A pharma project needed a QA Lead to validate PAS X workflows and production recipes.

The solution needed to be configured, tested, qualified and released in accordance with GxP and internal quality requirements. This called for close control of requirements, risks, design decisions, test materials and validation documentation throughout the project.

The consultant prepared validation plans and strategies, and planned workshops on requirements, risks and design. The work included risk analysis and Design Qualification.

As QA Lead, the consultant reviewed and approved technical documentation, specifications, test materials and procedures. The consultant also supervised MES analysts’ configuration, testing and validation work in both test and production environments.

The assignment also covered change control and coordination with MES, automation, engineering, IT, OT and Quality.

Requirements, risks, tests and approvals were made traceable throughout the project. This supported implementation and subsequent maintenance of the system’s validated state.

AssignmentValidation of PAS X workflows and production recipes.

ResponsibilityQA Lead responsible for reviewing and approving documentation.

ContributionValidation plans, risk assessment, Design Qualification and change control.

A pharmaceutical company was running simultaneous IT and automation projects at several factories. The work needed to take place in live production and be documented in accordance with GxP and the company’s quality requirements.

A senior QA specialist took responsibility for quality assurance of IT and automation solutions, from scope and requirements through testing, approval, changes and documentation.

The consultant worked across production, engineering, automation, IT and Quality. For more than six months, the consultant held overall QA responsibility for IT qualification in an entire department covering several factories.

The work also included data integrity, cold storage validation and preparing IT and automation for operation. The consultant quality-assured approximately 80 Windows and Linux server upgrades, as well as several hardware platforms and IT solutions in live production.

The consultant held QA responsibility for the technical changes and ensured progress, documentation and compliance. The assignment also included developing QA processes and training both new and experienced employees.

AssignmentIT and automation projects in live production.

ResponsibilityQA responsibility for IT qualification across factories.

ContributionRequirements, testing, approvals and quality assurance of server upgrades.

A pharmaceutical manufacturer needed to implement new equipment in a highly regulated production environment. The assignment covered validation, traceability and documentation leading up to regulatory approval.

The client needed a clear connection between user requirements, system design, configuration and testing. Documentation had to be complete, traceable and ready for audit.

The consultant took responsibility for the entire validation process and prepared URS, FS, DS, a Requirement Traceability Matrix, and protocols and reports for IQ, OQ and PQ.

The work took place in a PAS X environment in close collaboration with IT, automation and QA. The consultant planned testing, coordinated validation activities and ensured alignment between system design and regulatory requirements.

The consultant also handled deviations, CAPA, quality notifications, root cause analysis and change control.

The validation work supported regulatory approval of the production equipment. The RTM and test documentation established traceability from user requirements through IQ, OQ and PQ.

AssignmentValidation of new production equipment in a regulated environment.

ResponsibilityPlanning and coordinating the validation process.

ContributionTraceability from user requirements through IQ, OQ and PQ.

A pharmaceutical company needed to coordinate validation activities across global teams and establish consistent execution.

The assignment required management of validation plans, timelines, deliverables and documentation. Quality, IT, validation and other technical functions also needed to work to the same requirements and priorities.

A project manager took responsibility for validation plans, timelines, deliverables and coordination between Quality, IT, validation and technical functions.

The consultant worked closely with global stakeholders and connected system requirements, validation requirements and the project schedule. The work also covered compliance, quality documentation and audit preparation.

Validation plans, deliverables and responsibilities were brought under shared management across the global teams. This established traceability between system requirements, validation requirements, risks and the project schedule.

AssignmentCoordinating validation across global teams.

ResponsibilityProject management of plans, timelines and deliverables.

ContributionConnecting requirements, risks, documentation and the schedule.