Controlled Documents
SOPs, policies, work instructions and templates for relevant GxP-impact activities.
QUALITY
Quality & Compliance
Quality is built into contracted work through controlled procedures, risk-based review, traceability, defined access, documented issue management and validation evidence appropriate to the deliverable.
FRAMEWORK
Quality Management Framework
Risk-Based QC
Review depth selected according to deliverable criticality and agreed validation approach.
Deviations & CAPA
Structured investigation, corrective/preventive actions and follow-up where applicable.
Change Control
Controlled assessment and implementation of process or system changes within scope.
Data Integrity & Traceability
Specifications, versions, issue history and review evidence retained so key decisions can be reconstructed.
Access & Transfer Control
Role-based access and controlled data transfer practices aligned with client and study requirements.
Audit / Qualification Readiness
Preparation, participation and follow-up for client qualification or audit activities within the contracted scope.
Training & Role Clarity
Defined responsibilities, qualification and training records for assigned tasks.
QC
Programming & Output QC
01
Specification
02
Development
03
QC / Validation
04
Issue Resolution
05
Review
06
Final Status
VALIDATION
Validation & Compliance Evidence
Independent QC / Validation Programming
Independent programming or targeted verification for selected critical datasets, derivations and outputs.
CDISC Conformance Review
Pinnacle 21 findings assessed, resolved or documented together with the rationale and package context.
Computerized System Assurance
Support for risk-based system validation/assurance documentation where required by intended use, client procedure and project scope.
Client SOP Alignment
FSP and project teams work within agreed client procedures, systems and governance when that is part of the delivery model.