Reduced Validation Effort

Vendor-provided validation documentation reduces necessary internal validation effort while supporting regulatory compliance requirements.

Audit-Ready Documentation

Already completed validation deliverables provide documented evidence to support FDA, ISO, and regulated industry audits.

Faster, Compliant Go-Live

Validation and configuration can run in parallel, enabling faster implementation without compromising compliance readiness.

Vendor-Supported Validation Framework

QT9 provides a structured validation framework to support customer-specific validation with confidence.

Area

Without QT9

With QT9

Validation Documentation

❌ Manually creating and maintaining validation documents across multiple systems

✅ Vendor-provided validation documentation aligned to regulatory expectations

Audit Preparation

❌ Scrambling to gather evidence before audits and inspections

✅ Audit-ready documentation available when you need it

System Integration

❌ Managing disconnected QMS, ERP, and MRP tools

✅ One integrated platform for quality and operations

Process Control

❌ Spreadsheet-driven, manual processes

✅ Automated, system-controlled workflows

Implementation Effort

❌ Lengthy validation and go-live timelines

✅ Faster, compliant implementation with reduced effort

Medical Devices

Life Sciences & Pharma

Regulated Manufacturing

Quality & Compliance Teams

FDA 21 CFR Part 11

Electronic records and electronic signatures

EU cGMP / EU MDR

Manufacturing and medical device regulations

GxP (GLP, GCP, cGMP)

Good practice frameworks across regulated industries

21 CFR Part 210 / 211

Drug manufacturing controls

ISO 9001 / ISO 13485

Quality and medical device standards

AS9100

Aerospace quality management

FDA 21 CFR Part 820 (QMSR)

Medical device quality systems

ISO 17025 / ISO 14001

Laboratory and environmental systems

MoCRA

Modernization of Cosmetics Regulation Act

Why software validation matters for FDA & ISO compliance

Software validation is the documented process of ensuring a system is controlled, performs as intended and complies with applicable regulatory requirements throughout its lifecycle.

Regulatory agencies require documented evidence that software systems are controlled, verified, and fit for their intended use.

Without proper validation, organizations risk audit findings, regulatory penalties, delayed approvals, or product recalls, even when processes are otherwise well-managed.

A structured validation framework ensures systems remain compliant, traceable and inspection-ready throughout their lifecycle, not just at go-live.

IQ/OQ/PQ Documentation

Vendor-provided IQ, OQ, and PQ documentation that shortens validation timelines and supports audit readiness.

Executed Test Scripts

Pre-executed test scripts provide documented evidence of system behavior and functionality.

Regulatory Alignment

Validation materials that align with FDA, ISO and global regulatory expectations.

Core Function Evidence

Documented testing demonstrates core system functionality across key workflows.

Ongoing Validation Updates

Validation documentation is maintained alongside software updates to support continuous compliance.

Secure Cloud Deployment

Cloud-based architecture supports security, access control, and system integrity requirements.

How QT9 validates ERP & MRP software for regulated environments

QT9’s ERP and MRP functionality is validated under the same FDA- and ISO-aligned framework used for its pre-validated QMS software. Operational workflows that impact quality records, traceability and regulated manufacturing are supported by vendor-executed IQ, OQ and PQ documentation, allowing organizations to extend validated controls beyond quality processes into operations.

ERP and MRP functions that impact quality records, manufacturing traceability and regulated operations are within the scope of QT9’s validation framework. These workflows support controlled data entry, system traceability, and integration with QMS processes, helping ensure operational activities align with regulatory expectations across regulated environments.

IQ, OQ and PQ documentation for ERP and MRP workflows focuses on system installation, configuration, controlled operation, and performance across regulated operational processes.

QT9-executed testing provides documented evidence that core ERP and MRP functionality performs as intended. Customers then complete intended-use, risk-based validation within their own quality system to address site-specific workflows, configurations and regulatory requirements.

In regulated environments, ERP and MRP systems directly influence product quality, traceability and compliance records. When operational systems are not validated, organizations risk data integrity issues, audit findings, delayed approvals or product recalls — even if QMS processes are otherwise compliant.

Validating ERP and MRP workflows alongside QMS processes helps ensure end-to-end control across quality and manufacturing operations.

QMS Software

Supports validated processes for document control, CAPA, audits, training, supplier quality and change control.

ERP Software

Pre-validated ERP functionality that supports compliance without slowing operations.

MRP Software

Manufacturing and planning tools validated to support traceability, accuracy and control.

FAQ: Software Validation

Software validation is documented evidence that a system consistently performs as intended and is fit for its intended use, particularly when it impacts product quality, data integrity or patient safety.

Yes. When these systems impact regulated processes, product quality or compliance decisions, validation is typically required.

Yes. Cloud-based (SaaS) QMS, ERP and MRP software must still be validated to ensure intended performance and data integrity.

Yes. QT9 validates the software platform itself and provides vendor-level validation documentation for free.

QT9 provides executed IQ/OQ/PQ documentation and test evidence, significantly reducing internal testing, documentation and re-validation effort for its customers.

The customer is ultimately responsible for validating software for its intended use.

QT9 provides vendor-level validation documentation, including IQ/OQ/PQ artifacts and executed test evidence, to support customer validation activities. Customers use this documentation as part of their intended-use, risk-based validation in accordance with FDA, ISO, and global regulatory expectations.

This shared-responsibility model aligns with FDA guidance for commercial off-the-shelf (COTS) and SaaS software.

Pre-Validated QMS, ERP and MRP Software

What does pre-validated software mean?

The Benefits of Pre-Validated Software for Regulated Companies

Reduced Validation Effort

Audit-Ready Documentation

Faster, Compliant Go-Live

Vendor-Supported Validation Framework

What QT9 takes off your plate

Who QT9 Pre-Validated Software Is For

Regulatory standards supported by QT9 pre-validated software

Regulatory standards supported by QT9 validation

FDA Regulations

Global & ISO Standards

Industry Frameworks