Validation & Automation Services
Comprehensive validation and qualification services tailored for pharmaceutical manufacturing, from initial design qualification to ongoing compliance maintenance.
Computer System Validation
Ensuring Data Integrity & Regulatory Compliance
Comprehensive Computer System Validation services ensuring your GxP systems meet regulatory requirements and maintain the highest standards of data integrity.
Key Deliverables
- Validation Plan development and execution
- User Requirements Specification (URS) authoring
- Functional Requirements Specification (FRS)
- Design Qualification (DQ)
- Risk Assessment and mitigation strategies
- Traceability Matrix development
- Validation Summary Reports
Automation Engineering
PLC, SCADA & Manufacturing Systems
Expert qualification and validation of automation systems including PLCs, SCADA systems, and integrated manufacturing equipment for pharmaceutical production.
Key Deliverables
- PCS7 SCADA system qualification
- PLC/HMI validation
- Simatic Batch qualification
- OPC UA communication validation
- Manufacturing Execution Systems (MES)
- Process automation integration
- GMP file transfer validation
GxP Compliance Consulting
Navigating Regulatory Requirements
Expert guidance through complex regulatory landscapes including 21 CFR Part 11, Annex 11, and GAMP5 guidelines for pharmaceutical and healthcare industries.
Key Deliverables
- 21 CFR Part 11 compliance assessment
- EU Annex 11 requirements implementation
- GAMP5 methodology application
- Data Integrity (ALCOA+) programs
- Regulatory gap analysis
- Compliance remediation strategies
- Audit preparation and support
Qualification Services
IQ/OQ/PQ & Equipment Validation
Full lifecycle equipment and system qualification including protocol development, test execution, and comprehensive documentation for regulatory compliance.
Key Deliverables
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Test Protocol development
- Qualification Final Reports
Documentation Services
Validation Deliverables & Templates
Professional authoring of validation documentation including standard templates, procedures, and work instructions aligned with global regulatory requirements.
Key Deliverables
- Standard Operating Procedures (SOPs)
- Work Instructions authoring
- Validation template development
- System Description documents
- Configuration Specifications
- Change Control documentation
- CAPA request management
Equipment Qualification
Pharmaceutical Manufacturing Equipment
Specialized qualification services for pharmaceutical manufacturing equipment including filling lines, freeze dryers, autoclaves, and laboratory instruments.
Key Deliverables
- Optima Filling Line qualification
- Freeze Dryer validation
- Autoclave qualification
- Parts Washer validation
- QC Laboratory equipment (HPLC, DLS)
- WFI Generation/Distribution systems
- Clean/Black Steam systems
Compliance Expertise
Deep expertise in international regulatory standards ensuring your systems meet the highest compliance requirements.
21 CFR Part 11
FDA regulations on electronic records and electronic signatures for pharmaceutical and life sciences industries.
EU Annex 11
European guidelines for computerized systems in GMP environments, ensuring data integrity and system validation.
GAMP5
Risk-based approach to compliant GxP computerized systems, providing a framework for validation activities.
Need validation expertise?
Let's discuss your project requirements and how I can help ensure your systems meet regulatory compliance.