Software Testing & Validation
Techvalio delivers comprehensive Software Testing and Validation services designed for regulated industries. Our solutions ensure that applications comply with GxP guidelines and regulatory standards such as 21 CFR Part 11 and EU Annex 11 while maintaining high software quality and operational integrity.
Why Software Validation Matters
In regulated environments such as pharmaceuticals, biotechnology, and healthcare, software must be validated to ensure accuracy, reliability, and regulatory compliance. Software validation prevents data integrity issues, ensures secure system operations, and confirms that applications perform consistently according to user needs and documented requirements.
Regulatory-Driven Software Development
Techvalio ensures software development aligns with GAMP5, GMP, GLP, and GCP. We integrate compliance checkpoints into every stage of development—covering user needs, traceability, audit trails, secure access, and electronic records/e-signatures.
Key Compliance Areas:
- 21 CFR Part 11 compliance
- EU Annex 11 security and audit checks
- User requirement mapping
- Traceability matrix creation
What We Offer
GxP-Compliant Software Development Support
Ensuring software meets GMP, GLP, and GCP guidelines throughout development and deployment.
SRS & RSD Documentation
Creating detailed Software Requirements Specification (SRS) and Requirement Specification Document (RSD).
User Story to Development Conversion
Converting user stories into structured development plans under Agile methodology.
Compliance with 21 CFR Part 11 & Annex 11
Ensuring audit trails, security controls, access permissions, and data integrity are compliant.
GxP-Focused Unit Testing
Validation of individual components for accuracy, security, and functional correctness.
Validation Planning & Execution
End-to-end validation lifecycle including IQ, OQ, and PQ for full compliance.
Our Validation Process
Define Requirements (SRS & RSD)
Documenting clear functional, non-functional, and regulatory requirements.
Convert User Stories Into Plans
Developing structured execution plans using Agile methodology.
Compliance Assessment
Evaluating readiness for 21 CFR Part 11, Annex 11, and GxP compliance.
Unit Testing & Functional Testing
Testing components and workflows under GxP guidelines.
Validation Execution (IQ/OQ/PQ)
Performing complete qualification activities.
Documentation & Traceability
Creating traceability matrices, validation reports, and audit-ready documents.
Release, Support & Maintenance
Ensuring validated software remains compliant throughout its lifecycle.
FAQs
What is included in Software Validation?
It includes SRS/RSD creation, user-story mapping, unit testing, compliance checks, IQ/OQ/PQ validation, documentation, and audit readiness.
Do you ensure compliance with 21 CFR Part 11?
Yes, we validate audit trails, e-signatures, data integrity, access control, and secure configurations.
Is Agile development supported?
Absolutely. We convert user stories into actionable compliance-driven development plans.