Welcome to Immune

Immune INC is San Diego’s premier Quality Assurance and Regulatory Affairs consulting firm. Immune specializes in effective quality management system implementation and optimization for pharmaceutical, medical device, and biotechnology companies.

We help customers 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 utilizing Electronic Quality Management Systems (EQMS) in a turn-key fashion complete with validations and IOQs.

Immune employs Exemplar Global certified auditors and consultants, and Microsoft certified technology consultants. Immune is a Microsoft Partner and value added re-seller for EQMS systems.

Capabilities

QA/RA Consulting

We’re here to solve complex issues. Click to learn more about Quality and Regulatory Assurance. We never hesitate to demonstrate past success. Contact us to see how we’ve cleared past hurdles.

Audit Support

Outside opinions improve quality. Unexpected visits raise nerves. We help with both. Click to learn more about Audit Support for most Quality Management and Environmental Health and Safety standards.

Software Implementation

Quality is better when electronic. Learn more about implementing modern computer systems that reduce workload, increase productivity, and expand output.

FreeQMS

Our very own EQMS. Built with modern technologies. Cloud native. Validations included. Customization not required. Did we mention it has Free Modules?

CAMA Software Preferred Vendor

Immune is CAMA Software’s only Preferred Vendor/Partner Program Member in San Diego County. Extensive information on the software is available on CAMA’s website.

We are able to install, customize, implement, and validate the QCBD system. Q.C.B.D or “Quality Collaboration By Design” is a software system produced in California by CAMA Software. QCBD is a simple, yet effective, and cost-conscious electronic document management system (EDMS). This software can be implemented to manage Electronic Records in a Medical Device, Biologics, or Pharmaceutical manufacturing environment. This system is fully 21 CFR part 11 compliant and also contains module which satisfy all 21 CFR part 58, 210, 211, and 820 regulations. The QCBD system is also ideal for any manufacturing organizations following ISO 9001 or 13485 standards.

We are able to assist with customizing each module to fit individual business processes and needs. Immune can also assist with customizing the out of box CAMA provided Validation Protocols to fit the needs of any organization.

*Immune can provide history and proof of previous Part 21 CFR-compliant implementations of QCBD including two-step authentication and examples of previously customized validation protocols. The QCBD includes validation protocols for each individual module within the software. Parts, or all of the modules with associated validations can be customized to fit your business needs while retaining functionality to comply with 21 CFR part 11. The areas of functionality and customization for each module are clearly explained within the out of box QCBD software configuration. This is one of the best features of the QCBD software.