Question 1

What is Valiqa?

Accepted Answer

Valiqa is an AI-powered validation protocol and report generator for regulated manufacturing. You enter your equipment specs, and it generates complete IQ/OQ/PQ protocols with real test steps, acceptance criteria, and regulatory references. Not blank templates.

Question 2

What is IQ OQ PQ and how does Valiqa help?

Accepted Answer

IQ (Installation Qualification) verifies that equipment was installed correctly per manufacturer specs. OQ (Operational Qualification) verifies that equipment operates within specified ranges, including worst-case conditions. PQ (Performance Qualification) verifies that the equipment consistently produces acceptable product under real production conditions. Valiqa generates complete protocols for all three with test steps, acceptance criteria, and regulatory references specific to your equipment.

Question 3

What types of validation documents can Valiqa generate?

Accepted Answer

DQ, IQ, OQ, PQ, PPQ, CSV/CSA, PV, and TQ protocols and their corresponding reports. Valiqa also generates Validation Master Plans (VMPs) and Process Failure Mode and Effects Analyses (PFMEAs).

Question 4

Can Valiqa generate computer system validation (CSV/CSA) protocols?

Accepted Answer

Yes. Valiqa supports both traditional CSV and the newer FDA CSA risk-based approach. It generates combined IQ/OQ/PQ for software systems, including GAMP 5 categorization, risk assessment, and 21 CFR Part 11 requirements.

Question 5

How does Valiqa handle different document formats?

Accepted Answer

Upload an existing protocol and the AI learns your format. Document numbering, revision convention, header layout, test table structure, section naming. Or skip the upload and use compliant defaults that pass audits out of the box.

Question 6

Does Valiqa replace our QMS?

Accepted Answer

No. It generates content that goes into your QMS. Works alongside whatever document management system you use. MasterControl, Greenlight Guru, Veeva, SharePoint, anything else. Think of it as the authoring layer that sits upstream of your QMS.

Question 7

What regulatory standards does Valiqa support?

Accepted Answer

19 standards across 4 industries. Medical devices: FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 9001, 21 CFR Part 11, GAMP 5, EU MDR, MDSAP, UK MDR (MHRA), India CDSCO MDR, K-GMP (South Korea), and COFEPRIS (Mexico). Pharma: 21 CFR 211, ICH Q7, EU Annex 15. Food: FSMA, HACCP. Companies choose which standards apply in Settings.

Question 8

How does Valiqa help with FDA QMSR compliance?

Accepted Answer

The FDA's QMSR (effective February 2026) aligns 21 CFR Part 820 with ISO 13485, requiring companies to update their validation documentation. Valiqa generates protocols and reports that reference both frameworks, so your documentation stays current with the new requirements.

Question 9

Can I use Valiqa for process validation?

Accepted Answer

Yes. Valiqa generates process verification plans with AQL-based sampling strategies, acceptance criteria tied to product specifications, and statistical analysis frameworks.

Question 10

What is a Validation Master Plan and can Valiqa create one?

Accepted Answer

A VMP is a document that tracks every piece of equipment and software requiring validation in your facility. Valiqa generates VMP matrices with IQ/OQ/PQ requirements, validation rationale, and instrument tracking per equipment.

Question 11

Can I export to Word?

Accepted Answer

Yes. Every protocol and report exports to .docx with your company's branding, headers, footers, and formatting. PFMEAs are the one exception. Those export to .xlsx (Excel) because a 12-column risk scoring table belongs in a spreadsheet.

Question 12

Is my data secure?

Accepted Answer

Every company's data is tenant-isolated at the database level. All connections are encrypted. Every action is logged in an immutable audit trail consistent with 21 CFR Part 11 requirements.

Question 13

What industries does Valiqa serve?

Accepted Answer

Medical devices, pharmaceuticals, biotech, and food manufacturing. Each gets its own regulatory framework automatically.

Question 14

Do I need validation protocol templates?

Accepted Answer

Most companies start with templates and customize them manually for each piece of equipment. Valiqa skips the template step entirely. It generates protocols from scratch based on your specific equipment specs and the applicable regulatory framework.

Question 15

Is there an AI tool that generates IQ OQ PQ protocols automatically?

Accepted Answer

Yes. Valiqa generates complete IQ, OQ, and PQ protocols automatically from your equipment specifications. You enter the asset details - manufacturer, model, operating parameters - and Valiqa produces audit-ready protocols with test steps, acceptance criteria, and regulatory references. Not templates. Real, equipment-specific protocols.

Question 16

How is Valiqa different from MasterControl or Greenlight Guru?

Accepted Answer

MasterControl and Greenlight Guru are quality management systems (QMS) that manage documents. Valiqa generates the documents. It sits upstream of your QMS - you use Valiqa to create the protocol content, then store the finished document in whatever QMS you already use.

Question 17

How is Valiqa different from validation protocol templates?

Accepted Answer

Templates give you a blank form with placeholder text. You still spend hours filling in equipment-specific test steps, acceptance criteria, and regulatory references. Valiqa generates all of that content based on your actual equipment specs and the applicable regulatory framework.

Question 18

What is the difference between CSV and CSA for FDA compliance?

Accepted Answer

CSV (Computer System Validation) is the traditional approach requiring full IQ/OQ/PQ for every software system regardless of risk. CSA (Computer Software Assurance) is the FDA's newer risk-based approach that focuses testing effort on high-risk functionality. Valiqa supports both approaches and adjusts the protocol depth based on GAMP 5 software category.

Question 19

What is PPQ (Process Performance Qualification)?

Accepted Answer

PPQ is the final stage of process validation under FDA guidance. It demonstrates that the manufacturing process consistently produces output meeting predetermined quality criteria under commercial operating conditions. Valiqa generates PPQ protocols with statistically justified sample sizes, acceptance criteria tied to product specifications, and regulatory references to FDA Process Validation Guidance.

Question 20

What is DQ (Design Qualification) and when is it needed?

Accepted Answer

DQ verifies that the design of equipment or a system meets the intended functional and operational requirements before purchase or installation. It is typically the first step in the validation lifecycle. Valiqa generates DQ protocols that verify manufacturer specifications against user requirements.

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