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15.04.2019

DATA GOVERNANCE: A MATTER OF RESPONSIBILITY AND AWARENESS

Some steps to ensure data security, manage the Audit Trail and ensure the compliance of your systems with Data Integrity.

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07.03.2019

ISSUED THE FDA OFFICIAL GUIDELINE ON DATA INTEGRITY

The FDA's focus on Data integrity does not decrease: 18 questions and answers on the data integrity and governance.

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05.12.2018

GAMP 5: INDUSTRY 4.0

How to ensure compliance of Industry 4.0 solutions to the GMP requirements.

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01.01.2011

EU ANNEX 11

After the draft in 2008, the new Annex 11 to the European GMP for pharma products was published in 2011.

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01.08.2003

21 CFR PART 11

The FDA regulations on electronic critical data and electronical signatures: a reference for the pharma world.

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