Testing Computers Systems for FDA/Mhra Compliance (Hardcover)

PURPOSESCOPEWhat this Guideline Covers When this Guideline is Applicable? Who this Guideline is Intended for? WHY DO WE TEST?Because the Regulators Require Us to... Because the Quality Assurance Department Require Us to... Because We've Always Done it this Way... Because it Saves Money! WHAT TO TESTGxP PrioritySoftware/Hardware CategoryTest Rationale and Test Policies Testing or Verification? THE TEST STRATEGYRisk Based RationaleThe Relationship Between Test Specification(s) Integrating or Omitting the System test Specification(s) The Role of Factory and Site Acceptance Tests Roles and Responsibilities Relationships with Other Lifecycle Phases and Documents (Inputs and Outputs) THE DEVELOPMENT LIFECYCLE OF A TEST SPECIFICATION Recommended Phasing; Interfaces Between and the Dependencies of Activities Milestones in the Process Inputs to the Development of a Test SpecificationDocument EvolutionConstraints on the Development of a Test Specification Constraints on the TestingConducting the Tests Outputs from the Testing RECOMMENDED CONTENT FOR SYSTEM TEST SPECIFICATION(S) OverviewGeneral section Individual Test CasesGOOD TESTING PRACTICES Prepare for Success Common Problems Testing in the Life Science Industries is Different Prerequisite TrainingAn Overview of the Test Programme Roles and Responsibilities Managing a Test Programme Checking Test Scripts in and out Recording Test ResultsTo Sign or Not to Sign The Use of Test Witnesses Capturing Test Evidence (Raw Data) Proceed or Abort? (Test Incident Management) Categorising Test Incidents Impact Assessment Test Execution Status Test Data StatusTest Log-On Accounts (User IDs) SUPPLIER SYSTEM TEST REPORTS/QUALIFICATION THE USE OF ELECTRONIC TEST MANAGEMENT AND AUTOMATED TEST TOOLSThe Need for Test Tools in the Pharmaceutical Industry Test Tool Functionality Electronic Records and Electronic Signature Compliance The Availability of Suitable Test ToolsTest Script Lifecycle Incident Lifecycle Flexibility for Non-GxP Use Project and Compliance ApproachTesting Test Tools Test Record Integrity Features to Look Out For Appendix A - Hardware test specification and testing Appendix B - Package Configuration Test Specifications and TestingAppendix C - Software Module Test Specifications and Testing Appendix D - Software Integration Test Specifications and Testing Appendix E - System Acceptance Test Specifications and Testing Appendix F - Risk Based TestingAppendix G - Traceability Matrices Appendix H - Test Script Templates Appendix I - Checklists Appendix J - References and Acknowledgements