eBook: Guide to Archiving and Preserving Essential GCP Records and Data

eBooks Tom Lynam

New eBook providing practical guidance on how to retain essential GCP records and data in line with ICH E6 (R3) and the ALCOA+ principles.

The ALCOA+ principles have now been almost universally adopted by regulators around the world, as the set of principles organisations must adhere to in order to maintain data integrity. Created by the FDA, they are referenced within regulatory publications such as the EU Guidelines on Computerised Systems and ICH E6 (R3). You can even see the language of the principles used explicitly within regulations such as EU CTR.

This new eBook provides guidance on how to navigate this challenging regulatory landscape and to ensure that your essential records are accessible, legible and compliant for +25 years.

Complete the form below to gain access to the eBook.

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Tom Lynam

Tom is the Marketing Director at Arkivum. He joined the business in January 2020 tasked with driving new business growth and building the brand into new sectors such as Pharmaceutical and Life Sciences. He has over 12 years’ experience in several diverse marketing leadership roles across technology and professional services organisations.

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