cGMP and Regulatory Updates

Prospective Validation - Deployment Phase On completion of successful testing the system is ready for installation into the final operational environment. During this phase the hardware and software installation is qualified and operational checks are performed. During this phase it is necessary to ensure that arrangements for the use and ongoing systems support and maintenance are either established or that documented plans have been prepared to ensure that these arrangements are in place when the system becomes operational. Data Load Plans, procedures and protocols should define the data load process. All GxP data should be at least double-checked to verify that it has been correctly loaded. Other checks should be put in place as required to verify original GxP data is correct. Statistical sampling can be used to check other data commensurate with the business need to verify data integrity. Rationales justifying sampling regimes should be defined. Automated data load tools should be ...

Prospective Validation - Development Testing Phase The system developer should conduct formal development testing prior to the deployment phase. Development testing includes: • Unit/Module testing. • Integration testing. • Interface testing. • System testing. For small computerised systems it may be appropriate to consolidate or omit some of the above test activities. The justification for consolidation or omission of any test activities should be documented in the validation plan. Testing is carried out according to pre-approved test plans and test cases. Due account should be taken of any test requirements identified by the validation plan, supplier audit and design review. Testing should be conducted against approved specifications. Progression from one test phase to another should not occur without satisfactory resolution of any adverse test results. Testing should be conducted in controlled test environments that should be documented and verified in order to confirm that the hardw...