The concept of data integrity is nothing new in the life sciences field. A lot of attention has always been paid to the “integrity” of data and to the proper management of documentation. The regulation of life sciences has always been at the forefront in this sector because the quality and effectiveness of final products and their traceability play a fundamental role in the chain of trust.
Nevertheless, the growing use of computer systems for both data generation and storage has complicated the process of ensuring data reliability.
AKKA has the ability to analyze and understand, for each individual customer, the different requirements of the type of production, size and technological sophistication, and propose solutions able to ensure data integrity within Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA) principles for all data generated by production, control and storage systems.
Our approach includes:
A first assessment will be done in order to analyze the system component of the DI project. A complete document will be prepared with advice, cautions and impact risk level of systems. It will then be analyzed in light of CFR 21 part 11 compliance, audit trails, CSV, backup and recovery policies, Quality Management System and SOPs.
DI Action Plan
After the assessment, our consulting team will put a complete action plan in place proposing all the necessary and beneficial activities identified in the assessment phase. It will also include a budget of costs and the timetable needed to reach final DI compliance.
DI Action Plan Support
Consultants and IT technicians will be available to support customers during the action plan implementation offering our multidisciplinary experience for project management and/or activities execution.