Quality of Life for Life Sciences
Pharmaceutical
Achieve compliance, prepare for, and pass audits, and implement smarter systems. Satisfy the needs of regulators and customers.
Medical Device
Implement automation to achieve compliance with the Medical Device Single Audit Program with a single turn-key consulting team.
Biotechnology
Manage complex product material bills and product batches through electronic control of components and costs. Enterprise Resource Planning (ERP) is accessible and readily validated.
Bring Products to Market…and Keep Them There
Analyze, design, and implement programs to meet CA-FBD, US FDA 21 CFR Part 11, 58, 210, 211, 820; ISO 9001, 13485, 14971, 17025; JPAL; ANVISA; TGA; or CMDR.
Interface with regulatory agencies, satisfy reporting requirements, build device records and histories, complete submissions, obtain certificates and clearances, and develop programs that ensure lasting success.
Software System Implementation
Implement and validate software systems for regulated manufacturing, including Electronic Quality Management Systems (EQMS) in a turn-key fashion.
Immune is based in Carlsbad, CA
Global representation with in-house Spanish, Portuguese, Italian, French, and German translations available.
"The system that will transform QA."
— Laszlo Garamszegi, CTO, Aurora Spine, on Immune’s FreeQMS
FreeQMS EQMS
Immune produces FreeQMS - a revolutionary electronic quality management system with
free-to-use modules.
Expertise
Choose carefully. We specialize in consulting for life sciences. Our expertise lets us pick a great ERP or EDMS, a great operating server platform, and a future-proof infrastructure.
Growth
A system is as ROI does. Decision makers select, plan, and implement systems that grow sales and increase quality of life for company employees. Quantifiable gains rest easy with leadership.
Certified
Immune employs Exemplar Global certified auditors and consultants. Immune is a value added partner for EQMS systems.
