Solution Validation

Ensure proper installation and operations.

Verify installation and operations

InfinityQS® offers two levels of validation assistance, depending on the needs of your organization and industry.


Solution Validation

Advanced Validation

Our Advanced Validation package provides essential elements for system qualification, including installation verification (IV) and operational qualification (OQ) documentation and a validation protocol. Although your organization likely has a unique functional requirements specification (FRS) based on your specific operating policy, quality directives, validation needs, and regulatory requirements, a basic FRS document is provided with the IV/OQ protocol. The package also includes a preformatted database.
Test cases are a primary part of the Advanced Validation package. The IV documentation consists of test cases to verify that components of the InfinityQS SPC Manufacturing Intelligence (ProFicient™ SPCMI) have been installed properly according to InfinityQS recommendations and documentation. The OQ documentation consists of test cases to verify that key components of the ProFicient SPCMI are operating properly according to InfinityQS specification and are in compliance with provisions of FDA 21 CFR Part 11. The OQ can also be used to validate ProFicient sampling requirements through use of the Dynamic Scheduler. The IV and OQ protocols include the following test cases:
Verification test cases

  • System Documentation
  • Standard Operating Procedures
  • InfinityQS Database Manager Installation
  • InfinityQS SPC Manufacturing Intelligence Installation
  • InfinityQS Dynamic Scheduler Installation
  • Operational Qualification (OQ)
Setup and operational qualification test cases
  • Reason for Change and Security Policy
  • Organization and Roles
  • Employees
  • Part Groups and Parts
  • Process Groups and Processes
  • Defect/Defective Groups and Codes
  • Test/Feature Groups and Tests
  • Descriptor Category and Descriptors
  • Lots
  • Assignable Cause Group and Corrective Action Groups
  • Corrective Action Codes
  • Assignable Cause Codes
  • Alarms
  • Specification Limits
  • Sampling Requirements
  • Project and Data Configuration Setup
  • Subgroup Data Entry, Control Limits, Alarms, Warning Messages, Equation Calculation
  • 21 CFR Part 11 Regulatory Compliance (System Access, Password Aging, Electronic Records)

If you need to perform a formal software validation but lack the resources to meet an aggressive implementation schedule, InfinityQS can provide additional services to assist with the execution of the IV/OQ protocol.

Expert Validation

In our Expert Validation package, the Performance Qualification (PQ) verifies the operation of the InfinityQS ProFicient SPCMI, to confirm that the system performs as intended and satisfies defined and approved user requirements and user-provided test case prerequisite data. The PQ is the responsibility of each InfinityQS user in your organization. InfinityQS offers additional services to help develop user requirements and to prepare and execute customized PQ protocols.
The Validation Summary Report (VSR) summarizes the results of the execution of the test cases that are outlined in the package’s Installation Verification (IV), Operation Qualification (OQ), and PQ. The VSR documents the acceptance or rejection of the system for production use. Like the PQ, the VSR is the responsibility of your users.
The Expert Validation package IV/OQ is a self-contained protocol that provides the following:

  • Review and Approval Signoff
  • Revision History
  • Introduction
  • System Description
  • Scope
  • Glossary of Terms and Acronyms
  • Test Strategy (Scope, Approach, Acceptance Criteria)
  • Roles and Responsibilities
  • Test Organization
  • Deviations Handling
  • Execution Procedure and Test Review
  • Test Cases
  • Deviation Report Form
  • Deviation Report Log
  • Signature Log
  • Data Sets
  • Expected Results
All test cases in the Expert Validation package include the following:
  • Test Requirement
  • Acceptance Criteria
  • Step Numbers
  • Instructions
  • Expected Results
  • Pass/Fail Categorization
  • Executor Signoff and Dating
  • Reviewer Signoff and Dating
  • Comment

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