Validation

Validation engineering

How confident are you in your process consistency?

In regulated industries, validation isn't just documentation—it's your guarantee of product quality. BSI Engineering's validation process develops comprehensive programs that ensure your processes consistently produce products meeting all of your quality requirements.

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Validation strategy leadership

Quality engineered from the start

Program development

Effective validation starts with sound strategy. Our validation experts work with your team to develop comprehensive validation plans that address all aspects of your operation. We evaluate process requirements, identify critical parameters, and establish appropriate validation protocols. This systematic approach ensures thorough coverage while optimizing resource utilization.

Risk assessment innovation

Not all process parameters require equal scrutiny. Our risk-based approach helps focus validation efforts where they provide maximum value. We analyze potential failure modes, evaluate impact on product quality, and determine appropriate validation requirements. This targeted strategy helps control validation costs while ensuring product quality.

Process validation

Where certainty meets compliance

Performance Qualification (PQ)

Consistent production requires proven processes. We establish comprehensive operating parameters and rigorously verify process capability through systematic testing. Our team documents product quality metrics while confirming cleaning effectiveness across all systems. Through detailed computer system validation and establishment of monitoring requirements, we ensure reliable, compliant operations.

Continuous certification leadership

Validation extends beyond initial qualification. We develop robust ongoing monitoring programs integrated with statistical process control systems to maintain quality. Our annual product reviews and change management procedures ensure continued compliance. Through clear revalidation requirements and comprehensive documentation systems, we help maintain validated status.

Implementation

Proof in every process

Installation Qualification (IQ) leadership

Proper installation forms the foundation for process validation. Our IQ protocols verify:

Equipment installation accuracy
Utility connections
Calibration requirements
Safety systems
Control system configuration
Documentation completeness

Implementation excellence

Operational Qualification (OQ) innovation

System capability must be demonstrated. Our OQ approach confirms:

Operating parameter ranges

Control system function

Alarm responses

Safety system operation

Cleaning procedures

Standard operating procedures

Specialized expertise

Validation that adds value

Clean utility validation

Critical utilities need validation. We validate pure water systems and clean steam generation processes to ensure consistent quality. Our validation protocols cover process gases and environmental controls throughout your facility. Through systematic validation of cleaning systems and waste handling procedures, we ensure complete utility compliance.

Control system validation

Modern manufacturing depends on reliable systems. We perform thorough control system validation for both PLC and DCS platforms while ensuring data integrity requirements are met. Our audit trail implementation and electronic records compliance measures protect critical information. Through robust security protocols and validated backup systems, we help maintain operational integrity.

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Ready to enhance your validation program?

Contact BSI Engineering to discuss how our validation expertise can help ensure consistent product quality.

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