How Zydus Lifesciences Digitized Quality & Regulatory Documentation
About Zydus Lifesciences
Zydus Lifesciences is a global pharmaceutical company operating across highly regulated markets, managing quality, engineering, and regulatory documentation under FDA 21 CFR Part 11, ICH, and global GMP standards.
Business Challenge (Before Implementation)
High-volume, compliance-critical documentation relied on manual and semi-digital approvals, leading to delays in investigations, CAPA closures, change controls, and audit readiness.
Solution Implemented (MSB Docs eSignature – 21CFR Part 11)
Zydus Lifesciences adopted MSB Docs eSignature to digitize and standardize the execution of regulated documents across departments.
Business Impact (After Implementation)
After implementing MSB Docs, Zydus Lifesciences achieved measurable improvements across compliance, speed, and governance:
Key Metrics & Results
70%
Faster Approvals
Reduced document turnaround time
100%
Traceable Records
Complete, audit-ready trails
100%
Digital
Paper-free execution
Document Management Use Cases
- Incident Summary Reports, Preliminary & Final Investigation Reports, Process Investigations, OOS & OOT Documentation
- Faster investigation closures, standardized documentation, audit-ready records
- CAPA Plans & Closure Reports, Effectiveness Check Forms, QA Review & Approvals
- Improved CAPA execution, traceable effectiveness checks, regulatory compliance
- Risk Assessment Reports, Impact Assessments, QRM Documentation
- Enhanced risk assessment, proactive mitigation, documentation for audits
- Change Control Justifications, Engineering Change (EC) Plans, EC Closure Reports
- Streamlined change approvals, reduced delays, improved compliance tracking
- Capex Approval Forms (Chillers, Autosamplers, Paste Kettles, Equipment, Software, etc.)
- Faster approval workflows, traceable capex decisions, improved transparency
- Working Standard Qualifications, Manufacturing Evaluations, Process Flow Documentation
- Efficient validation and qualification, reduced approval cycles, audit-ready records
- Executive Summary Reports, Monthly Quality & Operations Reports
- Quick decision-making, consolidated reporting, visibility across departments
- Annexures, Attachments, Data Sheets, Logs
- Centralized supporting evidence, easier audits, improved document traceability
- Conductivity Assessments, Stability Assessments, Chamber Pressure Mismatch Reports, Spike Assessments
- Accurate technical validation, standardized assessments, faster reporting
- SOPs, QA Schedules, Compliance & Governance Records
- Standardized SOPs, regulatory compliance, audit-ready documentation
Conclusion
MSB Docs eSignature helped Zydus Lifesciences accelerate and speed up approvals while strengthening compliance across regulated workflows. By adopting eSignatures as a compliance control, Zydus achieved secure, traceable, and audit-ready documentation. Life sciences organizations looking to reduce approval delays and improve inspection readiness can start their free trial of MSB Docs today and digitize with confidence.