Validation


EZSoft has significant experience delivering total solutions for Good Manufacturing Practices (GMP) applications. EZSoft services and documentation address the Computer System Validation concerns of your FDA-regulated company. Our life cycle services and associated documentation ensure that your EZSoft solution is cost effectively validated. Additionally, our S88 based development tools and object-oriented methodologies enable us to automatically generate comprehensive test protocols, providing you substantial cost savings and ensuring the accuracy, consistency and completeness of the documents for your qualified system.

EZSoft offers comprehensive professional services from initial project definition through ongoing system support. Validation services and documentation are provided by EZSoft through a system development life cycle approach to ensure ease of validation through the execution and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test protocols designed to provide documented evidence that the computerized system meets established design and functional system specification requirements.

We have extensive expertise with computer system validation efforts for pharmaceutical, biotechnology, and healthcare industry applications resulting from our successful experience on numerous projects and by monitoring the latest developments from the FDA as well as ISPE, GAMP, IEEE, and ISO. This ensures that each project will be executed effectively and completed in a timely manner with the required documentation to support your validation effort.