Enterprise Web Applications in Basel
Validated, compliant enterprise platforms for pharmaceutical and life sciences organizations
Enterprise Web Applications in Basel
The pharmaceutical and life sciences industries demand enterprise applications with uncompromising quality, security, and regulatory compliance. AETHER Digital specializes in building validated web applications for Basel's pharmaceutical companies, biotech firms, and research institutions—platforms that must satisfy FDA, EMA, Swissmedic, and GxP requirements.
Our expertise spans clinical trial management systems, quality management systems (QMS), electronic batch records (EBR), laboratory information management systems (LIMS), document management with 21 CFR Part 11 compliance, adverse event reporting, regulatory submissions tracking, and manufacturing execution systems (MES).
Every application follows validated software development lifecycle (SDLC) principles with comprehensive documentation: user requirements specifications (URS), functional specifications (FS), design specifications (DS), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). We create traceability matrices linking requirements to testing, ensuring complete validation coverage.
Serving Basel's pharmaceutical giants and innovative biotech startups, we build platforms that accelerate drug development while maintaining rigorous compliance. Integration with SAP, Oracle, laboratory instruments, analytical equipment, and legacy systems ensures seamless data flow across your organization.
Our applications include comprehensive audit trails, electronic signatures, data integrity controls (ALCOA+), role-based access, and all features required for regulatory inspections and submissions.
Pharmaceutical giants (Roche, Novartis), life sciences, chemical industry, banking
- ✓Pharmaceutical companies in Basel
- ✓Biotech and life sciences organizations
- ✓Clinical research organizations (CROs)
- ✓Contract manufacturing organizations (CMOs)
- ✓Medical device manufacturers
- ✓Analytical testing laboratories
- ✓Regulatory affairs departments
Benefits for Basel Businesses
Full GxP validation with comprehensive documentation
21 CFR Part 11 compliance for electronic records and signatures
Integration with SAP, Oracle, and laboratory systems
ALCOA+ data integrity principles built-in
Comprehensive audit trails and change control
Support for regulatory inspections (FDA, EMA, Swissmedic)
Multi-site deployment across global pharmaceutical operations
Validated interfaces with analytical instruments and equipment
Our Process
Regulatory & Validation Planning
Define system scope, regulatory requirements (FDA, GxP), risk assessment (GAMP 5), validation strategy, and create validation master plan (VMP) with your quality assurance team.
Requirements & Design Specifications
Create user requirements specifications (URS), functional specifications (FS), and design specifications (DS). Establish requirements traceability matrix and risk mitigation strategies.
Validated Development Process
Build application following validated SDLC with code reviews, version control, and design reviews. Create test protocols (IQ, OQ, PQ) parallel to development.
Qualification & Testing
Execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Document all testing with signed protocols and summary reports.
Deployment & Regulatory Support
Deploy to validated infrastructure, provide validation documentation package, support regulatory inspections, and establish change control procedures.
What You Receive
Frequently Asked Questions
What is GxP validation and why is it required?
GxP (Good Practice) validation ensures software used in regulated industries meets quality and compliance standards. FDA and EMA require validation of computerized systems used in drug development, manufacturing, and quality control to ensure data integrity and patient safety.
How long does the validation process take?
Validation typically adds 3-6 months to the development timeline. For higher-risk systems (GAMP 5 category), validation can extend the project by 6-12 months. We plan validation activities in parallel with development to minimize delays.
Can you integrate with our existing SAP ERP system?
Yes, we have extensive experience integrating with SAP using standard interfaces (BAPIs, RFCs, IDocs, OData). Common integrations include SAP ECC, S/4HANA, SAP QM, and SAP PM modules.
What about 21 CFR Part 11 compliance for electronic signatures?
We implement complete 21 CFR Part 11 features: secure electronic signatures with unique user credentials, time-stamped audit trails, system security controls, and validation of electronic signature components.
How do you ensure data integrity (ALCOA+)?
Our applications enforce ALCOA+ principles: Attributable (user identification), Legible (readable data), Contemporaneous (real-time recording), Original (or certified copy), Accurate, plus Complete, Consistent, Enduring, and Available.
Can you support FDA or Swissmedic inspections?
Yes, we provide complete validation documentation packages, support inspection preparation, answer regulatory questions, and provide subject matter experts during inspections. Our documentation meets FDA and Swissmedic expectations.
What about change control after validation?
We establish formal change control procedures. All changes are assessed for validation impact, documented, tested appropriately, and approved before implementation. We maintain validation state throughout the system lifecycle.
Ready to Get Started? in Basel?
Let us help your Basel business dominate the digital landscape. Contact us today for a free consultation.