QSSI can assist you with each phase of the validation process for your PowerHouse implementation. QSSI and your project team will work together to define the validation plan, system requirements, roles and responsibilities, standard operating procedures and much more to ensure a meaningful validation.

The validation process encompasses several project phases that often run concurrently with the implementation of the WMS solution. The validation process contains activities that must be executed in a controlled environment to ensure the validity and repeatability of the results. A typical system validation includes the following:

• Project Management & Project Plan
• Validation Coverage
• System Requirements Specification
• System Design Specification
• System Test Strategy
• Training & Quality Planning
• Workflow Development "SOPs"
• Testing per Strategy
• Certification
• Maintaining the Validated State, Change Control

A high level of importance is placed on documenting every step of the validation process. The typical Validation Deliverables used for a PowerHouse validation include:

Project Validation Plan

The PVP is a management document describing the approach taken to ensure a software application is fully validated by identifying all of the activities and deliverables that will be required during the validation effort. The plan describes work to be done, resources required, methods to be used, the quality assurance procedures to be followed, the schedules to be met, and the project organization.

User/Functional Requirements Specification

Validation can be summarized as providing documented evidence that a system performs in accordance with predetermined specifications. The Requirements document identifies what the system must do.

Design Specifications

The System Design Specification (SDS) documents how a system is to be built. It details exactly how the hardware and software will address each functional specification. It typically includes system or component structure, algorithms, control logic, data structures, data set [file] use information, input/output formats, interface descriptions, etc.

Installation Qualification Protocol

The IQ protocol ensures that the system hardware and software were installed according to the manufacturer and [the client’s] standards. It documents that any necessary training, calibration, maintenance, and approvals have been performed, evaluates necessary utilities and environmental conditions, and records the status of the system and of the processes and procedures necessary to operate the system and maintain it in a validated state.

Operational Qualification Protocol

The OQ protocol ensures that the equipment and software functions in accordance with their documented specifications. The OQ tests the individual system functions to ensure that each functionality responds as expected and specified. The OQ will typically challenge the system by ensuring that the responses meet system specifications and expectations over the range of pre-determined allowable conditions and parameters.

Performance Qualification Protocol

The PQ ensures that the system functions in the live environment with trained end users. PQ testing consists of documenting actual system operation for a period indicative of ordinary expected use and includes stress testing indicative of conditions that the system is expected to see in use. The PQ demonstrates the ability of the system to meet user requirements and expectations.

Traceability Matrix

FDA defines Validation as objective evidence that a system meets its predetermined specifications. A Traceability Matrix is a tool used to ensure that all specifications and requirements are appropriately tested, and to avoid unnecessary testing of characteristics for which there are no specifications. [According to General Principles of Software Validation, FDA will not consider a software system to be validated without a Traceability Matrix.]

Summary and Final Reports

At the completion of each test phase, a Summary Report will be generated. This report will include a summary of all activities completed during the test execution, a listing of deviations and their resolutions. It also highlights any deviations that remain open and makes recommendations based on the results of the testing.

A Validation Final Report will be written to document the completion of testing activities and will conclude that the implementation is (or is not) considered fully validated. The VFR formally closes out the corresponding PVP.

For more information about FDA General Principles of Software Validation please visit:
http://www.fda.gov/cdrh/comp/guidance/938.html