Quality Systems
In mission-critical and regulated industries, quality is not a department — it is a discipline embedded throughout the entire organization. ADSi helps clients design, implement, and continuously improve quality management systems that ensure product integrity, regulatory compliance, and customer confidence.
Our quality systems consultants bring direct experience from pharmaceutical manufacturing, aerospace, defense, and medical device sectors where quality failures are not an option.
Quality Services
QMS Design & Implementation
Build quality management systems from the ground up or overhaul existing frameworks to meet current standards and business needs.
Regulatory Compliance
Navigate FDA, ISO, AS9100, GMP, and other regulatory requirements with expert guidance through audits, submissions, and remediation.
Process Validation
Design and execute IQ/OQ/PQ validation protocols for manufacturing and packaging processes in pharmaceutical and biotech environments.
Equipment Validation
Specification, procurement support, and validation of manufacturing and laboratory equipment to regulatory and internal standards.
Audit Preparation & Support
Prepare your team for regulatory inspections and internal audits, and provide on-site support during audit execution.
CAPA Management
Establish and optimize Corrective and Preventive Action processes to drive root cause resolution and prevent recurrence.
Standards Expertise
ADSi consultants are experienced with ISO 9001, ISO 13485, AS9100, FDA 21 CFR Parts 210/211 (pharmaceutical GMP), IATF 16949 (automotive), and other industry-specific quality frameworks. We help clients not just achieve certification, but build quality cultures that sustain compliance and drive continuous improvement long after the consultant has left.
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