Demonstrable and repeatable quality of business processes is critical for success in several industries such as aeronautics, defense, pharmaceuticals, and other highly regulated industries. Based on our expertise in formal modeling of business process operations, establishing SLAs for stakeholders, and delivering superior process solutions by leveraging new technologies, Victrix helps clients deliver proven quality assurance solutions. Some typical validation services offered by us include manufacturing validation, product validation, and systems validation.

Manufacturing Validation

Newer equipment based on newer technologies offer richer functionality and substantial operational advantages. They might even require modifications to existing manufacturing processes to get the needed productivity. Victrix offers a full range of manufacturing validation services ranging from validating new equipment, new materials, new operations, and new statistical quality controls, all under modified environmental conditions. Our team has intimate understanding of key quality steps such as factory acceptance test, installation qualification, performance qualification, operational qualification, and in-place acceptance test of new equipment and materials for a modified manufacturing process. We use the federal guidelines, industry protocols, and best practices to ensure demonstrably high quality and standards compliance in your manufacturing process.

Product Validation

As newer products and services are introduced, it becomes critical to demonstrate product efficacy to obtain the regulatory and customer approvals needed for production introductions. Victrix offers a full range of services to help you in product validation to support new drug application. Some of our services here include product performance data capture, performance modeling, and statistical validation of product efficacy. When your marketing department considers introducing variants of existing products, we help you contain validation costs. We deliver the cost savings by using a modular approach for validation, reusing the earlier product validation data, and conducting newer validation tests primarily for modified functionality or packaging.

Systems Validation

IT systems are increasingly replacing key steps in a manufacturing process. Hence, systems need to be validated rigorously as they are becoming an integral component in the manufacturing process. Our expertise in application development, integration, and maintenance, provides us a rich perspective to proactively identify potential operational impacts and design validation procedures to test the system for those contingencies. Our application architecture know how provides an additional layer of assurance over the industry standard validation protocols such as CFR 21 part 11, GAMP4, HIPAA, and HL7 for system validation.