GMP News - Computer Validation

27.08.14

Current FDA's Warning Letters on IT Topics - Part 1: Medical Devices

In cases of serious deviations from the GMP requirements, the US FDA issues Warning Letters to the companies concerned. In some current Warning Letters from 2014, significant GMP deficiencies with regard to IT topics can be found. Read more.

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02.07.14

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations

The FDA published its new Guidance for Industry (GfI) - "Electronic Source Data in Clinical Investigations" in September 2013. The Guidance defines the expectations of the FDA concerning electronic source data generated in the context of clinical trials.  Find out more about this Guidance.

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04.06.14

ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper

When changing from paper-based to computerized systems and processes in the field of Good Clinical Practice (GCP), validating these systems is of critical importance, as inspectors are increasingly focussing on this facet of clinical trials. The ISPE GAMP R&D and Clinical Systems SIG has published a Concept Paper on the application of GAMP 5 validation principles to the GCP field.  Read more here about the Concept Paper

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18.09.13

1997 - 2003 - 2013: Quo vadis 21 CFR 11?

What is the current status concerning US 21 CFR Part 11 - Electronic Records, Electronic Signatures? 16 years after the release of the regulation and 10 years after a period of intensiv discussion you can read a short  summary about the situation today. To read more see here.

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24.04.13

FDA Guidance for Industry on Validation of Blood Establishment Computer Systems

Blood establishments use different and very specific computer systems. The FDA's new Guidance for Industry "Blood Establishment Computer Systems Validation in the User's Facility" published in April 2013 takes into consideration the particularities and validation approaches of such computerised systems. Read more here.

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19.09.12

Japanese Requirements on Computerised Systems

Japaneses GMP requirements are defined by the "Pharmaceuticals and Medical Devices Agency - PMDA". Now, a tentative translation of the requirements on Computerised systems into English is available. Read more.

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15.08.12

FDA Warning Letters relating to Computerised Systems

Problems in connection with computerised systems have also been addressed in two actual FDA Warning Letters. Read more here.

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25.07.12

New Guide for Manufacturers of Stand Alone Software

On June 12, 2012 the Medical Products Agency (Swedish Authority) published an introduction to the so called MEDDEV 2.1/6 Guidelines. Click here to read more.

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25.04.12

Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 4

What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.

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18.04.12

Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 3

What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.

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11.04.12

Questions & Anwers on EU GMP Guideline Annex 11 "Computerised Systems" - chapters 1-2

What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.

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11.05.11

EMA's answers to FAQ on Computerised Systems

The EMA (European Medicines Agency) has just published answers to questions on computerised systems under "Q&A: Good Manufacturing Practices (GMP)". Read more here.

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19.01.11

New EU GMP Guide Annex 11 "Computerised Systems"

In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for GMP regarding IT systems in the pharmaceutical industry. The new version was issued on 3 January 2011 together with the EU GMP Guide Chapter 4 "Documentation". It will become effective on 30 June 2011. Read more.

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15.09.10

The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way

Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.

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14.07.10

FDA Plans New Part 11 Inspections

The topic of electronic records / electronic signatures is again on the FDA's current agenda. On 8 July 2010, the Agency announced that it would increasingly focus on the implementation of the 21 CFR Part 11 requirements during upcoming inspections. Read more here.

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