Industry: Pharmaceuticals
Service: Validation & Compliance
Background A recently acquired division of a Fortune 100 pharmaceutical company became a key research and development facility for the corporation. The Information Technology group was responsible for supporting a large collection of clinical and laboratory systems.
Business Issue The large quantity of cGMP Information Technology projects were stretching the client’s current computer systems validation processes to a breaking point.
The Objective Deliver scalable regulatory compliant validation services by providing sustainable systems analysis and deliverables.
The Solution Arbour Group analyzed the current delivery of validation services and discovered areas of internal conflict within current processes. Gaps in controls and procedures were identified that impacted efficient delivery of compliant validation services.
Arbour provided an analysis to client management with desired outcomes for solution delivery. Engagement outputs included:
- Through interviews and discussions with client personnel, Arbour confirmed the current chatter surrounding personnel discord, overlapping roles, and validation process uncertainty.
- Through interviews with stakeholders and a review of existing SOPs/WIs, Arbour created “as-is” validation process flow swim lane diagrams of current validation and software delivery activities.
- Assessment of needs, opportunities, and priorities for validation service improvement.
- A validation service redesign process map and narrative documentation for client personnel to incorporate into their existing CSV and PM SOPs. Arbour created “to-be” swim lanes to reflect recommended process changes.
- A Responsibility Assignment Matrix (RACI) defining participation by the various roles in completing tasks and deliverables in the validation service design.
- An issues escalation path for resolving issues as improvements were incorporated into client workflows; deliverables included timeframes that drove escalation to provide resolutions.
- A validation charter rubric based on compliance risk and project complexity to be utilized for scoping definition at project initiation.
- An appendix in the Validation Charter for SAP calling out the specific Computer System Validation relevant functions.
- Boiler plate Validation Plan, Protocol and Validation summary report template format and wording that eliminated the “artisan” approach to CSV deliverables that drove inefficiencies.
- Performance measurements for outcomes of redesigned validation service for evaluation of progress toward the desired goal of provision of scalable, sustainable, and compliant validation processes.