Compliance with FDA and worldwide regulatory agencies is paramount. Abaris LifeScience has a proven methodology to ensure regulatory compliance while reducing overall costs. 1. 21 CFR Part 11 gap assessments 2. System validation services o Master validation plans (IQ,OQ,PQ) o User requirements o Traceability matrices o Test Scripts 3. Vendor and system audits 4. SOP development 5. Onsite and web based training

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