Natco Pharma looks to streamline development

To help fulfil the ambitious market objectives, Natco Pharma chose to transition to digital workflows, looking for end-to-end integration of its R&D processes and data management.

"Transitioning to an electronic system would open up new possibilities for data interconnectivity and dynamic field configurations, making it unnecessary to mimic the traditional formats with repetitive data entry. When it came to selecting the right solution for Natco Pharma, we based our selection criteria on five pillars: time, cost, innovation, compliance, and data archival retrievability," says P. Rama Seshagiri Rao. The result of our review was a clear choice for Revvity Signals Notebook."

For Natco Pharma, enhanced data integrity formed a key decision factor in favor of Signals Notebook. Robust compliance with the US Food and Drug Administration’s guidelines for data – Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) – would contribute directly to the company’s ambition to accelerate regulatory processes.

“Signals Notebook helps to ensure data authenticity, accuracy, relevancy and trustworthiness. Through discussions with Revvity and with a Proof-of-Concept evaluation, we understood that Signals Notebook can facilitate compliance effectively and securely. The system generates codes and unique tracking numbers for new projects without needing to complete documentation to request these from other departments. Where documents are required – such as experimental write-up, worksheets, internal requests, tabular records with embedded calculation formulae, and test request forms – templates are provided, where the completed documents are also stored. We can configure Signals Notebook to meet the user requirement, which is particularly useful for the chemist who is working on the bench, as it allows them to go ahead to the next step quickly.”

At the broader data management and administration scale, storing documents and experimental results in a single system, alongside inventories for raw materials, instrumentation, references and working standards will save Natco Pharma valuable time.

“We can get all the information to prepare the reports very quickly. If the inventory is available in the electronic notebook, then it is very useful for the chemist to go quickly to the next step, saying that, yes, I have the raw materials to start the reaction for the feasibility study. Similarly, automatic updates of reference and working standards include a dashboard update when a standard is about to expire, prompting product retests without delay,” adds P. Rama Seshagiri Rao.

“When tasks are assigned to chemists or group leaders, using Signals Notebook we can go to the next step very quickly, include the respective tests, and assign the task to the different R&D group leaders. Traceability and easy access of experimental results reduce the time needed to prepare the technology transfer documents.”

In addition, the Signals Notebook dashboard will allow team leaders to see the status of each project, allowing them to plan for the next experiment, closure, and feedback. As the company rolls out the solution, Natco Pharma will use Signals Notebook application programming interfaces (API) to integrate data with other systems. “Cost-effective configuration, connectivity, and collaboration with other instruments is very important”, explains P. Rama Seshagiri Rao.