Our Equipment and Facility Qualification Services
Many service providers execute IQ/OQ/PQ only. We deliver the complete qualification: procurement advisory, URS and DQ, FAT/SAT, installation, operation and performance evidence – and CSV integration for software and lab IT where required. One point of contact, six service areas, optionally an external Validation Manager.
Phase 1 · before purchase
Supplier Selection & Procurement Advisory
Before you invest, we structure requirements, shortlists and evaluation criteria for instruments, skids or production lines – including supplier audit and FAT planning.
Outcome: robust procurement recommendation with documented supplier assessment
- URS draft and technical requirements workshops
- Manufacturer shortlist, demo and reference review
- Supplier qualification and audit preparation
Phase 2 · before purchase
URS, Risk & GxP Assessment
We assess planned equipment against Annex 15, process requirements and Data Integrity – before the purchase contract is signed. Open points are formulated as concrete actions for design or operation.
Outcome: risk-based investment decision with a robust test strategy
- URS, risk analysis and qualification strategy
- Validation Master Plan (VMP) as steering instrument
- Alignment with QA, subject-matter experts and supplier
Phase 3 · design
Design Qualification (DQ)
DQ ensures that design, room layout and automation concept meet the URS – before the facility is delivered or installed. For production lines we coordinate engineering review and interfaces.
Outcome: approved design with traceable URS coverage
- DQ protocol and design review
- Room and utility requirements (HVAC, media)
- FAT/SAT planning with the manufacturer
Phase 4 · installation
FAT, SAT & Installation Qualification (IQ)
We support Factory and Site Acceptance Tests, document on-site installation and verify completeness, wiring, calibration status and interfaces – including lab IT and instrument PCs.
Outcome: demonstrably correct installation per specification and manufacturer requirements
- FAT/SAT protocols and deviation management
- IQ with component list, media and utilities
- Prepare connection to DCS, MES or LIMS
Phase 5 · operation
Operational Qualification (OQ)
OQ demonstrates that equipment functions within the defined operating range: limits, alarms, safety functions and worst-case scenarios are tested on a risk-based approach.
Outcome: documented functional evidence with assessed deviations
- OQ protocols for critical parameters
- Alarm, interlock and safety checks
- Training and handover to end users
Phase 6 · performance
Performance Qualification (PQ)
Under real conditions – with production or representative materials – we prove reproducibility and process capability. PQ is the bridge to subsequent process validation.
Outcome: reproducible performance evidence under routine conditions
- PQ protocols with statistical evaluation where needed
- Process-relevant test materials and worst-case runs
- Qualification summary report (VSR) with release recommendation
Phase 7 · system
CSV, Calibration & Release
Where equipment has software, interfaces or an instrument PC, we validate the CSV integration. Calibration plan, change control and periodic review secure operation after release.
Outcome: released overall system – mechanical, electrical and digital, audit-ready
- CSV for device software, lab IT and interfaces
- Calibration and maintenance concept
- Requalification and inspection readiness
What sets us apart: device, room, automation and software are not qualified in isolation. We run DQ through PQ in one evidence chain – and integrate CSV, IT and project management when the equipment is part of a larger system.
Planning a qualification project – clarify scope and start?
Book an intro callQualification pathfinder
Where is your qualification project today?
Choose your starting point. You receive the right entry route – including references and a direct contact path.
Choose equipment before you commit
URS, risk and supplier assessment before purchase – so FAT, IQ and OQ build on the right instrument.
Lab instrument & equipment
IQ/OQ/PQ for chromatographs, balances, analysers and instrument PCs – including CSV integration where needed.
Production facility & skids
DQ through PQ for production lines, utilities, automation and room qualification per Annex 15.
Retrofit & re-qualification
Qualify existing assets to current standards: gap analysis, closure of gaps and re-qual after change or interval.
Validation Manager & instrument fleet
Central control of due dates, owners and release status for many instruments – instead of isolated solutions.
Qualification end to end means: no handover between engineering, qualification consultant and CSV provider. One team covers URS, DQ, FAT/SAT, IQ/OQ/PQ and software validation where needed – aligned with your Validation Master Plan.
Reference: NanoDrop One including Validation Manager and PCR instrument fleet. Read case story
The four qualification phases: DQ, IQ, OQ, PQ
Annex 15 structures the lifecycle in four consecutive phases. Each phase ends with a signed protocol – the chain forms the qualification dossier.
Design Qualification
Design, room and automation are checked against the URS – before delivery or build. FAT planning starts here.
Installation Qualification
Correct installation, components, wiring and utilities on site. FAT/SAT results feed in.
Operational Qualification
Function within the defined operating range: limits, alarms, safety and worst-case tests.
Performance Qualification
Reproducibility under real conditions with production or representative materials.
Six service areas – one qualification programme
Equipment projects touch QA, engineering, IT and suppliers. That is why we bring all six cube one GmbH service areas into one programme – without media breaks.
Data Integrity Consulting
Pre-purchase URS and DI assessment, audit-trail concepts for device software.
View Data Integrity ›Equipment and Facility Qualification
DQ through PQ for lab instruments, skids and production facilities – core of this page.
View services above ›Computer System Validation (CSV)
Validate device software, lab IT, DCS interfaces and data paths.
View CSV ›IT Administration
Instrument PCs, network, backup and hardening for qualified devices.
View IT Administration ›Project Management
FAT/SAT dates, suppliers, milestones and reporting through go-live.
View Project Management ›Software Development
Interfaces, data converters and automation per GAMP 5 Category 5.
View Software Development ›GxP consulting in five steps
Each step ends with a deliverable you can present in QA review and audit – whether equipment, facility or CSV is in focus.
Planning
We clarify scope, roles, risks and regulatory context and anchor them in a robust project or validation plan.
Approved plan with scope, responsibilities and milestone logic.
Specification
Requirements, design decisions and acceptance criteria are documented before implementation or configuration begins.
Released specification package with traceable requirements.
Implementation
Configuration, installation or rollout proceeds with change control and evidence captured in parallel.
Executed change records and build artefacts aligned to the specification.
Qualification
Risk-based testing, deviation handling and review demonstrate that equipment and systems meet intended use.
Completed test evidence with assessed deviations.
Release
Formal approval, handover to operations and archival close the loop for routine GxP operation.
Release report and audit-ready documentation package.
Clarify scope and next steps?
Book an intro callWhat is Equipment and Facility Qualification?
Qualification is the formal process of confirming that equipment, facilities and systems are correctly installed, operate as intended and produce the expected results. It is a prerequisite for process validation and therefore for the market authorisation of products.
The basis in the pharmaceutical industry is the EU GMP Guideline Annex 15 (Qualification and Validation). Supplementary requirements include Annex 11 for computerised systems, FDA Process Validation Guidance and ICH Q7 for APIs.
A complete qualification protects against audit findings, rework and production downtime. Coordinating supplier, engineering and evidence from one source saves time to release.
Qualification lifecycle per V-model
Specification on the left, evidence on the right – the classic Annex 15 approach. For COTS equipment we use manufacturer protocols where they are robust.
Audit takeaway: URS and DQ define what should be delivered – IQ, OQ and PQ prove it works on site. The VSR closes the qualification dossier.
Specialised services in the qualification context
For complete production lines along the automation pyramid, see Production Plant Qualification. We validate Excel-based GxP tools on the Excelsheet Validation page. An external Validation Manager is available as a steering function.
After release: securing operation
Release is the start of GxP operation. Calibration and change control keep equipment in a qualified state long term.
Calibration & maintenance
- Calibration plan and tracking of due dates
- Preventive maintenance in the validated environment
- Trend analysis and deviation escalation
Change Control & re-qual
- Impact assessment for changes to equipment or rooms
- Requalification after repair, relocation or upgrade
- Periodic review and inspection readiness
