Validation Templates

Validation projects come in all shapes and sizes. They can be as simple as ensuring a single analytical instrument is validated after a software upgrade, or as complex as a multi-site LIMS implementation. Whether you’re revalidating a single, familiar instrument—or implementing a LIMS, QMS, CDS, LMS, or MES for the first time—the assistance from templates is a no-brainer.

That’s why we’ve put together a suite of validation templates that you can download and customize to suit your unique needs. And of course, if you get into the project and find it’s more work than anticipated, we’re always right here if you need us.

Each template is $99.

Validation Plan

The blueprint for your validation, this customizable document tracks the activities, deliverables, responsibilities, and strategies to be performed during the validation. It defines the scope of the project as well as stating what is out of scope of the validation work. It also acts as a central repository for appropriate approvals, revision history, standard operating procedures, and references.

IQ Template

The installation qualification protocol verifies, with a high degree of assurance, that the instrument or system has been installed according to the manufacturer’s specifications. Included in the template are instructions for who is responsible for what pieces of the qualification, and guidance for what needs to be tested in this stage of the validation process.

OQ Template

The operational qualification protocol verifies, with a high degree of assurance, that the instrument or system meets the desired functionality of the end users. Included in the template are instructions for who is responsible for what pieces of the qualification, and guidance for what needs to be tested in this stage of the validation process.

PQ Template

The performance qualification protocol documents, with a high degree of assurance, that the instrument or system functions as intended for the user. Included in the template are instructions for who is responsible for what pieces of the qualification, and guidance for what needs to be tested in this stage of the validation process.

Validation Summary Template

The validation summary report template details the execution of the validation plan, with explanations for all deviations and test results. A change control summary and instructions for releasing the system are also included in this customizable template.

Trace Matrix

The Traceability Matrix (TM) is an important document in the Computer Systems Validation process. The TM provides a way to present a clear relationship between user requirements, functional requirements, and configuration requirements. This document will be able to link all requirements to a specific test protocol or procedure.

Functional Requirement Specification

A Functional Requirements Specification (FRS) is necessary for computer system validation as it will be used to describe what the system’s intended capabilities will be and how it will interact with other systems or instruments. A thorough FRS is needed to ensure that you have validated all functions related to the intended use. This customizable template provides space for all of the relevant requirements, with examples and suggested references.  

Configuration Specification

The Configuration Specification provides details about how the system is set up to address the user requirements of the system. It can include details about how the system is customized or configured through code. It will highlight the software and hardware requirements for both the system and everything interfaced with the system. This customizable template provides space for all of the relevant configuration details with examples and suggested references.

The User Requirements Specification (URS) is important in a computer system validation as it describes the business needs for the system. It should state clearly what the user is expecting from the system. This template provides space for all of the relevant requirements, with examples and suggested references.

A Risk Assessment is important in a computer system validation because it can help define the depth of your validation effort by identifying the critical requirements that need to be mitigated. This will help to produce an approach that is commensurate with the level of risk the system poses. A functional risk assessment is performed following the creation of the functional requirements specification to identify potential risks. Mitigation activities are then planned to manage those identify those risks, focusing on the critical areas.

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