Emcure Pharmaceuticals drives up operational excellence with streamlined SOP management and harmonized Business Processes using FineDocs ECM and FineFlow BPM ensuring compliance.Emcure Pharmaceuticals Ltd., one of India's leading Pharmaceutical Companies has world-class R&D and Manufacturing facilities across globe along with strong R&D capabilities with portfolio of differentiated products across several platforms i.e. Chirality, Bio-similars, Novel Drug Delivery Systems, etc.

The Challenge
Being part of Life Sciences Industries, Emcure is subject to the regulations mandated by the government and other professional bodies including the Food and Drug Administration (FDA). The regulations include strict requirements for managing company’s Standard Operating Procedures (SOP), compliance and regulatory frameworks for CFR 21 Part 11 for Electronic Records and Electronic Signatures, Qualification Procedures for Digital Platform, Discrepancy control using Corrective and Preventive Action (CAPA), GAMP, GXP, ISO and other Compliance Standards. Some of the Key Challenges are:
  • Manual Standard Operating Procedures (SOP) with physical storage and manual review and publishing process leads to tracking difficulties, increasing turnaround time (TAT), resulting in security breaches and compliance issues
  • Manual Format Issuance control with hard-copy registers and distribution of documents to internal and external entities becoming a real-time challenge for the authorities to control the unauthorized usage.
  • Diversified business process environment that is becoming increasingly complex with the growing volume of forms and complex approval mechanism.
  • Manual approach of using multiple siloed system interfaces leading to wearisome task with time-consuming complex navigation of records.

The Solution
Emcure Pharmaceuticals adopted FineDocs Document Management Solution in 2008 and since then Emcure shopfloors have been using the DMS capabilities to store and manage all types of documents along with SOPs. With the continuous improvement procedures, Emcure has continued to pursue digital transformation and rolled out the new capabilities of FineDocs Enterprise Content Management (ECM) and FineFlow Business Process Management (BPM) platform best met Emcure’s diverse requirements to boost user adoption automating onerous tasks, enabling instant access to information, drive decision-making and upskilling the workforce. Co-created by Emcure and Acyutah, IT Forms have been harmonized and IT processes have been streamlined using the extended digital platform of Acyutah. The platform features include:
  • SOP lifecycle management with creation, review process, publishing, version management and obsolesce, SOP and Format Issuance Control with enforced security and compliance
  • Change Control Process automation with Electronic Forms for SAP and other ERPs
  • User Management Process automation with Electronic Forms to manage Access Control to SAP and other ERPs
  • Flexible, Reusable and Decision-based IT Process Framework designed and deployed for Asset Management, Server Maintenance, Discrepancy Handling, Backup-Recovery, IT Policy, Projects Archival and more
  • Automated document distribution using shared link to integrate multiple systems maintaining single source of truth
  • FDA 21 CFR Part 11 compliance for Electronic Records for access Control, Password Aging, Audit Trails and Reporting and Electronic Signatures on E-forms approval

The Benefit
The entire industry is repositioning itself for continued success and FineDocs's flexibility and extensibility has proved beneficial to Emcure as it progresses its journey to optimize operational proficiency. Some of the Key Benefits are:
  • An Institutionalized platform for collaboration of documents with seamless document sharing among internal and external workforce with centralized single source of truth for enterprise content with enforced security
  • Improved Turnaround Time (TAT) and Real-time Visibility with automated Processes and E-forms with uncompromised Regulatory Compliance with drilled down Audit Trails and Reporting, Access Control and Electronic Signatures
  • Streamlined Standard Operating Procedures (SOP) lifecyle management, adding speed and efficiency in training and knowledge sharing process
  • Improved Information Access anytime, anywhere with greater control; Manage, Share and Reuse information from a single, authoritative information source