Syngene

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.

Syngene selected Impact Systems to implement the solution, and the project went live in just eight months from initiation.

“The flexibility of the solution has allowed us, quite straightforwardly, to easily fine-tune processes to suit our needs, enabling us to achieve the process improvements we sought,” explained Bhide.

Accessing all documentation via OpenText Documentum means users always have the latest version, and they no longer need to maintain paper copies of any document. The team ran an internal communication campaign to inform employees on the benefits of going digital, including the harmonization and alignment of processes in different departments.

With Documentum for Life Sciences, Syngene tracks the movement of every document, identifying bottlenecks or causes of delay and taking prompt corrective actions to maintain a proper audit trail. All access is controlled and recorded and can be granted programmatically to users through predefined access rules. The solution has also been integrated with the TrackWise Quality Management System, and plans are underway to integrate with Syngene’s Learning Management System (LMS).

“OpenText™ Documentum™ for Quality and Manufacturing enhanced our regulatory systems with process automation, greater control, better reporting and quick, easy access to documentation,” summarized Bhide. “We firmly believe we are on track to reduce cost, improve efficiency and above all, continue to achieve compliance.”

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