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Our validation services ensure all systems, equipment, and processes consistently operate within defined parameters to produce reliable and compliant results.
Whether you're launching a new facility, expanding operations, or remediating existing systems, we meet you where you are. Our team works alongside yours to design practical, resource-conscious validation strategies that support inspection readiness and drive lasting operational results.
From initial design qualification through ongoing lifecycle management, we provide end-to-end validation services tailored to your specific operational needs and regulatory requirements.
End-to-end commissioning, qualification, and validation services for facilities, utilities, equipment, and support systems, including IQ/OQ/PQ protocol development and execution. We use a systematic, risk-based approach to confirm systems meet specifications, function properly, and are ready for GMP use.
Temperature mapping and qualification of controlled storage areas, CTUs, and critical environments, along with steam cycle qualification and sterilization validation. We ensure thermal consistency, equipment performance, and compliance with GMP and regulatory expectations.
Comprehensive validation of computerized systems and software applications used in GMP operations, ensuring data integrity, system reliability, and compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. We validate systems across their entire lifecycle from specification through retirement.
Establish documented evidence that cleaning procedures effectively remove product residues, cleaning agents, and contaminants to acceptable levels, preventing cross-contamination between batches and products. Our cleaning validation programs ensure patient safety and regulatory compliance.
Strategic planning and ongoing management of validation activities across your entire operation. We develop comprehensive Validation Master Plans (VMPs) that define validation strategies, prioritize activities, allocate resources, and establish ongoing lifecycle management programs to maintain validated status.
From planning through execution and ongoing lifecycle management, we support your validation journey at every stage.
Evaluate system requirements, define validation scope, perform risk assessment, and develop comprehensive validation strategies.
Create detailed validation protocols with clear objectives, acceptance criteria, test procedures, and documentation requirements.
Execute validation protocols systematically, perform all testing activities, document results, and investigate any deviations.
Prepare summary reports, conduct quality review of all documentation, and obtain final approvals from stakeholders.
Establish ongoing monitoring, implement change control, schedule periodic reviews, and maintain validated status over time.
Analyze validation data, identify optimization opportunities, update procedures, and refine validation strategies based on experience.
Real partnerships delivering sustainable solutions across pharmaceutical and biotech development.
Let's discuss how Amicus can support your organization's compliance, validation, and quality objectives. Whether you're launching a new facility, remediating FDA findings, or building quality systems—we're here to help.
Let's discuss how Amicus can support your compliance, validation, and quality objectives—from new facilities to FDA remediation.
Tel : (803) 839-0202
Address : 1122 Lady St 3rd floor, Columbia, SC 29201, USA
Business Hours : 8.00 AM to 5.00PM