Pragmatrix: Experts in GMP Software Validation

Pragmatrix's validation expertise in the GMP software realm is a cornerstone of its consulting practice. With a deep understanding of the stringent regulatory requirements governing the pharmaceutical and life sciences industries, Pragmatrix provides comprehensive validation services that span the entire software development lifecycle. The company specializes in meticulous documentation and execution of User Requirements Specifications (URS), Design Specifications (DS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring that software systems meet the highest standards of quality, safety, and efficacy.

The process validation lifecycle, as expertly navigated by Pragmatrix, is a multi-faceted journey that begins with defining user needs and system requirements through URS documentation. This foundation guides the subsequent design and development process, culminating in a system that aligns with its intended purpose. Rigorous testing and documentation follow, with IQ confirming correct installation, OQ verifying system functionality per design specifications, and PQ demonstrating the system's performance under real-world conditions. Pragmatrix's validation approach not only encompasses its own software implementations but also extends to validating other software deployments, ensuring compliance and reliability across diverse systems.

Accelerate your biologics journey with PragLife

A key differentiator for Pragmatrix is its collaboration with experienced FDA validation consultants. These experts meticulously analyze the system, scrutinizing every aspect of its design, development, and operation. Their insights inform the creation of a comprehensive validation package, encompassing all essential documentation from URS to PQ. This approach ensures that validation efforts are not only thorough but also strategically aligned with regulatory expectations, providing clients with confidence in their software systems.

Pragmatrix's commitment to validation excellence extends beyond US borders. The company also provides validation services in Europe, adhering to the stringent requirements of EU ANNEX 15 of GMP.