PHARMACEUTICAL INDUSTRY
Pharmaceutical Automation
With Validation Built In
We deliver automation solutions designed for GMP environments—with 21 CFR Part 11 compliance, validation documentation, and change control procedures that satisfy auditors while enabling efficient production.
CHALLENGES WE SOLVE
Pharmaceutical Automation Challenges
REGULATORY COMPLIANCE
Regulatory Compliance
FDA, EMA, and other regulators require documented, validated processes.
OUR APPROACH
GAMP 5 methodology. Validation protocols, IQ/OQ/PQ documentation included.
Data Integrity
21 CFR Part 11 requires electronic records and signatures to be as trustworthy as paper.
APPROACH
Systems designed with Part 11 in mind. User authentication, electronic signatures, complete audit trails.
Serialization & Track-and-Trace
DSCSA requires unit-level serialization and complete chain-of-custody documentation.
APPROACH
Integration with serialization equipment and enterprise systems.
CLEANROOM REQUIREMENTS
Cleanroom Requirements
Automation in clean environments requires special design, materials, and procedures.
OUR APPROACH
Cleanroom-compatible equipment design. Proper gowning protocols. Low-particulate materials.
APPLICATIONS
Pharmaceutical Applications
Pharmaceutical Packaging
Primary, secondary, and tertiary packaging with serialization and verification.
Serialization & Track-and-Trace
DSCSA compliance through unit-level serialization and aggregation.
Batch & Process Automation
ISA-88 batch control with electronic batch records and recipe management.
Vision Inspection
Automated inspection of products, packaging, and labeling.
VALIDATION
Our GAMP 5 Validation Approach
Validation Deliverables
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- Design Specification (DS)
- Risk Assessment (FMEA)
- Validation Protocols (IQ/OQ/PQ)
- Traceability Matrix
- Validation Summary Report
21 CFR Part 11 Compliance
- ◆User authentication with unique IDs
- ◆Role-based access control
- ◆Electronic signatures with meaning
- ◆Complete audit trails for all changes
- ◆Data backup and recovery procedures
- ◆System security controls
All systems designed for electronic records compliance
CASE STUDY
Serialization Line Integration
Pharmaceutical Manufacturer — Midwest USAOur Solution
- Integrated serialization into 3 existing lines
- ControlLogix PLC for line coordination
- Cognex vision for print and verify
- Integration with TraceLink L4 system
- Full IQ/OQ/PQ validation package
RESULTS
- DSCSA compliance achieved on schedule
- Line efficiency impact: <3%
- Validation completed first-pass
- FDA inspection: zero 483s related to serialization
OUR SERVICES
Pharmaceutical Automation Services
PLC & Process Control
Batch automation, recipe management, and validated process control.
Learn MoreVision & Serialization
Print and verify, inspection, and track-and-trace integration.
Robotic Packaging
Automated packaging, palletizing, and material handling.
Learn MoreValidation Services
IQ/OQ/PQ protocols and documentation for regulatory compliance.
FAQ
Frequently Asked Questions
Yes. Validation is included in every pharmaceutical project. We provide complete IQ/OQ/PQ protocols per GAMP 5 methodology.
Yes. We design systems with Part 11 requirements built in: user authentication, electronic signatures, audit trails.
Absolutely. We integrate with TraceLink, SAP, Antares Vision, and other L4/L5 systems.
Yes. Our engineers follow proper gowning and cleanroom protocols.
Ready to Automate Your
Pharmaceutical Production?
Validated automation solutions for GMP environments.
