TrackWise – Maintaining the Validated State Robert Lorence VP, Quality & Compliance Services HighPoint Solutions Tim Mohn Industry Solution Director Sparta Systems Carl Ning Sr. Solutions Consultant Sparta Systems Agenda Introduction Common Challenges Building a Solid Foundation Roles & Responsibilities – Post launch Roundtable Discussion 2 Post Implementation Pitfalls Insufficient, or lack thereof, established management, system, and procedural controls  Maintenance plans / system administration SOPs  Haphazard adherence to change control procedures / system  Disaster Recovery / Contingency Plan  Maintenance / upkeep of validation documentations − − − − − − User requirement specifications Functional requirement specifications System design specifications Validation protocols Risk assessment Training content / material 3 Validation Basics  Key term = intended use. Essentially company defines what the intended use of the software/process is and tests to confirm such  GAMP4 / GAMP5 for guidance (note NOT a regulation)  Every company interprets risk-based approaches differently. There truly isn’t a one-size-fits-all approach  Terminology differs from company to company. Some use IQ/OQ/PQ and others more like UAT terminology  Over 480+ successful implementations 4 Validation Basics PQ scripts IQ Preexisting Processes / SOP’s System URS Configure System Test URS UAT Function OQ Traceability PQ - Verify ‘intended use’ and administration of system Customer Specific Testing MUST be conducted to ensure conformance to their SOPs 5 TrackWise Validation Package includes 1. 2. 3. 4. 5. 6. 7. 8. 9. TrackWise Risk Assessment TrackWise Validation Plan TrackWise Functional Requirements Specification TrackWise Installation Qualification Protocol TrackWise Operational Qualification Protocol TrackWise Traceability Matrix TrackWise Configuration Standard Operating Procedure TrackWise Administration Standard Operating Procedure TrackWise Validation Summary Key point – these documents are starting points for the company and in most cases are updated by the company as part of their validation efforts 6 Roles & Responsibilities Activities Supported By Sparta  Supplier Requalification  Support – Help Desk  Validation Package  Upgrades Activities Supported by TrackWise  Security – user access / system access  Training Management  Change Control − Including IT Change Control (hardware management)  Incident Reporting 7 Roles & Responsibilities Activities Managed by Client  Execution and documentation of periodic review activities  Quality management system and processes  Management of change  Management of IT infrastructure and network  Security – user access and physical security 8 Questions? Thank you 9