Testing computer systems for FDA/MHRA compliance. (©2004)

• Record Type: Book
• Further Information: Note: David Stokes.
• Other Names: Stokes, David
• Contents: PURPOSE; ; SCOPE; What 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 TEST; GxP Priority; Software/Hardware Category; Test Rationale and Test Policies; Testing or Verification?; ; THE TEST STRATEGY; Risk Based Rationale; The 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 Specification; Document Evolution; Constraints on the Development of a Test Specification; Constraints on the Testing; Conducting the Tests; Outputs from the Testing; ; RECOMMENDED CONTENT FOR SYSTEM TEST SPECIFICATION(S); Overview; General section; Individual Test Cases; ; GOOD TESTING PRACTICES; Prepare for Success; Common Problems; Testing in the Life Science Industries is Different; Prerequisite Training; An Overview of the Test Programme; Roles and Responsibilities; Managing a Test Programme; Checking Test Scripts in and out; Recording Test Results; To 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 Status; Test Log-On Accounts (User IDs); ; SUPPLIER SYSTEM TEST REPORTS/QUALIFICATION; ; THE USE OF ELECTRONIC TEST MANAGEMENT AND AUTOMATED TEST TOOLS; The Need for Test Tools in the Pharmaceutical Industry; Test Tool Functionality; Electronic Records and Electronic Signature Compliance; The Availability of Suitable Test Tools; Test Script Lifecycle; Incident Lifecycle; Flexibility for Non-GxP Use; Project and Compliance Approach; Testing Test Tools; Test Record Integrity; Features to Look Out For; ; Appendix A - Hardware test specification and testing; Appendix B - Package Configuration Test Specifications and Testing; Appendix 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 Testing; Appendix G - Traceability Matrices; Appendix H - Test Script Templates; Appendix I - Checklists; Appendix J - References and Acknowledgements
• Publisher Details: Boca Raton Storrington, West Sussex : Interpharm/CRC Sue Harwood
• Publication Date: 2004
• Copyright Date: 2004
• Extent: 1 online resource (ix, 125 pages), illustrations
• Subjects: 615.1900685; Pharmaceutical technology -- Automation -- Quality control; Pharmaceutical technology -- Software -- Testing; Computers -- Testing; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Electronic books
• Languages: English
• ISBNs: 0203011333; 9780203011331; 0849321638; 9780849321634
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.