News

ECA establishes new Interest Group on Pharmaceutical IT Compliance

The ECA Foundation has established various working and interest groups concentrating on different topics. To cover IT technologies with regard to international GMP requirements the Foundation now established a new Interest Group on Pharmaceutical IT Compliance.

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New WHO Draft on "Good Data and Record Management"

Data Integrity as a topic has become one of the main focuses of the regulatory authorities. Mid-September, the WHO published a draft guidance for comment on this topic too. Read more about the WHO Draft Guidance on Good Data and Record Management.

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Consequences of the new MHRA Guideline for Excel

In March 2015, the British authority MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). These requirements apply to all electronically stored data - regardless of the technology used for data saved in MS Excel. Learn more about the relevance of the MHRA Guideline for MS Excel.

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Another FDA Warning Letter with Focus on "Data Integrity"

The US FDA has a new focus of their inspections: the review to the integrity of data. A recent Warning Letter from July 2015 shows again a clear focus on the issue of data integrity. Please find more information in the Current FDA Warning Letter regarding Data Integrity.

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The integrity of GMP data - part 2 of the new MHRA blog

In July 2015, the second MHRA blog on the theme of data integrity went live. This time, the focus is on designing systems properly. The ALCOA principles are considered to be very helpful. Read more about the MHRA Good Manufacturing Practice (GMP) Data Integrity blog part 2.

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Integrity of GMP Data - New MHRA Blog!

In June 2015 the MHRA, UK, has started an online blog particularly on data integrity. From their perspective the great misunderstanding is that failures with regard to the integrity of data are only caused by deliberate fraud. Read more about the MHRA Blog on Data Integrity.

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FDA Warning Letter on Data Integrity

The integrity of data is currently in the focus of international authorities. In particular the US FDA issued serious violations in Warning Letters to the companies concerned. Read more about the current complaints in a Warning Letter issued to the API manufacturer VUAB Pharma.

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Track&Trace - IT Implementation ordered by European Pharmaceutical Associations

The "European Medicines Verification Organisation" (EMVO) has developed a model for the practical and cost effective implementation of the system for data storing and has also signed framework agreements with three partners. Find out more about the EMVO model.

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Data Integrity - Indian Government puts EU under pressure

One of the largest scandals with regard to data integrity and data manipulation has been detected by French Inspectors of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) in India. But the government in India will not accept the finding.  Read more about the data integrity and data manipulation issues observed at GVK and the consequences.

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MHRA revises its Guideline on Data Integrity in the short Term

The MHRA revised their Data Integrity Guidance in the short term. Read in this news what the current "GMP data integrity definitions and guidance for industry" requires with regard to the GMP compliant handling of data and records.

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