Proven Pharmaceuticals Results
Real improvements achieved by pharmaceuticals manufacturers in 90-day pilots.
9%
OEE Improvement
With full GMP compliance
12%
Batch Cycle Time
Reduction in manufacturing time
45%
Documentation Time
Automated record generation
100%
Compliance Score
Regulatory audit pass rate
Pharmaceuticals Challenges
21 CFR Part 11 electronic records compliance
Validated system requirements and documentation
Complete batch genealogy and traceability
Change control and validation procedures
Data integrity and audit trail requirements
cGMP manufacturing compliance
WiseWhy Solutions
21 CFR Part 11 compliant digital systems
Validated electronic batch record systems
Automated batch genealogy tracking
Electronic change control workflows
Comprehensive audit trail systems
Real-time process monitoring with validation
Compliance & Standards
Built-in compliance with pharmaceuticals industry standards and regulations.
21 CFR Part 11 Electronic Records
cGMP (Current Good Manufacturing Practice)
ICH Q10 Pharmaceutical Quality System
FDA Process Analytical Technology (PAT)
EU GMP Annex 11 Computerised Systems
Customer Success Story
Mid-Size Pharmaceutical Manufacturer GMP Transformation
Specialty Pharmaceutical Manufacturing Facility
Challenge
Need to improve production efficiency while maintaining strict regulatory compliance, complete batch traceability, and validated system requirements for FDA inspections.
Solution
Implemented validated 90-day pilot with 21 CFR Part 11 compliant systems, automated batch record generation, and real-time process monitoring with complete validation documentation.
Results Achieved
Overall Equipment Effectiveness
Before: 72%After: 81%
9% increase
Batch Cycle Time
Before: 18.5 hoursAfter: 16.3 hours
12% reduction
Documentation Time
Before: 4.2 hrs/batchAfter: 2.3 hrs/batch
45% reduction
Compliance Audit Results
Before: Minor findingsAfter: Zero findings
100% pass rate
Timeline: 94 days including full validation and regulatory review
90-Day Implementation Timeline
Structured approach designed specifically for pharmaceuticals manufacturing environments.
1
Validation Planning
Days 1-14- GMP compliance assessment and gap analysis
- Validation master plan development and approval
- 21 CFR Part 11 requirements specification
- User requirement specification (URS) creation
2
System Implementation
Days 15-45- Validated system installation and configuration
- Electronic batch record template development
- Audit trail and security configuration
- System integration and interface testing
3
Validation Execution
Days 46-75- Installation Qualification (IQ) execution
- Operational Qualification (OQ) testing
- Performance Qualification (PQ) validation
- Change control procedure implementation
4
Go-Live & Compliance
Days 76-90- Production system deployment and monitoring
- Operator training and competency verification
- Regulatory submission preparation
- Continuous improvement planning and ROI validation