Accelerating Pharma Manufacturing With Digital Transformation
Our solutions align with global standards including ISO 9001, ISO 15489, ISO 27001, and FDA 21 CFR Part 11, enabling organizations to confidently meet audit, retention, and compliance requirements.
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Pharmaceutical Compliance Guide
Industry Context
The pharmaceutical industry operates in a high-stakes environment where documentation is just as important as the product itself. Meeting global standards such as FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ principles requires more than just digitization—it requires intelligent, validated systems that can predict quality shifts and ensure 100% data integrity throughout the product lifecycle.
We specialize in Enterprise Content Management (ECM),Physical Record Management, Onsite & Offsite Digitizatio and Compliance-driven Information Governance—with a strong focus on regulated industries such as Pharmaceuticals, Life Sciences, Healthcare, and Manufacturing.
Key Business Challenges
Pharmaceutical manufacturers face unique challenges that require specialized solutions
Paper-based Batch Manufacturing Records
Impact: Slow batch release, manual data entry errors, and compliance delays in high-volume production.
Data Integrity & Regulatory Scrutiny
Impact: Non-compliance with ALCOA+ principles leading to FDA 483s, warning letters, and audit observations.
Manual Quality Inspection
Impact: Human fatigue and subjectivity causing inconsistent defect detection in tablets, vials, and packaging.
Siloed Data Across Systems
Impact: Lack of real-time visibility across MES, LIMS, and QMS causing delayed decision making.
Complex Change Control
Impact: Untracked changes to controlled documents and processes creating compliance gaps.
Reactive Equipment Maintenance
Impact: Unplanned downtime disrupting production schedules and causing batch losses.
Our Pharmaceutical Solutions
Comprehensive solutions designed to address every aspect of pharmaceutical manufacturing
Batch Record Automation
Transform paper-intensive batch record review into intelligent, automated processes with AI-powered eBMR and predictive maintenance.
- 45-65% reduction in manual review effort
- Batch release in hours, not days
- FDA 21 CFR Part 11 compliant
Quality Inspection & CAPA
AI-powered visual inspection, deviation analysis, CAPA management, and laboratory data management for consistent quality excellence.
- 99.5% defect detection accuracy
- 50% reduction in recurring deviations
- Faster OOS investigations
Regulatory Compliance
Complete document control, SOP management, change control, and regulatory submission support with full audit trails.
- 60% faster document preparation
- Eliminates rogue document versions
- Audit-ready at all times
Supporting Services
Digitization Services
Convert paper batch records, logbooks, and legacy documents into searchable digital formats. Our scanning and digitization services include image enhancement, OCR extraction, barcode reading, and quality verification—all integrated with your content management systems.
- Image cleansing and auto-crop
- OCR and barcode extraction
- Data validation and quality check
- On-site manpower support for bulk scanning
Records Management
Manage physical records with complete traceability. Our records management system provides secure storage, retrieval tracking, and audit trails for batch records, stability samples, and regulatory archives.
- Rack and space optimization
- Request and retrieval tracking
- Complete audit trail
Built for Regulatory Compliance
Our solutions are architected on a "Validated-Ready" framework, meticulously aligned with global regulatory mandates
Controlled electronic signatures
Secure, immutable audit trails
Time/date stamps on all actions
Role-based access controls
Ready to Transform Your Pharmaceutical Operations?
Schedule a consultation with our experts to see how we can address your specific challenges while maintaining strict regulatory compliance.
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