SCADA (“Supervisory Control And Data Acquisition” Systems) is the heart of closed and automated systems such as isolators, to produce Advanced Therapy drugs.
Each SCADA platform used in PHARMA must comply with Part 11 and adhere to the principles of data integrity.
Data integrity and compliance under CFR Part 11, known as Part 11 for short, ensures that patients receive health-safe drug treatments. Part 11 is part of the Code of Federal Regulations which establishes FDA record protocols. electronic and electronic signatures and helps define standards that ensure that electronic records and signatures can be considered equivalent to paper records. The ability of an automation software to handle this data must therefore be Part 11 compliant and this depends primarily on the audit trail and digital signature capabilities of the software.
The software must contain an audit trail that records data simultaneously with the execution of actions performed on the system by the operators. Specific user AUDIT profiles are created to be applied to defined projects and it is possible to determine the retention time of the recorded data.
Another aspect of primary importance concerns the integrity of the data which must be attributable, legible, contemporary, original and accurate (also known as ALCOA by many of the large pharmaceutical regulatory bodies). ALCOA has since expanded into ALCOA + to include Available, Durable, Consistent and Comprehensive as a way to fully understand standards for data security and integrity.