GAMP® Data Integrity by Design (Part 1) | Data Integrity by Design is a critical-to-quality initiative for GxP organizations because their business model is driving changes in technology requirements i.e. the globalization of business needs the ability to manage data globally. Additionally, there is an urgent need for fully electronic records replacing manual tasks to eliminate process steps that are potentially subject to human error and therefore comprise points of higher data integrity risk. Essential considerations for DI by Design include:
- A high-level retention strategy, establishing early in the business process design phase how regulated records will be managed and maintained throughout the mandated retention period, and from this the requirements for the supporting computerized systems and electronic archives can be derived (presentation 1).
- An approach for addressing systems which once would have had a simple analogue display but now create electronic records in addition to the display; examples include pH meters, filter integrity testers, portable particle counters etc. The equipment vendors have added electronic records as part of product evolution but created additional data integrity risks which must be managed (presentation 2).
- Without "Vendor 2.0" there cannot be Pharma 4.0. Applications need to meet the regulated company's actual needs, not the vendor's perception of their needs. Vendors' systems and system development lifecycles must be geared to support the regulated company's data lifecycles (presentation 3).
- A validation approach for data integrity technical controls, demonstrating Computer Software Assurance principles as an evolution of the Risk-Based Approach (presentation 4).