FDA Validation Testing Services

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.

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

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.

Indium Software 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.

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

Indium Software 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.

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.

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

Indium Software’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

Want your App to be Flawless?

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How can we help you?

Contact us at the Indium Software office nearest to you or submit a business inquiry online.