More and more life science companies are implementing automation and software systems to achieve compliance and operational excellence including Electronic Batch Record Systems, Data Historians that capture critical to quality parameters, Lab Information Management Systems, and many more.
The Integrity of the data stored in these systems is a key foundation for Medical Device and Pharmaceutical companies. ALCOA+ is the commonly used acronym for DI – Attributable, Legible, Contemporaneous, Original, Accurate. The additional elements are Complete, Consistent, Enduring & Available.