Valiqa generates audit-defensible IQ/OQ/PQ protocols with regulatory traceability, Part 11 audit trails, and acceptance criteria that survive FDA and ISO audits. Built by a validation engineer who watched teams drown in Word templates because nobody told them there was another way.
Each mode is purpose-built for a specific validation document type.
Verifies that equipment is received, installed, and configured according to manufacturer specifications and site requirements. Covers documentation checks, utility connections, safety systems, and calibration status.
Auditors do not care how fast you wrote it. They care whether it is defensible, traceable, and complete.
A real IQ protocol, not a template. Equipment-specific test steps with acceptance criteria and regulatory references.
Verify that the manufacturer's installation manual, operating manual, and certificate of conformance are present and match the purchase order specifications.
Record and verify equipment nameplate data: manufacturer, model number, serial number, electrical rating, and manufacturing date.
Verify feed water supply connection: pressure within 20-80 psi, hardness below 15 gpg, chlorine below 1.0 ppm. Record inlet pressure gauge reading.
Verify dedicated circuit installation: correct voltage (208-240V), amperage (20A), grounding continuity, and GFCI protection. Confirm lockout/tagout capability.
Record installed firmware version from the system controller display. Verify against manufacturer's current release notes for any safety-related updates.
Verify emergency stop button location and function. Test high-pressure shutoff, leak detection sensor, and door interlock. Confirm all alarms are audible.
Verify calibration status of all integrated instruments: conductivity meter, TOC analyzer, flow meter, pressure gauges. Record calibration due dates.
7 of 12 test steps shown. Valiqa generates the full protocol in minutes.
Every protocol Valiqa generates is built on the compliance infrastructure QA directors and auditors expect.
Every change to every protocol, test step, and equipment record is logged with who changed it, when, and what the values were before and after. Insert-only. Tamper-proof. Exactly what 21 CFR Part 11 requires.
Every test step maps back to a regulatory requirement. Every requirement maps forward to a test. Coverage gaps are flagged automatically so you find them before the auditor does.
Protocols auto-link to FDA 21 CFR 820, ISO 13485, GAMP 5, EU MDR, MDSAP, and industry-specific standards. No more manual reference lookup. No more outdated citations.
If your team validates equipment, processes, or software in a regulated environment and you have been doing it in Word and Excel, Valiqa was built for you.
Whether you write the protocols, approve the budget, or answer to the auditor. Valiqa solves a different problem for each of you.
Equipment-specific test steps, acceptance criteria, and regulatory references generated in minutes. Not templates. Actual content you would write yourself, if you had the time.
Validation engineers, manufacturing engineers, process engineers
One engineer can do the work that used to take three. Protocols that took days of copy, paste, and modify now take minutes to generate and review.
QA managers, ops directors, plant managers
Built-in traceability matrix, Part 11 audit trail, and regulatory cross-references. Gaps get flagged before the auditor arrives, not during the audit.
Quality directors, VP operations, regulatory affairs
A Manufacturing Automation Engineer spent years commissioning production lines in regulated environments. Programming PLCs, configuring machine vision systems, and running full IQ/OQ/PQ validation under ISO 13485. Every protocol was a Word document copied from the last one. Every regulatory reference was pasted by hand. The validation was important. The tooling was not.
The problem was not that better software did not exist somewhere. It did. But it was built for the top 20 pharmaceutical companies in the world, priced accordingly, and sold through enterprise sales teams that would never return a call from a 50-person medical device shop.
That left the other 95% of regulated manufacturers doing validation the same way they have done it for decades: manually, in Word, one protocol at a time. Not because they chose to. Because nobody told them there was another way. Valiqa exists to change that.
Valiqa understands the regulatory landscape your products live in.
Generate audit-defensible protocols with built-in traceability, regulatory mapping, and Part 11 audit trails. 14-day free trial, no credit card.
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