Pharma Validation & Qualification Services

Kestrel Life Sciences Limited delivers end-to-end validation and qualification across GxP environments—covering computerized systems, instruments, equipment, facilities, utilities, and processes. We blend CSV/CSA best practice with modern AI and Data Integrity (DI) controls to keep you compliant, inspection-ready, and moving faster.

What We Validate & Qualify

  • Computerized Systems (GAMP5/CSA): ERP/MES/LIMS, QMS, eQMS, eTMF, EDMS, bespoke apps, spreadsheets/macros.
  • Laboratory & Manufacturing: Analytical instruments, PLC/SCADA/DCS, PAT, robots, sensors, shop-floor IT/OT.
  • Facilities, Utilities & Process: HVAC, WFI/PW, cleanrooms, autoclaves, sterilizers, compounding, filling/packaging lines.
  • AI-Enabled Systems: Generative and classical ML models, RAG/agentic workflows, model monitoring and change control.

Standards & Regulations We Align To

  • 21 CFR Part 11 (electronic records/signatures)
  • EU Annex 11 (computerised systems)
  • EU Annex 15 (qualification & validation)
  • ISPE GAMP® 5 (Second Edition) / CSA
  • Data Integrity (ALCOA+) across the lifecycle
  • ICH Q8–Q10, Q9 (QRM), PIC/S guidance
  • AI & Digital: ISPE GAMP AI guidance, EMA/FDA positions, and trustworthy/responsible AI frameworks

Our Approach (Practical, Risk-Based, Inspection-Ready)

  • Plan & Scope: Map systems, classify GxP impact, define risk and intended use.
  • Requirements & Design: Clear, testable requirements; supplier leverage where appropriate.
  • Qualification (DQ/IQ/OQ/PQ): Scaled protocols, defensible traceability, right-sized evidence.
  • Testing & Reporting: Requirements-based testing, defect management, validation summary reports.
  • Lifecycle Control: SOPs, training, periodic review, change control, data integrity governance.
  • Supplier & Cloud Assurance: QMS assessment, SLAs, service and security reviews.
  • AI in Scope: Model/system requirements, data/feature lineage, bias and performance checks, documented human-in-the-loop controls, model drift monitoring, and predetermined change plans where applicable.

Data Integrity by Design

We embed ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) into processes, metadata, audit trails, security, and backup/restore—so records stand up to regulators.

Documentation You Receive

  • Validation Plan, Risk Assessments, URS/FS/DS
  • Traceability Matrix, Test Protocols (IQ/OQ/PQ) & Reports
  • Configuration/Release Records, Periodic Review Packs
  • SOPs/Work Instructions, Training Materials
  • AI/DI Addenda: data governance, model documentation, drift/quality dashboards, and change control narratives

Benefits

  • Faster time-to-release with right-sized, risk-based effort
  • Lower compliance overhead via smart re-use and supplier leverage
  • Audit-ready transparency and defendable decision-making
  • Future-proof foundations for AI, cloud, and continuous improvement

How We Work

  1. Discovery → 2) Plan & Risk → 3) Execute & Evidence → 4) Release → 5) Operate & Improve
    Engagements can be turnkey or collaborative with your QA/IT/Engineering teams.

Ready to get compliant—without the drag?

Kestrel Life Sciences Limited can validate and qualify your systems, equipment, and processes to global expectations—while keeping your teams moving.
Contact us to schedule a consultation.