Follow us on LinkedIn

pharma

periodic review
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
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

© 2019 Adeodata. All rights reserved.

Designed and developed by Carrara Communication