Why choose a pre-validated QMS?

A pre-validated QMS ensures FDA and ISO compliance out-of-the-box, accelerates cloud deployment, provides audit-ready documentation with timeline traceability, supports electronic signature approvals, and offers continuous validation and updates.

How does pre-validated QMS software save money?

Pre-validated QMS software saves money by eliminating costly internal validation, reducing downtime waiting for system approval, and minimizing the risk of failed audits due to improper validation.

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Q: What compliance standards require validation?

Compliance standards that require validation include ISO 13585, ISO 9001, ISO 14001, ISO 17025, AS9100, MoCRA, FDA 21 CFR Part 11, Part 210/211, Part 820, EU GMP, EU MDR, and GxP Compliance.

Q: Is IQ, OQ, PQ included with validation?

Yes. QT9 QMS includes complete validation protocols, including Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).

Pre-validated QMS software

QT9 QMS is pre-validated for accelerated compliance.

FDA and ISO Compliance out-of-the-box
Rapid cloud deployment for faster implementation
Audit-ready with timeline traceability
Electronic signature approvals and secure access controls
Continuous validation and updates

• ISO 13585
• ISO 9001
• ISO 14001
• ISO 17025
• AS9100
• MoCRA

• FDA 21 CFR Part 11
• FDA 21 CFR Part 210/211
• FDA 21 CFR Part 820
• EU GMP
• EU MDR
• GxP Compliance

QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
Reduces downtime waiting for your QMS to be approved for use.
Minimizes the risk of any failed audits due to flawed validation protocols.

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Pre-validated QMS software

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