FDA Compliance Testing
In recent years computerized systems have become a vital part in the Medical Device and Pharmaceutical industries. At the same time, setting up and delivering optimum user/customer experience has a direct connect with your competitive edge, even survival. Some typical applications are Process Control Systems, Laboratory Information Management Systems (LIMS), 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. We also provide 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'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 & 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 generally 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