get an overview on the current situation and the first implementation steps of Data Integrity activities. 



Data Integrity from an Inspector's Point of View

Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. Read more about an inspector's viewpoint on data integrity.



Important Questions and Answers concerning the Audit Trail Review - Part 2

The webinar "Audit Trail Review" took place in February 2017 - with the goal to address the main elements of data integrity and audit trail reviews. During this webinar more than 50 questions were asked. As time did not allow to answer all of them, the webinar's speaker, Dr Wolfgang Schumacher, provided comprehensive answers later. Find out what questions regarding Audit Trail Review were asked and how they were answered.



Important Questions and Answers concerning the Audit Trail Review

The webinar "Audit Trail Review" took place in February 2017. Its aim was to address the main elements of data integrity and audit trail reviews. Participants have sent more than 50 questions regarding the webinar which the speaker, Dr Wolfgang Schumacher, has partly answered in writing. Learn more about the Webinar Audit Trail Review and about the corresponding questions asked.



Serious FDA Warning Letter issued to European Manufacturer of Sterile Drugs, Part 3 - Data Integrity

As a consequence of significant GMP violations, the American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Read more about the details concerning data integrity issues listed in the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd. 



How important is "Data Governance" for your Company?

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.



Data Integrity - two new documents from PIC/S and EMA

Data Integrity is one of the hottest topics in regulatory activities at the moment. After the publication of draft documents by FDA in April 2016 and MHRA in July 2016, the PIC/S and the European Medicines Agency (EMA) followed on 10 August 2016 with two new documents. Please find here a short overview of the PIC/S draft PI 041-1 "Good practices for data management and integrity in regulated GMP/GDP environments" and the EMA  "Questions and Answers: Good Manufacturing Practices - Data Integrity".



MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft Version for Consultation

In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a "GMP Data Integrity Definitions and Guidance for Industry". The agency has recently published a new version of the Guidance. Please find here a short overview of the new features in the "GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation".



German Company receives FDA Warning Letter for Data Integrity Issues

On 16 May 2016, the FDA issued a Warning Letter to the German APIs manufacturer BBT Biotech GmbH. Read more about the deviations discovered with regard to computerised systems and data integrity.


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