Validation is an integral part of the pharma industry and must be done for every software that an organization uses. It is required to assess if the software complies with cGMP requirements. With technological advancement in the industry and more online and virtual processes in play.
Our regulatory services for Computer System Validation (CSV) are designed to help life sciences and pharmaceutical companies achieve compliance with global regulatory requirements. With a focus on risk management, system integrity, and operational efficiency, our services provide a streamlined approach to validating and maintaining computerized systems critical to your business operations.
Assessment is the process of evaluating or estimating the nature, ability, or quality of something. It's a broad term that can apply to a variety of contexts, including education, business, healthcare, and more Accurate, reliable, and fair assessments contribute to improved learning, development.
Adhering to GDPR and HIPAA ensures the protection of sensitive data through strict guidelines on collection, storage, and processing. Encrypted documentation and storage solutions secure data by making it unreadable to unauthorized users, safeguarding privacy and ensuring compliance.
We use top-tier tools like ValGenesis and Kneat for validation, alongside testing frameworks such as HP ALM, Jira, and Selenium to ensure efficient and accurate system performance.
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Deployed a Professional team and Accomplished The Successfull completion of the CSV Project with in our Organization.They Delivered a High Quality out for Chromotography and purified Water System Integrated with PLC-HMI Systems All while ensuring strict adherence to Regulatory standards.
Mangalam Organics Limited
VINS BIOPRODUCTS LIMITED
ORCH Laboratories India Pvt.Ltd
Extrovis Private Limited
ISO Quality Management System