Software Validation

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1. What is the purpose of the Validation Pack ?

If your company is involved, in among others, the healthcare, pharmaceutical and biotechnology industries, its entire quality control system has to be validated. This encompasses, not only the system as a whole, but also the individual elements and components that make up the system.

The ultimate responsibility for the validation of your system lies with your company. However, vendors of proprietary software, such as Calibration Toolbox ADO, can play their part by providing you with validation documentation for their software, and tools for testing the software in its intended location, i.e. in your company.

Calibration Toolbox ADO, which is widely used throughout the above industries, is designed to automate parts of your company's quality control system and, because of this, has been subjected to strict validation/verification procedures. It is classed as "off the shelf" software in which by definition you, the end-user, played no direct part in the specification, development and testing. One of the key purposes of this document to demonstrate to you and any inspectorate, that the software has been designed, developed and tested in accordance with the internationally accepted guidelines for software validation.

2. What are Validation and Verification ?

The U.S. Food and Drug Administration (FDA) defines software validation as "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through the software can be consistently fulfilled".

Quite simply stated, validation proves that the software does exactly what you need.

Software verification, on the other hand, "looks for consistency, completeness and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated". In other words verification, which includes software testing, forms part of the validation process.

Again, simply stated, verification proves that the software accurately and consistently carries out the tasks for which it was designed.

3. What Does this Validation Pack Contain ?

The validation pack is in two volumes which contain:

VOLUME 1 - Validation and Verification Carried out on Calibration Toolbox ADO as part of the Software Development Process

1. A description of the System Requirements Specification.

2. A description of the Validation Plan including test procedures and specifications used for the in-house validation of the software

3. A report on the final tests carried out on Calibration Toolbox ADO

Volume 1 demonstrates that Calibration Toolbox ADO was designed and tested in accordance with internationally accepted software validation principles. A comprehensive system requirements specification is given and results of key software tests provided.

Also in the documentation a detailed description is provided on how the project of developing Calibration Toolbox ADO was carried out in terms of change management and verification and integration testing.

VOLUME 2 - End-User Software Validation

1. Guidelines for validation of Calibration Toolbox ADO by the user in its intended location.

This second volume is intended to help you, the Calibration Toolbox ADO user, validate the software in the location in which you intend to use it. Consider it as a follow on to the documentation in the first volume (in other words we have done our part we are now going to help you to carry out yours).

This documentation is structured so that you can complete all of the necessary validation tasks as quickly and efficiently as possible.


Should you require external sources of reference for your software validation, there are several excellent sources of reference, in particular, the US Food & Drug Administration FDA web site and the web site of the US National Institute of Standards & Technology. NIST.