Cignus Solutions has a strong IT Quality and Compliance expertise in Life Sciences and Regulated Industries. Our varied experience includes CSV, Gap Analysis, Remediation, Data Migration. Today, the delivery of top-quality validation solutions continues to be a core focus of our Professional Services consulting division, which serves the pharmaceutical, medical device, animal health, CRO, R&D, and biotech industries.
Cignus Solutions’ Validation Practice strives to provide superior service and support in a consistent and cost-effective manner. From small projects to major, long-term remediation engagements, Cignus Solutions stands behind each and every solution we deliver — and our wide range of specialties enables us to serve as an end-to-end regulatory compliance partner to our valued clients. Our team of experts has several years of experience in Computer System Validation, Infrastructure Qualification and Cloud Compliance. Our experts stay current on ISO, FDA, EMEA regulations and GAMP guidelines. We bring compliance knowledge with in-depth understanding and validation experience in several Enterprise applications, R&D systems, Manufacturing and Clinical applications.
Client: Large, Pharmaceutical Company
Project Focus: Implement the TrackWise EQMS Accelerator Solution version 8.7.13, preconfigured for the pharmaceutical industry.
Approach: Our delivery approach began with a detailed project plan and proven methodology to drive activities such as server sizing and hardware requirements, configuration, training, validation, and data migration. In as little as six months, Cignus delivered a fully implemented and validated production QMS.
Result: The project was completed on time and on budget, with the regulatory body accepting the Cignus-implemented TrackWise EQMS.
Client: Medium, CRO
Project Focus: Convert paper based QMS to EQMS process.
Approach: Our approach included the client’s needs:.
Result: Cignus successfully implemented the new EQMS in three months.