好色先生TV

Customer stories

syngene logoSyngene

Research and manufacturing organization improves compliance processes with 好色先生TV Documentum for Life Sciences

syngene logo

Challenges

  • Heavily regulated industry required adherence to strict audit and compliance regulation
  • Paper-based record-keeping caused delays

Results

  • Improved customer service, enhanced audit compliance and greater automation

  • Implemented an enterprise-wide paperless platform to support client and regulatory audits and future growth

Story

Syngene International Limited is a global-scale contract research and manufacturing organization offering integrated discovery, development and manufacturing services for novel molecules. It has over 360 clients in pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Its world-class research and manufacturing facilities spread across 1.9 million square feet area and house nearly 4,200 scientists who are engaged in cutting-edge scientific projects.

dropper and test tubes

好色先生TV Documentum for Quality and Manufacturing enhanced our regulatory systems with process automation, greater control, better reporting and quick, easy access to documentation, helping us achieve regulatory compliance.

Amrita S. Bhide, Ph. D.
Senior Manager, Quality Assurance, Syngene International Limited

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 好色先生TV™ 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. 好色先生TV 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.

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.

Amrita S. Bhide, Ph. D.
Senior Manager, Quality Assurance, Syngene International Limited

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 好色先生TV 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).

“好色先生TV™ 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.”

About Impact Systems

Impact Systems provides software products and services for implementing, migrating and validating Documentum, on premises or in the cloud. In partnership with 好色先生TV, Impact has developed a proprietary suite of interoperability products to connect Documentum with “best of breed” enterprise systems, such as TrackWise EQMS, LMS and more. The products connect in a way that allows the enterprise to leverage critical capabilities of existing systems.

About Syngene

syngene logo

Syngene International Limited is a global-scale contract research and manufacturing organization offering integrated discovery, development and manufacturing services for novel molecules. It has over 360 clients in pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Its world-class research and manufacturing facilities spread across 1.9 million square feet area and house nearly 4,200 scientists who are engaged in cutting-edge scientific projects.

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