Industry
Pharmaceutical Automation & Electrical Engineering
Pharmaceutical manufacturing automation must be validated, documented, and audit-ready by design — we build control systems with GMP compliance and data integrity as first-class requirements, not afterthoughts.
Common challenges
- GMP validation requirements for automation systems
- Data integrity requirements (ALCOA+) for batch records
- Strict change control processes for validated systems
- Audit trail requirements across control and SCADA layers
How we solve them
- Automation design aligned to GAMP 5 validation lifecycle
- Electronic batch records with full audit trail
- Documented change control processes for validated systems
- Data integrity controls built into SCADA and historian layers
Technology
GAMP 521 CFR Part 11Electronic Batch Records
FAQ
Pharmaceutical automation frequently asked questions.
Yes, electronic records, audit trails, and access control are built in from the design stage to support your validation and compliance program.
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