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03.05.2022 |
PAPERLESS VALIDATION WITH ADEODATA |
Are you tired of the usual paper-based validation? Do you find it difficult to find meaningful data within validation protocols? There is a solution: paperless validation! |
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01.09.2021 |
PERIODIC REVIEW: WHEN, HOW AND WHY |
The Periodic Review is of fundamental importance to confirm the validation status of computerized systems over time. Not everyone is clear when to do it, what to check, how to document it. Let's do some clarity together. |
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29.07.2021 |
CLINICAL TRIALS: NEW EMA GUIDELINES ON COMPUTERIZED SYSTEMS AND DATA COLLECTION |
A general overview of the requirements presented in the new EMA guideline on the use of computerized systems and on the collection of electronic data in clinical trials. |
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25.01.2021 |
IT COMPLIANCE FOR CLINICAL TRIALS AND CROs |
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09.12.2020 |
CALIBRATIONS AND MAPPING AT -80°C |
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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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