FDA Validation Testing Services

Software validation based on GAMP, cGMPs & 21 CFR Part 11

In recent years computerized systems have become a vital part of the Medical Device and Pharmaceutical industries. At the same time, setting up and delivering optimum user/customer experience has a direct connect with the competitive edge, even survival. Some typical applications are Process Control Systems, Laboratory Information Management Systems (LIMS), and Clinical Data Warehousing.

FDA regulations 21 CFR Part 11, Part 820 and Part 58 mandate the need to perform Computer System Validation and these regulations have the impact of law. With extensive experience in helping top organizations implement a broad range of software validation and verification based on GAMP, cGMPs & 21 CFR Part 11, Indium’s consultants use best practices in testing IQ/OQ/PQ protocols and provide documentation on Test Scripts. Indium provides Jump Start kits (Domain Expertise, Validation & Document templates) that addresses immediate requirements.

In addition to our broad range of services, Indium offers Performance Testing (read as system availability) to ensure mission critical applications do not fail the business.

Related Links


Indium Success Stories


21 CFR part 11 Compliance testing Case Study


21 CFR Part 11 Compliance Testing


21 CFR Part 11 – Road to Successful FDA Compliance

Indium’s solution for Software Validation and Performance testing in FDA regulated industries includes the following

Developing a software validation framework

Providing the complete package of test bed and test scripts for functional testing (both UI. middleware & database), performance testing, integration testing and continuous regression testing.

Integrating quality processes & compliance tasks

Indium knows what it takes to enhance and streamline your IT-QA processes by establishing a continuous compliance process across every stage of STLC & recommending enhancements to your current processes, systems and documentation to comply with FDA’s GxP requirements and industry standards.

Solution mapping to various
compliance parameters

Indium provides one-on-one mapping solutions & comprehensive reports to various compliance parameters such as validation, software verification, independence of review and defect prevention etc.

Providing extensive documentation and process improvement reports & templates

Indium works with each organization to optimize the templates for the organization’s unique demands. This includes reviewing and enhancing existing software validation documentation including IQ/OQ/PQ. Outcome: Compliance to management expectations while driving unprecedented levels of productivity and application quality.

Jump Start Kits – Maximum value
for your Money

A typical jump-start engagement involves anywhere from one to three months of on-site/offshore services, and usually includes a blend of consulting, validation & various document templates.

Performance Testing Services
Offering include

Architecture validation from a performance engineering stand point; meeting the stated performance goals, Performance diagnostics to identify bottlenecks.

FDA Validation Testing Services

Indium’s Value proposition Capable, Scalable & Flexible service model

  • Leverage the best of the breed people, processes and tools to deliver high quality application
  • Independent Verification and Validation firm – Ensure unbiased review
  • Keep costs low with an offshore leveraged – catalog driven transaction based pricing model
  • End-to-End testing – Assist you with testing of Enterprise Apps, Data Migration Testing, Performance Testing, Functional Testing,
  • Penetration Testing, Accessibility Testing and Compatibility Testing