Summary of Boolean & Beyond's GMP Automation Offering
1. What Automated GMP Documentation Looks Like in Practice
Automated GMP documentation replaces manual, paper-based records with a fully digital, compliance-by-design system. In practice, this means:
- Digital SOPs, deviations, CAPA, and change control: All core GMP documents and workflows are managed in an electronic system.
- Full traceability: Every action is timestamped, every approval is captured with electronic signatures, and every document change is version-controlled.
- Enforced process steps: The system prevents users from skipping required steps or fields.
- Immutable audit trails: No record can be altered without generating an audit trail that records who did what, when, and why.
- Automated workflows: Deviations automatically trigger predefined escalation paths and CAPA workflows, ensuring consistent and timely handling.
2. Boolean & Beyond's Implementation Methodology
Boolean & Beyond deploys GMP automation in three structured phases to minimise operational disruption:
- Phase 1 (Weeks 1–4): Process Mapping
- Map existing documentation workflows across:
- SOPs
- Batch manufacturing records
- Deviation management
- CAPA processes
- Capture current approval chains, handoffs, and documentation pain points.
- Phase 2 (Weeks 5–10): System Configuration & Build
- Configure the digital platform to mirror your:
- Approval hierarchies
- Escalation rules
- Reporting and documentation formats
- Implement role-based access, electronic signatures, and audit trails aligned with your quality system.
- Phase 3 (Weeks 11–14): Parallel Run & Validation
- Run paper and digital systems in parallel to confirm:
- Completeness of records
- Alignment with existing SOPs
- User adoption and data integrity
- Refine workflows based on feedback from quality and production teams.
Throughout all phases, Boolean & Beyond’s teams in Bangalore and Coimbatore work directly with your quality assurance, quality control, and production teams to ensure the digital system reflects real shop-floor practices.
3. Regulatory Compliance and Audit Readiness
The platform implemented by Boolean & Beyond is designed to meet major regulatory expectations:
- 21 CFR Part 11 (US FDA):
- Electronic records and signatures
- Secure, computer-generated audit trails
- User authentication and access control
- EU Annex 11:
- Validation of computerized systems
- Data integrity and security
- Change and configuration management
- CDSCO (India) Guidelines:
- Alignment with Indian pharmaceutical regulatory expectations for electronic documentation and data integrity.
For audits and inspections:
- Inspectors can retrieve any record within seconds, including:
- Deviation and CAPA history
- Training and qualification records
- Equipment qualification and calibration status
- Environmental monitoring and facility data
- All information is accessible from a single dashboard, improving transparency and responsiveness.
- Pharmaceutical companies in Bengaluru using these systems report a 70–80% reduction in audit preparation time, since documents no longer need to be manually compiled from paper archives.
4. Measurable Impact on Compliance Metrics
Organizations that implement Boolean & Beyond’s digital GMP systems typically see:
- Faster deviation closure:
- Reduction from 30–45 days to under 10 days due to automated routing, reminders, and structured investigations.
- Improved CAPA effectiveness:
- Root cause analysis becomes data-driven, using historical trends and cross-record analysis instead of anecdotal inputs.
- Better tracking of CAPA implementation and effectiveness checks.
- Shorter change control cycles:
- Change control duration shrinks from weeks to days with:
- Automated impact assessments
- Parallel review and approval workflows
- Lower inspection risk:
- Digitally enforced workflows and complete traceability reduce the likelihood of:
- Data integrity observations
- Documentation gaps
- Missed signatures or incomplete records
Overall, Boolean & Beyond’s GMP automation transforms documentation from a manual, error-prone burden into a controlled, auditable, and efficient digital process that directly supports regulatory compliance and operational excellence.