Pharmaceutical Process Automation for Basel
Clinical Trial Automation • Regulatory Compliance • Quality Documentation
Business Process Automation in Basel
As the global pharmaceutical capital, Basel demands automation solutions that combine speed with absolute precision and regulatory compliance. AETHER Digital delivers AI-powered process automation specifically engineered for pharmaceutical companies, biotech firms, and life sciences organizations navigating the complex landscape of drug development, clinical trials, and regulatory requirements.
Our pharmaceutical automation solutions transform time-consuming, compliance-critical processes: clinical trial data management that aggregates data from multiple sites with validation; regulatory submission preparation that compiles documentation for FDA, EMA, and Swissmedic with version control; quality documentation including batch records, deviations, and CAPA workflows; pharmacovigilance case processing from adverse event intake to regulatory reporting; and supply chain quality ensuring GMP compliance across global manufacturing.
Basel pharmaceutical companies implementing our automation achieve remarkable results: clinical data processing time reduced from weeks to days, regulatory submission preparation 60% faster with improved accuracy, quality documentation errors virtually eliminated, adverse event reporting meeting strict regulatory timelines consistently, and audit readiness dramatically improved through complete digital trails. The automation handles routine compliance tasks while alerting quality professionals to exceptions requiring expert review.
With deep expertise in 21 CFR Part 11, EU Annex 11, GxP requirements, and Swiss pharmaceutical regulations, we architect solutions that satisfy the most demanding regulatory scrutiny. Every automation maintains electronic signatures, audit trails, data integrity (ALCOA+), and validation documentation required for FDA and EMA inspections. Our Basel-based team combines pharmaceutical domain knowledge with AI development expertise, speaking both the language of drug development and cutting-edge automation technology.
Pharmaceutical giants (Roche, Novartis), life sciences, chemical industry, banking
- ✓Pharmaceutical companies accelerating clinical trial data management and analysis
- ✓Regulatory affairs teams automating submission preparation and tracking
- ✓Quality assurance departments streamlining deviation and CAPA workflows
- ✓Pharmacovigilance teams processing adverse events and regulatory reporting
- ✓Manufacturing operations automating batch records and release documentation
- ✓Supply chain quality ensuring GMP compliance across global facilities
- ✓Clinical research organizations managing multi-sponsor trial operations
Benefits for Basel Businesses
75% reduction in clinical trial data processing time across study sites
60% faster regulatory submission preparation for FDA, EMA, Swissmedic
99.9% accuracy in quality documentation and batch record generation
Automated pharmacovigilance case processing meeting regulatory timelines
21 CFR Part 11 and EU Annex 11 compliance with complete audit trails
Integration with clinical trial management systems (Medidata, Veeva)
Automated deviation tracking and CAPA workflow management
Real-time quality metrics dashboards for manufacturing operations
Electronic batch record (EBR) automation reducing release cycle time
Regulatory intelligence monitoring for guideline updates
GMP-compliant supply chain documentation automation
Validation documentation (IQ/OQ/PQ) for regulatory inspections
Our Process
GxP Process Assessment
Our pharmaceutical experts conduct comprehensive analysis of regulated workflows—clinical operations, regulatory affairs, quality assurance, pharmacovigilance, and manufacturing. We map processes against regulatory requirements (FDA, EMA, Swissmedic) to identify automation opportunities that maintain compliance.
Compliant Automation Design
We architect automation solutions with regulatory compliance at the foundation: electronic signatures, audit trails, data integrity controls, and validation requirements. Process flows incorporate quality by design (QbD) principles and risk-based validation approaches approved by regulatory authorities.
Validated Development & Integration
Development follows computer system validation (CSV) methodology with design specifications, testing protocols, and validation reports. We integrate with pharmaceutical systems (Veeva Vault, TrackWise, SAP, LIMS) using validated interfaces that maintain data integrity and traceability.
IQ/OQ/PQ Validation
Comprehensive validation following GAMP 5 guidelines: Installation Qualification verifying correct setup, Operational Qualification testing all functions against specifications, and Performance Qualification demonstrating real-world effectiveness. All validation documentation is audit-ready for regulatory inspections.
Regulatory-Ready Deployment
Controlled deployment with change control procedures, training documentation, and standard operating procedures (SOPs). Continuous monitoring ensures ongoing compliance, with periodic reviews, validation updates, and regulatory intelligence integration for guideline changes.
What You Receive
Business Process Automation in Other Areas
Frequently Asked Questions
How do you ensure 21 CFR Part 11 compliance in automated processes?
We build all pharmaceutical automation with 21 CFR Part 11 requirements from the foundation: electronic signatures with unique user authentication, comprehensive audit trails capturing all data changes, record retention and archive procedures, system validation documentation, and access controls preventing unauthorized modifications. Every automated process generates audit-ready documentation for FDA inspections.
Can automation handle clinical trial data from multiple global sites?
Yes, our automation aggregates, validates, and reconciles clinical data from EDC systems (Medidata Rave, Oracle InForm) across multiple study sites worldwide. The AI performs automated data quality checks, identifies protocol deviations, flags safety signals, and generates study reports—accelerating database lock and regulatory submission timelines while maintaining data integrity.
How does automation accelerate regulatory submissions to FDA and EMA?
We automate regulatory document compilation pulling data from clinical databases, quality systems, and manufacturing records; format documents to eCTD standards; manage version control across modules; track submission status; and generate publishing-ready dossiers. This reduces submission preparation from months to weeks while improving consistency and reducing errors that cause regulatory questions.
What validation documentation do you provide for regulatory audits?
Complete computer system validation (CSV) package following GAMP 5: User Requirements Specification, Functional Specifications, Design Specifications, Risk Assessment, Test Protocols and Results, Traceability Matrix, Validation Summary Report, and ongoing change control documentation. All materials are audit-ready and support regulatory inspections by FDA, EMA, and Swissmedic.
Can it automate pharmacovigilance and adverse event reporting?
Absolutely. Our automation processes adverse event reports from multiple sources (clinical trials, post-market surveillance, literature), performs medical coding (MedDRA), determines regulatory reporting requirements, generates expedited reports meeting timelines (15-day, 7-day), and submits to regulatory authorities. This ensures compliance with pharmacovigilance regulations while reducing manual workload.
How does it integrate with our Veeva Vault and quality systems?
We have extensive experience integrating with Veeva Vault (RIM, QualityDocs, QMS), TrackWise, MasterControl, and SAP QM using validated APIs. Automation can retrieve documents, update records, trigger workflows, and generate reports while maintaining audit trails and data integrity required for GxP compliance. All integrations are validated following CSV methodology.
What ROI do pharmaceutical companies see from process automation?
Basel pharma clients typically achieve 50-75% reduction in clinical data processing time (accelerating time to market), 60% faster regulatory submission preparation, 40% reduction in quality documentation workload, and 99%+ improvement in compliance metrics. For a single drug development program, automation can save months in development timelines—representing hundreds of millions in revenue opportunity.
How do you handle validation when processes or systems change?
We implement robust change control procedures following ICH Q9 risk-based approaches. Minor changes undergo impact assessment and targeted regression testing. Major changes trigger formal revalidation with updated documentation. We provide ongoing validation support, ensuring your automation remains compliant as systems evolve, regulations change, and new capabilities are added.
Ready to Get Started? in Basel?
Let us help your Basel business dominate the digital landscape. Contact us today for a free consultation.