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The Challenge

One of the most common questions we get is whether or not validating a computer system is necessary.  The simple4st answer is:

If the computer system is used in a GXP process or used to make decisions on a GxP process or if the system stores electronic records, you need to validate the system

The challenge is how to validate a system in a timely and cost-effective manner.

The VISTX Solution

VISTX addresses the challenge in a number of ways:
  1. We utilize our Fast-Track packages to jump start the validation process
  2. We work with our clients to develop SOPs and Work Instructions that help to reduce the amount of documentation required based on risk
  3. We utilize our real-world experience to streamline the process and assist in deploying the applications in a timely manner

Let the VISTX team help you maximize the  effectiveness of your processes as well as enhance quality. VISTX works closely with you to ensure that your Validation package is complete and ready for an inspection while at the same time reducing the effort as much as possible.

Vendors

Partner with VISTX to build a Fast-Track Validation Package for your application.  What’s included?

 

VISTX Fast-Track Validation Package contents

 

Contact us to learn more

Validation Plan

The Validation Plan (VP) describes the computerized system to be validated as well as the following:

  • Scope as well as specifically out of scope
  • Validation approach
  • Roles and Responsibilities
  • Summary of Regulatory Impact
  • Risk Assessment Summary
  • Deliverables

The VP is typically the first document to be approved.

GxP and Risk Assessment

This document assesses and documents the criticality and risk level associated with this application based on the intended use.  it is intended to identify business and compliance risks and all be sed as the basis for the validation approach.

System Requirements Specification

VISTX combines the requirements (User, Functional and Configuration) into a single System Requirements Specification (SRS) to minimize approvals and ease traceability.  It is meant to define the l requirements of the system that must be met in order to successfully perform the business process.

The Design Specification might also be included in smaller systems.  All of these components may also be separated into individual documents, as needed.

Installation Qualification (Verification)

The Installation Qualifies (IQ) verifies and documents that system components (infrastructure and application) are installed in accordance with the supplier documentation, system requirements as well as design and configuration specifications.

Operational Qualification

The Operational Qualification (OQ) protocol consists of a series of tests designed to challenge the accuracy and reliability of the system’s functions and operation of the system in fully integrated loaded conditions.  The OQ tests are designed to verify the basic functionality of the system as documented within the SRS.  The OQ is created, executed and approved by VISTX and made available, as needed.

Performance Qualification

The Performance Qualification (PQ) is designed to verify the ability of the system to execute the business process as described in the System Use and Administration SOP and associated business process procedures.

Traceability Matrix

The Traceability Matrix (TM) links the user and functional requirements contained in the SRS to tests conducted in the PQ and OQ.

Summary Report

The Validation SummaryReport (VSR) summarizes the results of the validation effort.  It contains a brief description of the system, a description of the computer validation documentation, a listing of the test protocols and any failures, unusual events, or limitations encountered during testing.  Approval of the VSR indicates agreement that the computer system performs all the intended functions accurately and reliably, that related standard operating procedures are approved, and that required training is complete. Approval of the VSR finalizes the objective evidence required to accept the system as a Validated system in Production and immediately places the system under formalized Change Control.

21CFR Part 11 Assessment

This document assesses and documents the 21CFR Part 11 applicability of this application based on the intended use.

As part of this process, we also document any gaps and help to create a plan for addressing the gaps.

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