21 CFR Part 11 Compliant Control Systems | GAMP 5 Validation
Process Control System Validation is critical for ensuring consistent product quality, data integrity, and regulatory compliance in medical device, pharmaceutical, and life sciences industries. MedTech CSV provides expert validation services for 21 CFR Part 11 compliant control systems, aligned with GAMP 5 process control system validation principles.
Our risk-based approach ensures that automated and computerized process control systems are validated, secure, and inspection-ready throughout their lifecycle.
Decades of Validation Expertise. Built for Compliance. Designed for Confidence.
Our Process Control Validation Services
We support validation of process control systems used in manufacturing, testing, and quality operations by delivering:
- GAMP 5 Process Control System Validation (risk-based lifecycle approach)
- Assessment and implementation of 21 CFR Part 11 compliant control systems
- Validation planning, IQ, OQ, and PQ execution
- SOPs, validation protocols, and reports
- Change control, deviation management, and CAPA support
- Audit and inspection readiness for FDA and ISO audits
Our Validation Approach
Ensure your process control systems are validated, compliant, reliable, and fit for intended use across their lifecycle. Our validation approach supports GxP requirements, data integrity, and regulatory expectations.
1
Define validation requirements, system scope, intended use, and user requirements to establish a clear validation strategy.
2
Identify and assess critical system functions, process risks, and potential impacts on product quality and patient safety.
3
Execute Installation, Operational, and Performance Qualification to verify that systems are installed, operate, and perform as intended.
4
Evaluate electronic records, electronic signatures, access controls, audit trails, and system controls against applicable regulatory requirements.
5
Assess controls supporting ALCOA+ principles, user access, audit trails, data protection, backup, and secure system operation.
6
Maintain the validated state through controlled changes, impact assessments, deviation management, and periodic system reviews.
What is Process Control System Validation?
Process Control System Validation is the documented process of demonstrating that a control system consistently operates as intended and meets predefined quality, safety, and regulatory requirements.
Why is validation required for process control systems?
Validation helps ensure that critical systems used in regulated manufacturing operate reliably, protect product quality, maintain data integrity, and meet applicable GxP and regulatory expectations.
Which process control systems can you validate?
Validation can cover systems such as PLC, SCADA, DCS, HMI, BMS, EMS, and other computerized control systems used in pharmaceutical and regulated manufacturing environments.
What activities are included in the validation process?
Depending on the system and risk, activities may include URS, risk assessment, functional specifications, validation planning, IQ, OQ, PQ, traceability, data integrity assessment, and validation reporting.
Do you provide validation support for 21 CFR Part 11 compliance?
Yes. Validation can include assessment of relevant controls such as electronic records, electronic signatures, audit trails, user access, security, and data integrity to support applicable regulatory requirements.
Can you validate existing or legacy control systems?
Yes. Existing and legacy systems can be assessed through gap assessments, risk-based validation, retrospective review, remediation, and periodic review, depending on system history and current compliance status.
How do you maintain the validated state after implementation?
The validated state can be maintained through change control, deviation management, impact assessments, periodic reviews, configuration management, and revalidation where required.
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