InfinityQS offers two levels of validation assistance for our customers, designed to provide Advanced or Expert validation guidance for the software.
The available protocol provides essential elements for system qualification for those organizations needing to perform a formal software validation, but do not have the resources to complete the planning and required documentation to meet an implementation schedule. This "Validation Package" includes an Installation Verification / Operation Qualification (IV/OQ) protocol which contains ProFicient Functional Requirements that can be used with "User Requirements."
The Installation Verification (IV) consists of test cases to ensure that components of the ProFicient SPCEE have been properly installed according to the InfinityQS recommendation and/or documentation.
The Operational Qualification (OQ) consists of test cases to ensure that key components of the ProFicient SPCEE are properly operating 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 4.3 Sampling Requirements through the use of the Dynamic Scheduler.
Test Case Outline:
The following verification test cases are included in the IV/OQ Protocol:
- System Documentation
- Standard Operating Procedures
- ProFicient Database Manager Installation
- ProFicient SPC Enterprise Edition Installation
- Proficient Dynamic Scheduler Installation
- Operational Qualification (OQ)
The following set up and operation qualification test cases are included in the IV/OQ protocol:
- Reason for Change and Security Policy
- Organization and Roles
- Part Groups and Parts
- Process Groups and Processes
- Defect/Defective Groups and Codes
- Test/Feature Groups and Tests
- Descriptor Category and Descriptors
- Assignable Cause Groups and Corrective Action Groups
- Corrective Action Codes
- Assignable Cause Codes
- 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
InfinityQS provides the availability of additional services for those organizations requiring assistance with the execution of the IV/OQ protocol.
User Requirements Specification: Although each organization will likely have a unique User Requirements Specification (URS) based on its own operating policy, quality directives, validation needs and regulatory requirements, a generalized URS structure is self-contained in the IV/OQ protocol. This structure can assist in development of a custom URS or can be adopted where special and/or additional requirements are unnecessary.
Test Case Outline:
- Performance Qualification (PQ): The Performance Qualification (PQ) is the responsibility of each user. The PQ verifies the operation of the InfinityQS ProFicient SPCEE to ensure that the system performs as intended for use in production operations to satisfy defined and approved user requirements and user provided test case prerequisite data. InfinityQS provides the availability of additional services for those organizations requiring assistance in the development of user requirements and with the preparation & execution of customized PQ protocols.
- Validation Summary Report (VSR): The Validation Summary Report is the responsibility of the user. The VSR summarizes the results obtained from the execution of the test cases outlined the Installation Verification (IV), Operation Qualification (OQ), and the Performance Qualification (PQ), and documents the acceptance or the rejection of the system for production use.
The IV/OQ is a self contained protocol that provides:
- Review and Approval Signoff
- Revision History
- System Description
- 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 include:
- Test Requirement
- Acceptance Criteria
- Step Numbers
- Expected Results
- Pass/Fail Categorization
- Executor Signoff and Dating
- Reviewer Signoff and Dating