AquaVal Consulting prepares and manages GMP validation documentation — from URS to OQ — so your PW & WFI systems clear FDA inspections without surprises.
DQDesign QualificationReadyIQInstallation QualificationReadyOQOperational QualificationReadyFATFactory Acceptance TestingReadyTRMTraceability MatrixReadySOPStandard Operating ProceduresReadyCSVCSV DocumentsReady
DQ, FAT, IQ, OQ, TRM, RA, GAP and SOPs are prepared alongside the actual PW/WFI skid — not filled in from a generic template.
Each binder in your validation package is version-controlled, cross-referenced, and ready to hand to an inspector on day one.
AquaVal Consulting specialises in the preparation and management of validation documents for pharmaceutical water systems required in GMP-regulated engineering projects.
We help pharmaceutical manufacturers, engineering contractors and water treatment system providers build robust documentation packages that stand up to regulatory scrutiny — accurate, technically sound, and ready for the auditor. Also provide support for preparing CSV documents.
Every deliverable is prepared to close the gap between what your system does and what regulators expect it to prove.
DQVerifies the system design meets user and regulatory requirements before build.
IQDocuments that equipment is installed correctly, per specification and drawings.
OQConfirms the system operates within defined limits across its full operating range.
FATStructured testing at the vendor site — design, material, instrumentation and performance checks.
DCRControlled, traceable records for every revision across the validation lifecycle.
SOPClear, compliant operating procedures your team can actually follow and audit against.
CSVValidates computerised systems and software used in GMP-regulated processes meet regulatory requirements of 21 CFR Part 11.
URSThe baseline that defines what your system must do — and the yardstick everything traces back to.
TRMLinks every requirement to its test evidence, so nothing is left unproven at inspection.
RAIdentifies, ranks and mitigates risks across the system in line with GMP expectations.
GAPBenchmarks your current documentation against the standards and flags what's missing.
+Additional Support for any other document requirements shall also be provided.Unbiased, vendor-neutral packages prepared purely in your interest.
Scoped to your system, your standards and your inspection timeline.
Mapped to ASME BPE, USP<1231>, EU GMP Annex 1 and ISPE Vol-4.
Deep, hands-on knowledge of pharmaceutical water system validation.
Technically sound documents built to survive an FDA inspection.
A dedicated approach with project support that keeps you on schedule.
Define requirements and analyse gaps against the standards.
Risk-assess the system and build the traceability matrix.
Prepare design qualification and factory acceptance testing.
Document installation and operational qualification requirements.
Deliver SOPs and change records — audit-ready for inspection.
Tell us about your water system and inspection timeline. We'll scope the documentation package your project needs.