As the scientific research partner of many leading global organizations, Syngene must comply with the regulatory requirements of India, where it is headquartered and operated, and those of the markets where its clients operate. This necessitates detailed and meticulous documentation of trial data, test results, product formulas, manufacturing processes and more in a secure and easy-to-access manner.
Amrita S. Bhide, Ph.D., senior manager of quality assurance at Syngene, expanded on the challenges the business faces saying, “On average, we have 15 audits taking place each month. Earlier, we had a paper-based system that involved maintaining a physical record of all documents, including getting physical signatures of relevant, authorized team members. This system had many limitations: difficulties in maintaining audit trails, lengthy document retrieval times and others.”
To maximize efficiency, Syngene embarked on a company-wide digital transformation initiative to transition away from a paper-based system in its quality, audit and manufacturing processes. After evaluating several solutions, Syngene selected OpenText™ Documentum™ as its enterprise document management system.“Our choice was based on the extensive capabilities of Documentum, allied to the robustness of the platform and a proven track record of successful implementation. OpenText Documentum provides us with enterprise document management designed specifically for the life sciences industry. The Quality and Manufacturing modules provide specific capabilities needed for the regulated markets we operate in,” explained Bhide.