How Cipla Automated 20,000+ Medico-Legal Documents Monthly withemSigner to Enable Data Integrity and Compliance in Remote Workflows

About the Customer

CIPLA Pharmaceutical and Life sciences redefines remote working by implementing emSigner; a workflow based digital signing solution from eMudhra in consultation with an authorized Partner: AmbiSure Technologies Pvt Ltd, to establish a resilient and agile paper-less ecosystem across business units.

Business requirement

"Automation for business units such a QC, QA, Legal, HR, Finance, Purchase, etc. is required for Operational Efficiency. This was envisioned by Mr. Kalpesh Shah for CIPLA, which led to deployment of emSigner for CIPLA.” – A C Bhayani Director & PKI Consultant, AmbiSure Technologies.

Owing to Pandemic & mandated remote operations, Business expected:

• A Zero Trust Model for a large-scale distributed environment to maintain authenticity and nonrepudiation of documents
• Verifiable and Actionable compliance with FDA – 21 CFR
• Fully automated Digital Workflow templates in overall business operations for:
  - Regulatory admissions
  - Investigational filings
  - Patent submissions, internal compliance, and trademark registrations
  - Signing sales contracts, order processing, field service reports, and more
• Reduce Time to Market by creating a digital ecosystem
• Easy cultural transition to Digital
• Digital Signatures with highest level of identity assurance and validity across the globe

Value Provided to Client

emSigner met the compliance needs, essential regulations and is now helping the client to:

• Bridge the gap between business, technology & perceived digital risks
• Achieve excellent ROSI (Return on Security Investment) & TCO
• Keep business ahead of the peers during pandemic driven shutdown and serve the business purpose without any downtime
• Digitally transform all business units and operate remotely in the new normal after the pandemic
• Deploy a Long-term “Digital Transformation” solution that works well in both the old and new normal after the pandemic
• Standardize Company’s processes globally with One click Scalability
• Leverage built-in contingency in the system if on prem platform not available

“In a situation where majority of the workforce was working from home, a major challenge was to ensure the documents were being signed on time and by the right authority” - Kalpesh Shah – CISO & DRO at CIPLA

With more than 20000+ documents generated regularly from multiple sources and for multiple purposes, operations & logistics should be smooth, cost-effective, automated and globally competitive.

Approach

emSigner platform was integrated with open APIs to perform digital signing of documents in an on prem deployment setup. This allowed a greater degree of control, customization and secure data internally to maintain the required confidentiality to mitigate the risk of data breach across the organization.

Signing Identity Validated Signature Certificates were issued to authorized signatories to facilitate digitally signing of:

• Single Document
• Multiple Documents, i.e., signing for regulatory submission, contracts, Lab Notes etc.

The Solution

CIPLA in consultation with AmbiSure Technologies Pvt Ltd, a cybersecurity solution provider and eMudhra's authorized partner for nextgen digital asset security solutions, deployed emSigner to meet the requirement for an automation solution to ensure seamless document signing, processing, data integrity, and create secure audit trail for the company.

eMudhra integrated emSigner with the on premise infrastructure at CIPLA to address the business requirements and challenges at hand. This integration enabled the client to create, modify, maintain, archive, retrieve, and transmit all the endorsed and compliant electronic records with verifiable electronic signatures. emSigner helped automate the entire document signing and processing workflow and was seamlessly integrated with the existing infrastructure in use by the client.

On the macro level, automation achieved with emSigner enabled CIPLA to comply with GxP - a collection of quality guidelines and regulations created to ensure the pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.

• On-premise digital signature workflow management to define paperless processes
• emAS - eMudhra authentication server: To authenticate and verify digital signature certificates in real-time
• Configuration module signature & encryption
• Electronic signature: To conduct e-KYC and sign documents digitally in real-time
  
  

Our Services

Build a Paperless Office From Anywhere, Anytime!
With a deep knowledge of our platform and extensive industry experience, our consultants will collaborate with you to envision a complete digital mode of managing documents and eliminating the necessity of handling physical papers and human efforts by up to 80%.

Solution for Individuals, Organizations both Large & Small
Armed with technical knowledge of our platform, our consultants can help you setup account access privileges, facilitate platform integration with existing software, and customize as per user adoption and use cases across the spectrum.

Supports Various Use Cases
Our consultants have unparalleled understanding and knowledge of helping organizations digitally transform and optimize workflows using electronic/digital signatures. This includes building document workflow templates and creating user groups to map signers to various departments like HR, Finance, Legal, etc. within a few minutes!