European Pharmaceutical Review

MARCH 12, 2024

With the proliferation of digital tools, systems and platforms, it has become difficult to ensure the integrity of data throughout its lifecycle. This challenge is further compounded by the evolving regulatory landscape, requiring stringent data integrity requirements to be met.

Documentation

GMPSOP

OCTOBER 28, 2023

. – Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. – Archive records so that they are protected, secured, and easily retrievable.

Documentation

GMPSOP

APRIL 3, 2023

Data management policy : This policy governs activities for data entry, storage, and retrieval to ensure the integrity of laboratory results. Record keeping policy : this policy outlines procedures for documenting laboratory activities, including data, results, and observations.

Documentation

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc.

Documentation