Anil S.
Senior CSV Analyst at ACM Medical Labs Inc
- Role
- Senior Computer System Validation Analyst at ACM Global Laboratories
- Location
- Clarksburg, MD, US
- LinkedIn followers
- 500 followers
About Anil S.
Over 5+ Years of professional experience as Validation Engineer. Expertise in computer…
Experience
Senior Computer System Validation Analyst
Jun 2023 — Present
Assessed the intended use of new applications, interfaces and embedded instrument software for GxP and 21 CFR 11 requirements.• Participated in the vendor assessments for adherence to industry standards and guidelines that includes ISO 13485, ISO 27001 and GAMP5. • Served as subject matter expert for internal customers, regarding GxP & CSV requirements. • Performed periodic compliance review for GxP systems such as LabStar, DocuWare, ClinkAxys, CT Portal, Softlab, etc. • Worked with IT and laboratory stakeholders to ensure regulatory requirements for software and instruments are met and tested. • Assisted customers with IT questionnaires and ACM site audits. • Actively participated and defended ACM validation program in multiple client audits. • Acted as CSV representative and supported effective Implementation, Validation, and maintenance of following Computerized systems and equipment with software: Analyst, BioPlex, EP Evaluator, Mesoscale, Softmax Pro, CheckPoint, ViewPoint, etc.
Education
University of California, Davis
Bachelor's degree, Biotechnology
2014 — 2017
Sacramento City College
Biology, General
2011 — 2014
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