22
BIOPHARMA & MANUFACTURING
T Author: CALVIN KIM - Senior Director and Head of IT Quality Systems & Validation at Samsung Biologics
hroughout every project, contract development and manufacturing organisations (CDMOs) will generate an abundance of data while relying on an array of computerised systems. These systems can assist CDMOs in their data management, security enhancement, human error reduction, and efficient xecution of processes. While advances in technology have enhanced and accelerated digitisation of processes, they have also highlighted the many complexities involved in safeguarding data integrity (DI) and maintaining regulatory compliance. Without fully understanding the intended use of the computerised systems utilised and the required mitigation of the associated risks, robust DI controls cannot be established.
If DI cannot be assured, the data cannot be reliable and could result in safety risks, recalls, delays, and denied drug approvals. The importance of DI and the potential risks involved in its absence have necessitated the introduction of guidance and regulations by regulatory bodies globally. WHAT DOES IT MEAN TO BE COMPLIANT WITH THE FDA AND EMA REGULATIONS? Following the initial introduction of DI regulations in the early 1960s by the FDA, there have been consistent updates corresponding to advancements in computerised systems and digitalised solutions over time. FDA’s 21 CFR (Code of Federal Regulations) Part 11 (published in 1997) and EMA’s EudraLex Vol.4 Annex 11 (2011)
Critical
THINKING
The fundamentals of data integrity and why a lack of critical strategic thinking could be affecting the success of implementing the technology properl . MAINTAINING DI WHILE GENERATING AN ABUNDANCE OF DATA Heavily automated equipment and computerised systems used in development and manufacturing processes have led to the generation and management of an abundance of data over a single project. Ensuring DI throughout the project–data lifecycle is essential, meaning data should be complete, consistent, and accurate when they are collected, maintained, backedup, transferred, and analysed throughout its retention time period. With DI, the data generated can be used to make informed decisions to minimise the risk to product quality and patient safety.
provide the key regulatory requirements surrounding electronic records and electronic signatures (ERES), including DI controls and computerised system validation (CSV). FDA, MHRA, and other regulatory guidelines also state that all data created in GxP operations should adhere to the ALCOA principles: ‘Attributable, Legible, Contemporaneous, Original, and Accurate’. Further DI assurance is achieved through following the additional ALCOA+ principles: ‘Complete, Consistent, Enduring, and Available’. Being compliant with the FDA and EMA DI regulations requires CDMOs to establish a