Client Overview
The organisation is one of India's largest and most respected pharmaceutical and life sciences enterprises, with a presence spanning research, manufacturing, and distribution across multiple countries. Operating a workforce distributed across numerous business units — including Quality Control, Quality Assurance, Legal, HR, Finance, and Procurement — the organisation manages a complex, high-volume document ecosystem that is subject to stringent domestic and international regulatory requirements. Its digital transformation ambition centred on building a resilient, agile, and fully paperless signing infrastructure.
The Challenge
With more than 20,000 documents generated regularly from multiple sources and for multiple purposes, the organisation faced mounting pressure to make its operations smooth, cost-effective, automated, and globally competitive. The shift to remote working during the pandemic exposed the fragility of paper-based signing workflows, making it impossible to ensure that documents were being signed on time and by the right authority.
"In a situation where the majority of the workforce was working from home, a major challenge was to ensure that documents were being signed on time and by the right authority."
— Chief Information Security Officer and Data Protection Officer
The organisation needed a Zero Trust model for its large-scale distributed environment to maintain authenticity and non-repudiation of documents. It required verifiable and actionable compliance with FDA 21 CFR regulations, covering regulatory admissions, investigational filings, patent submissions, internal compliance, trademark registrations, and a range of operational document types including sales contracts, order processing, and field service reports. The lack of a scalable digital workflow platform meant the organisation could not effectively reduce its time-to-market or support the cultural transition to digital operations across all business units.
The Solution
eMudhra integrated emSigner with the organisation's on-premise infrastructure through open APIs in a controlled, on-premise deployment setup. This approach allowed a greater degree of customisation and internal data governance, ensuring the confidentiality required to mitigate the risk of data breach across the enterprise. Identity Validated Signature Certificates were issued to all authorised signatories, enabling them to digitally sign both individual documents and multiple documents simultaneously for regulatory submissions, lab notes, and contracts.
emSigner automated the entire document signing and processing workflow and was seamlessly integrated with the existing IT infrastructure. The eMudhra Authentication Server (emAS) was deployed to authenticate and verify digital signature certificates in real time. The solution also encompassed configuration modules for signature and encryption, electronic signature components for conducting e-KYC, and end-to-end workflow templates across all relevant business units.
On a macro level, automation enabled the organisation to comply with GxP — the collection of quality guidelines and regulations ensuring that pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. The solution also enabled bridging the gap between business, technology, and perceived digital risks, while delivering excellent Return on Security Investment (ROSI) and Total Cost of Ownership (TCO) improvement.
The on-premise deployment model provided built-in contingency, ensuring that operations could continue seamlessly even in the event that the primary platform became temporarily unavailable. The solution was designed with one-click scalability, enabling the organisation to standardise its processes globally as operations expanded.
Results
emSigner transformed the organisation's document-intensive operations, enabling it to maintain business continuity through the pandemic and beyond, while delivering measurable improvements in efficiency, compliance, and security.
Metric | Before | After |
Monthly document volume processed digitally | 0 — all paper-based | 20,000+ documents per month |
Compliance with FDA 21 CFR | Manual, inconsistent | Fully verifiable and actionable |
Signing turnaround for remote workforce | Days — dependent on physical presence | Minutes — digital workflow from anywhere |
Audit trail completeness | Fragmented, paper-based records | 100% tamper-proof digital audit trail |
Business continuity during disruption | Severely impacted | Zero downtime — built-in contingency |
Manual effort in document processing | High — printing, coordination, physical storage | Reduced by up to 80% |
