Streamlining Pharmaceutical Documentation with Intelligent Automation

The client is an Indian multinational pharmaceutical corporation with a strong global presence. It specializes in the manufacturing and distribution of pharmaceutical formulations and active pharmaceutical ingredients. With a diversified product portfolio, the company primarily serves markets in India and the United States—two of the most highly regulated and competitive pharmaceutical landscapes.

The Challenge: Regulatory Readiness Risks

As the client continued to scale its operations across India and the United States, the absence of a centralized repository for managing confidential pharmaceutical formulations and product-related documents became a growing concern. Critical information was scattered across multiple departments and storage systems, making retrieval cumbersome and error-prone. This fragmented setup not only increased the risk of data loss but also hindered collaboration and timely access to regulatory documentation.

Compounding the issue was the lack of a standardized operating procedure for publishing and submitting product-specific documents. With over 11,000 employees spread across geographically dispersed teams, document workflows were inconsistent and largely manual. This led to inefficiencies, delays in compliance reporting, and difficulty in maintaining document integrity—particularly problematic in a highly regulated industry where accuracy and timeliness are paramount.

These challenges were most keenly felt by the Chief Operating Officer (COO), who was responsible for ensuring operational efficiency and regulatory readiness across global functions. The lack of visibility into document status and the absence of automation posed a direct risk to the organization’s ability to meet regulatory requirements and scale effectively.

The Solution: Agile Implementation Approach

To address the client’s need for a centralized, secure, and scalable document management system, Datamatics implemented a robust solution based on Documentum D2. This web-based platform served as a centralized repository, enabling seamless archiving, retrieval, and management of critical pharmaceutical documents across departments and geographies.

The solution was designed to manage a wide range of document types, including product identification forms, product specifications, chemical formulations, product development reports, clinical study documentation, and even sensitive litigation records. By consolidating these documents into a single system, the platform enhanced information traceability, access control, and regulatory compliance.

Datamatics adopted an Agile methodology to drive the implementation, ensuring iterative development with regular stakeholder feedback. This approach provided greater transparency throughout the project lifecycle, allowed for quick course corrections, and significantly improved user adoption. The flexibility and visibility of the Agile framework also empowered the client’s internal teams to stay aligned with evolving business needs, leading to faster deployment and a more responsive system tailored to their operational environment.