Managing Data Integrity and Software Integrity in GxP Data Archiving

This presentation considers challenges associated with 1) the regulatory demand for securing data integrity in electronic archiving and 2) the management of digital obsolescence that affects software use for interaction with dynamic electronic data.

Guidance for securing GLP and CLP data integrity, issued by MHRA (2018) and OCED (Doc. 22), have led many companies in the pharmaceutical sector to rethink their data integrity strategy. The increased adoption of digital technologies in operational environments has unquestionably brought improvements and benefits, especially due to the evolution of Software-as-a-Service (SAAS) solutions in the Cloud. Changing from on premise software to SAAS/Cloud solutions has reduced the burden of software installations and upgrades and increased the ease of data production and management. However, use of digital data inherently depends on the availability of software which becomes obsolete within years while data requires retention for decades. Thus, there is an increased need to develop strategies for electronic archiving of native E-data produced in the Cloud and secure software use for both SaaS solutions and retired software from on premise solutions.

We will discuss key questions:

1) How to ensure long term software reliability and compliace with data integrity regulations with the aim to revisit the data for analysis in the future?

2) How to transfer and archive large quantitie of data from GLP and GCP studies?

3) How to ensure availability of SaaS solutions in the future for archiving purposes?

The goal of the discussion is to consider electronic archiving and digital obsolescence from the regulatory, compliance, technical and operations perspective and explore ideas and best practice.