Validation & documentation.
Handover documentation is part of the delivery, not an add-on. IQ/OQ/PQ protocols, ALCOA+ compliant weld records, as-built drawings and particle count reports are part of prequalification in this industry - mandatory for pharma GMP, de-facto for semiconductors.
What we document.
- IQ (Installation Qualification) - equipment and material records, weld and pressure protocols
- OQ (Operational Qualification) - function and performance tests against specification
- PQ (Performance Qualification) - data capture during routine operation
- Particle count reports to ISO 14644-3 (cleanroom classification at-rest / in-operation)
- Pressure cascade validation and HEPA leak tests (PAO/DEHS)
- As-built drawings updated to actual installation state
- Material and certificate of analysis (3.1 / 3.2 per EN 10204)
- ALCOA+ compliant data integrity for GMP audits
Which codes we comply with.
| Standard | Application |
|---|---|
| ISO 14644-3 | Particle count, filter integrity, recovery test |
| ISO 14644-1 | Cleanroom classification 1-9 |
| EU GMP Annex 1 | Sterile pharma manufacturing, A/B/C/D |
| EU GMP Annex 15 | Validation master plan |
| ALCOA+ | Data integrity (FDA / EMA) |
| EN 10204 | Material certificates 3.1 / 3.2 |
| VDI 6022 | Hygiene requirements HVAC systems |
Where documentation discipline decides.
Annex 1 retrofit without audit risk
For sterile areas the bottleneck is IQ/OQ documentation, not the mechanical work. We deliver ALCOA+ compliant records that hold up to any MHRA/FDA audit.
Front-end prequalification
Tier-1 EPCs expect particle count per ISO 14644-3 and as-built handover within standard scope. We deliver these documentation packages as an integral part of every cleanroom handover.
Compliance ready
Hyperscale DC operators and research facilities increasingly demand GMP-style documentation. Renka adapts the GMP practice across industries.
Request documentation templates.
Anonymised sample IQ/OQ dossier, as-built sample, ALCOA+ data integrity workflow.