How are batches managed?
How can cloud computing be used in a highly regulated environment?
Nine vendors and one end user recently conducted pilot tests to develop, evaluate, and validate a new serialization standard, PSS 1.0, officially released in November 2017. This group, known as the Open Serialization Communication Standard Group (Open-SCS), advocates that PSS 1.0 minimizes customization of plant-to-enterprise interfaces (Levels 3 and 4), thereby shortening the integration process by months and improving scalability and repeatability.Read More
The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of: Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction
A robust data integrity program ensures data integrity across this entire life cycle. Such a program would include a risk-based analysis of all data flows to identify, assess, mitigate, and communicate potential data integrity issues. Systems supporting the data integrity should be validated for their intended use, and boundaries for the data should be identified. Throughout the data process, data must be secured from modification or deletion by unauthorized personnel, and changes to the data must be captured in audit trails or through appropriate procedures.Read More