Follow us on LinkedIn

Events

05.11.2019

ADEODATA AT CPhI WORLDWIDE 2019

Adeodata will participate to CPhI Worldwide 2019 in Frankfurt, the largest pharmaceutical event in the world.

+ info
11.01.2019

ADEODATA DAY 2018

The Adeodata annual meeting to share the goals of 2018 and celebrate.

+ info
20.03.2018

PAPERLESS LAB ACADEMY 2018

Baveno (VB), Grand Hotel Dino – 2018, March 20-21th

 

Great success for the sixth edition of Paperless Lab Academy (PLA2018), one of the best European convention about Lab Automation.

+ info
12.01.2018

ADEODATA DAY

2018, January 12th – ComoNExt, Lomazzo


The new year started with the usual Adeodata Day.

+ info
05.10.2017

QC PHARMA DAY

2017, October 7th – Hilton Hotel, Milan

 

Great success for the first QC Pharma Day organized by Quality Systems, on 2017, October 7th in Milan.

+ info
 
01.01.2011

EU Annex 11

GMP Europee (Good Manufacturing Practice) – January 2011

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

Electronic Records Electronic Signatures

 

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

Read more: Read an introduction (in Italian)

 

+ info
..

Publications

 


 

EU Annex 11


GMP Europee (Good Manufacturing Practice) – January 2011

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

 

The new regulations about computerized systems became law on 2011, June 30th. At the same time, even the Chapter n. 4 of the above mentioned European GMP (about documentation) was updated, both to make it congruent with the new Annex 11 and to introduce new subjects.

 

Read more: read the article about the EU Annex 11 update

 


 

21 CFR PART 11

Electronic Records Electronic Signatures

 

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

Read more: Read an introduction (in Italian)


FDA (Food and Drug Administration) – August 2003

FDA recalled some guidelines for the implementation of the 21 CFR Part 11 on electronical records and signatures for pharmaceutical companies and  substituted them with a new version of the 21 CFR Part 11.

This revision is less restrictive and is focused to facilitate the introduction of new technologies in the pharmaceutical industry.

For example, in hybrid systems, where data are collected both in hardcopy and electronic archive, the application of 21 CFR Part 11 is not mandatory anymore.

However, it’s important to be cautious: FDA explicitly when and where it will be discretional in verifying the conformity to 21 CFR Part 11 regulations.

 

Read more: read an article about the new interpretation of 21 CFR Part 11

 


 

GAMP

Good Automated Manufacturing Practice


These are the reference guidelines for pharma CPU systems validation.

The last major revision (GAMP5) was released in February 2008.

 

Read more: read the introduction to GAMP3 (in Italian)

Read more: read the introduction to GAMP4 (in Italian)


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

© 2017 Adeodata. All rights reserved.

..

Designed and developed by Carrara Communication