TrackWise – Maintaining the Validated State

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