Switzerland +41 91 980 33 18 - info@adeodata.eu / Italy +39 02 967 209 33 - info@adeodata.eu Company Consultancy Product Careers PHARMA 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. + info 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. + info 25.01.2021 IT COMPLIANCE FOR CLINICAL TRIALS AND CROs + info 09.12.2020 CALIBRATIONS AND MAPPING AT -80°C + info 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. + info 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. + info 05.12.2018 GAMP 5: INDUSTRY 4.0 How to ensure compliance of Industry 4.0 solutions to the GMP requirements. + info 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. + info 01.08.2003 21 CFR PART 11 The FDA regulations on electronic critical data and electronical signatures: a reference for the pharma world. + info MEDICAL DEVICE 05.12.2018 GAMP 5: MEDICAL DEVICES A "mature" guideline for the validation of computerized systems in the production of medical devices. + info 01.08.2003 21 CFR PART 11 The FDA regulations on electronic critical data and electronical signatures: a reference for the pharma world. + info Stay tuned! Follow us on Linkedin I authorize the processing of my personal data Adeodata S.r.l. Via E. Mattei, 2 — 22070 Bregnano (CO) Registered office: Via Carducci, 32 — 20123 Milano VAT Nr. 05617310965 REA 1834791 Milano PEC adeodata@pec.it Adeodata SA Via Calgari, 2 — CH 6900 Lugano IDI CHE-112.203.579 Cookies policy | Privacy policy © 2019 Adeodata. All rights reserved. Designed and developed by Carrara Communication