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How Glenmark Simplifies Documentation
Signing with MSB Docs eSignature

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd., founded in 1977, is a global, research-driven pharmaceutical company with a strong presence in India and operations in 80+ countries. It develops branded generics, specialty, and OTC medicines, while prioritizing quality, regulatory compliance, and patient safety through continuous investment in digital quality and regulatory systems.

Business Challenge (Before Implementation)

Prior to implementation, Glenmark faced operational and compliance challenges common to large, regulated pharmaceutical enterprises:

Business Challenge Process Flow

Solution Implemented
(MSB Docs eSignature – 21CFR Part 11)

Glenmark implemented MSB Docs’ 21 CFR Part 11–compliant eSignature solution with API integrations to digitize and standardize document signing across its global operations.

Solution by MSB Docs

Glenmark Business Impact

Glenmark’s digital solutions speed up approvals, improve collaboration, and ensure stronger compliance and quality control.

Business Impact image

Key Metrics & Results

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50%

FASTER

Document approvals

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70%

Less

Time spent on audit preparation

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100%

Global

Standardization of eSign workflows

GxP Use Cases via MSB Docs
eSignature

GxP Use Case
Documents
Value / Outcome
Investigations & Deviations Management
  • Investigation Plans, RCIR, Interim & Final Investigation Reports
  • Accelerates root cause analysis and timely deviation closure
Qualification, Validation & Release Documentation
  • IQ / OQ / PQ, Release Certificates, RP Checklists
  • Enables faster batch readiness and manufacturing approvals
Reports & Summary Outcome Documents
  • Summary Reports, Hypothesis Reports, Study Protocols
  • Supports management review and regulatory submissions
Data Mapping & Traceability
  • Data Mapping Checklists, Traceability Sheets
  • Strengthens data integrity and audit confidence
Training & GxP Awareness
  • Training materials, attendance sheets, acknowledgements
  • Ensures workforce compliance and inspection readiness
Change Control & Justifications
  • Change summaries, justifications, errata
  • Enables controlled, compliant change management
Certificates & Compliance Records
  • Validation certificates, FDA forms, re-injection recommendations
  • Provides formal, and inspection-ready compliance artifacts
Risk Assessment & FMEA
  • Annexure IX, FMEA forms
  • Supports structured risk evaluation linked to quality events

Conclusion

By implementing MSB Docs’ 21 CFR Part 11 compliant eSignature solution with seamless API integrations, Glenmark successfully digitized and standardized its global documentation workflows. This transformation eliminated manual inefficiencies, strengthened compliance and governance, and enabled faster, audit-ready operations across all critical GxP processes.

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