GMP News - Computer Validation

19.05.20

EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials

The EMA recently published a notice to sponsors which clarifies the responsibilities in regard to the qualification and validation of computer systems and data Integrity in clinical trials.

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13.05.20

Audit Trail in the Centre of an FDA Warning Letter

The modification and deletion of electronic data must be documented by an audit trail. A missing audit trail led to a Warning Letter to the Indian company Shriram Institute for Industrial Research.

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06.05.20

Remote Access to Critical GxP Systems by Service Providers

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: Must there be regulations for remote access by service providers to GxP-critical systems and what data integrity requirements must they contain?

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08.04.20

How to handle Legacy Systems if no Audit Trail is available or a "User Login" is not possible?

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 7: How to handle Legacy Systems if no audit trail is available or a "user login" is not possible?

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13.11.19

Data Integrity for Analytical Instruments connected to a LIMS via a Middleware

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 6: How can I handle analysis devices that are connected to a LIMS via a middleware? The manufacturer does not allow access to the original data in the automated analyser though.

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19.08.19

Ongoing severe Quality Deficiencies lead to regulatory Action - Part 1

The second Warning Letter within six months reveals fundamental issues in quality management. Learn more about the new FDA warning letter to US company Akorn.

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07.08.19

Regulations concerning the handling and management of data from "small" computerised systems?

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 5: Are regulations necessary for the handling and management of data generated by small systems (e.g.  pH meters, filter integrity testers, etc.)?

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26.06.19

Deletion of Data: Does it have to be regulated in a SOP?

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 4: Does the deletion of data have to be regulated in a SOP?

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08.05.19

Ensuring the data integrity of cloud service providers

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 3: What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?

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04.04.19

Monitoring of Clinical Investigations: FDA´s Q&As on Data Integrity

The FDA provided additional guidance on risk-based monitoring for effective oversight, including Data Integrity. Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.

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13.03.19

Audit Trail Review required before Each Batch Release?

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?

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22.08.18

Data integrity still in the focus of FDA: new warning letter to Japanese API manufacturer

The topics data and data integrity are still in the focus in FDA inspections. Find out more about the details of a warning letter to Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd.

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31.07.18

ICH M11: CeSHarP

In June 2018 the ICH Assembly agreed to work on a new guideline ICH M11 "Clinical electronic Structured Harmonized Protocol (CeSHarP)".

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05.07.18

GCP: FDA Draft on Data Integrity in Clinical Studies

The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of  Electronic Data Files and Statistical Analysis Programs.

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25.04.18

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.

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