Your quality system deserves better than a blank page.
Auditors do not care how fast you wrote it. They care whether it is defensible, traceable, and complete. Valiqa starts every document at defensible and works up from there.
"I watched good engineers drown in Word templates because nobody told them there was another way."
Every document an auditor will ask for, ready to draft.
Links user requirements to design specifications before anything is procured or fabricated. Vendor criteria, risk-based design review, and regulatory mapping included.
Documentation checks, utility and electrical verification, safety systems and interlocks, firmware recording, and calibration status for every asset.
Challenges parameters at low, nominal, and high values. Alarm and interlock tests, power-failure recovery, access controls, and data integrity checks.
Production-condition protocols with AQL-based sampling plans, pass/fail thresholds, consecutive-run requirements, and environmental monitoring.
Multi-equipment process validation combining CPPs, CQAs, sampling strategies across runs, and process capability analysis.
Stage 1 through 3 process validation documentation, from process design through continued process verification.
GAMP 5 category-aware validation for computerized systems, with Part 11 controls, data integrity requirements, and CSA-aligned critical thinking.
Temperature mapping and thermal qualification protocols with sensor placement rationale, hold-time criteria, and worst-case load definitions.
Process failure mode analysis with severity, occurrence, and detection scoring, RPN ranking, and responsible-party tracking.
Facility-wide validation scope: per-asset IQ/OQ/PQ requirements, criticality classification, scheduling, and revalidation triggers.
From spec sheet to signed page.
Describe the equipment once. Valiqa drafts the full protocol: numbered test steps, acceptance criteria, and the regulatory citation behind every line.
model: MilliQ IX 7010
document: IQ
standards: 21 CFR 820, ISO 13485
Exports to .docx and .xlsx · your templates, your numbering
Generation is the front door. Control is the house.
Drafting the document is the fast part. Valiqa also carries it through signature, execution, deviation, and audit without leaving the platform.
Not sure what validation you need?
Describe your situation and the Valiqa Advisor narrows it down: the documents, protocols, and risk analyses that fit, grounded in the relevant standards. Then it hands off to the generator to draft them, pre-filled.
We just installed a new autoclave. What validation do we need?
For sterilization equipment under QMSR, here is the document set that applies. Ready to hand off to the generator, pre-filled with your equipment details.