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Every industry has its own unique challenges, influenced by a number of factors. These need to be addressed differently with careful understanding and focused approach. Life Sciences industry has its own set of challenges which are core to this segment, like the need of interoperable solutions, on-demand computing platforms, regulatory submissions, robust security requirements against prevalent compliance and more.
Having worked with diverse players in the Life Sciences, healthcare and payer industry, and coupled with in-house domain expertise, Silicus has been able to dissect the inherent impediments of this industry. We have a set of specialized industry offerings which have been developed while keeping into consideration the current context and futuristic goals of the pharmaceutical companies and Life Sciences ISVs.
Jose Ramon Mosteiro
Ford Oxaal
Dayon Kane
John Ferrari
Umesh Verma
Dan Boehm
Bo Keyslay
Michael Vaughn21 CFR Part 11 Solutions
The demand for IT in the Health & Life Sciences industry is on the rise to better support business needs and ensure conformance with various FDA Predicate Rules, such as, 21 CFR Part 11 and GxP for Information Systems. Computer System Validation (CSV) is a baseline to fulfill most of the FDA compliance requirements. FDA guidelines for System Validation state that every regulated system should operate in accordance to its pre-defined use and design, and the process must be supported with documented evidence.
Bearing in mind the life-critical nature of this industry and the heavy funding on stake, Silicus understands that it becomes important to have a robust quality assurance and test management plan in place. Silicus has expertise in solutions ensuring compliance through CSV in Life Sciences industry. Below are a few examples:
- Ensuring Compliance
- Gap assessment for 21 CFR Part 11 compliance
- Information and application security testing for Privacy & Security rules
- Transaction testing to ensure secure Electronic Data Interchange(EDI) across organizations
- Software Quality Assurance (SQA) check-points for process verification, code inspection, user access controls, authorizations and change controls
- Ensuring Qualification for Compliance
- Detailed IQ (Installation Qualification) & OQ (Operational Qualification) plan with test cases & test scripts
- Validation summary reports & templates
- PQ (Performance Qualification) templates and test plan for partnered UAT (User Acceptance Testing)
- Test repositories to maintain documented evidences
- Audit test plans and change/documentation control reports
- RTM (Requirement Traceability Matrix) maintenance
- Archiving and retrieval checks
- Testing for functional consistency across version upgrades
Our framework for end-to-end testing supported by SDLC-V model ensures complete coverage and fitment to purpose across Information Systems in the Life Sciences domain.