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Validation Protocol

Software Validation in the Cloud

Documentation Includes

• User Requirements

• Traceability Matrix

• Test Procedures

• Validation Report with every update

Validation Protocol Step 1 Installation Qualification (IQ)

Installation Qualification (IQ)

  • 100% automated

  • Verify the installation and configuration of the software in its selected environment

  • Modular approach with vendor and customer available qualification tests

Validation Protocol Step 2 Operational Qualification (OQ)

Operational Qualification (OQ)

  • 100% FDA compliant 21 CFR Part 11

  • Verify the software functions based on its operational specifications

  • Full documentation and signatures

Validation Protocol Step 3 Performance Qualification (PQ)

Performance Qualification (PQ)

  • 100% automated

  • Verify the software consistent performance to the specification for its day-to-day use

  • Innovative configurable test procedures to verify customer's specific use cases

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