With over 20 years of experience in FDA- and ISO-regulated industries, Zilyc provides proven strategies for building and maintaining quality systems in the life sciences sector. We help companies implement robust quality management systems (QMS) that align with regulatory requirements while improving operational performance. Whether you're launching a new product, scaling manufacturing, or preparing for audits, our QA/QC solutions ensure your systems are inspection-ready and built to sustain long-term success.
We build structured QMS frameworks that ensure consistency, compliance, and traceability across your operations. Our services include:
To maintain reliable output and prevent defects, we help establish strong validation and process control systems:
Risk-based thinking is key in life sciences. Zilyc ensures your organization is prepared:
Quality isn't confined to QA departments alone. We work across R&D, manufacturing, supply chain, and QC teams to implement quality culture through training, documentation, and communication.
In the U.S., FDA 21 CFR Part 820 governs quality systems for medical devices, including diagnostics. CLIA requirements also apply to labs. Internationally, ISO 13485 and ISO 15189 define quality standards for device manufacturers and medical laboratories.
Reliable diagnostics are essential for patient safety. Errors in test results due to inconsistent processes, unvalidated equipment, or poor documentation can lead to incorrect treatments. A strong QMS ensures every step in the workflow is controlled and traceable.
We conduct mock audits, prepare documentation, and train your staff on how to respond confidently. Our team includes professionals with hands-on experience managing FDA and ISO inspections across multiple organizations.
Zilyc implements scalable document control systems with clear versioning, approval workflows, and real-time access. We train teams to follow good documentation practices (GDP) and maintain audit trails.
Ensure your operations meet the highest standards of regulatory excellence. Contact Zilyc today to strengthen your QA/QC systems and elevate product reliability in FDA- and ISO-regulated environments.
We delivers tailored solutions in biomanufacturing, quality systems, and supply chain optimization, driving efficiency and compliance in the life sciences industry.
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