Software Validation

Improve the Quality and Compliance of your Software Systems.

We will ensure that your software is validated to the maximum quality and regulatory standards by our team of highly qualified validation engineers.  Our validation policies and procedures adopt the key concepts of GAMP5, enabling us to deliver a comprehensive approach to software validation, delivering to FDA standards including 21 CFR Pt 11. We offer Software Validation services in the following areas:

  • Custom software validation

  • Validation of configurable off the shelf packages

  • Microsoft Spreadsheet Validation

  • Development of Validation policies and procedures

  • Software Development Life Cycle validation relating to regulatory requirements, documentation of validation policies, procedures and templates.

 

Read our latest article detailing why you should ensure you validation enginerrs are working within GAMP5 guidelines  or Contact Us for further information on our Software Validation Offering.

 

 

OUTSOURCED SOFTWARE QUALITY FUNCTION

We provide a fully outsourced Software Quality Assurance function which can map to your full life cycle, from requirements phase right through to Validation and Go Live phases. Our team of experienced Software Quality Engineers ensure that all the relevant documentation is produced as part of the system implementation and that all documents adhere to regulatory requirements. We can provide a full turnkey solution or our resources can work as part of your SQA team.

Please Contact Us if you would like further information about our Software Quality Outsource function. We also provide a fully outsourced Managed Maintenance Service to many of our clients allowing them to streamline their operations and control costs.

 

 

SOFTWARE VALIDATION TEST METHODOLOGIES

Based on your requirements we can test and Validate your software systems using the below methodologies where required:

 

  • Unit Testing

  • Integration Testing

  • Functional Testing

  • GUI Testing 

  • Usability Testing 

  • Security Testing 

  • Database Testing 

  • Configuration Testing 

  • Performance/Load Testing

  • Stress Testing

 

Contact Us today if you would like to find out more.