Installation Qualification
Documented verification that equipment and systems are installed correctly, to specification and in the qualified environment.
EquipmentUtilitiesAs-Built
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Validation & Qualification
Complete lifecycle support from protocol development through execution and reporting for equipment, processes and computerised systems.
IQ · OQ · PQ · PV · CV · CSV
21 CFR Part 11 / Annex 11
Protocols & Reports
Overview
Evidence That Your Process Does What You Claim
Validation is not a document exercise — it is the evidence that your equipment, process and systems perform reproducibly within defined limits. We build that evidence from protocol design through execution, deviation handling and final report.
Our consultants write protocols that your team can actually execute on the floor, and reports that hold up when an assessor traces a result back to raw data.
At a Glance
- IQ, OQ and PQ protocol development
- Process and cleaning validation
- CSV to 21 CFR Part 11 / Annex 11
Need this scoped for your facility and target market? A senior consultant will give you a candid read at no cost.
Request a ProposalQualification & Validation Types
Six disciplines covering equipment, process and computerised systems.
Operational Qualification
Testing that the system functions as intended across its full operating range, including alarms, interlocks and limits.
FunctionalityOperating LimitsAlarms
Performance Qualification
Confirmation of real-world process performance under routine production conditions with actual materials.
Routine ConditionsReproducibility
Process Validation
Protocol design, execution across validation batches and comprehensive reporting demonstrating consistent output.
ProtocolsValidation BatchesReports
Cleaning Validation
Demonstration that cleaning procedures reliably prevent cross-contamination and carryover to acceptable limits.
Carryover LimitsSwab & RinseWorst Case
Computer System Validation
Validation of computerised systems for GxP use, covering the full lifecycle and electronic records controls.
21 CFR Part 11Annex 11Audit Traile-Signatures
How We Work
Validation delivered as an integrated lifecycle, not isolated documents.
- Validation Master Plan — A governing plan defining scope, responsibilities, acceptance criteria and the qualification sequence.
- Risk-based approach — Effort concentrated on systems and parameters that genuinely affect product quality and patient safety.
- Execution support — Our consultants on site during execution to resolve deviations as they arise rather than weeks later.
- Periodic review — Re-qualification triggers, change impact assessment and validated-state maintenance.
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