Conduct Audits
Immune conducts scheduled audits required of regulated companies ranging from once-a-year internal audits for small manufacturers to regularly scheduled, departmental audits for institutional partners.
Immune auditors are Lead Auditor Certified, where standards allow, and are able to function as lead or support auditors.
Host Audits
For companies that lack internal audit representation, or wish to bolster existing representation, Immune hosts external auditors in the representation of a company’s quality systems.
Immune has considerable experience hosting the US FDA and in representing client quality systems to obtain certification.
Support and Assist Teams
Immune auditors are able to serve as independent assessors, or join existing, internal audit teams in institutional partners.
Auditors with a combination of quality system and informational technology certifications bring unique insight to today’s electronic quality environments.
Immune conducted a very comprehensive and value-added internal audit at Elixir Medical. They had valuable suggestions. Their approach to addressing potential gaps was objective and their explanations were very articulate, thus demonstrating their extensive (and practical) knowledge in regulations and standards. It is not very often that the audit team feels energized after an intense audit. Their conduct of audit is much appreciated by the entire audit team. Thank you! - Ira Dave, Sr. Director, Quality and Regulatory, Elixir Medical Corporation
Quality Systems
Audits for Quality Management System Standards
Single Audit Program
Immune represents companies to obtain MDSAP certification, including subsidiary standards.
21 CFR FDA Part 820
Immune performs internal audits for companies requiring compliance to, and preparing for compliance to, 21 CFR Part 820. Immune hosts the FDA for companies receiving scheduled and surprise inspections.
ISO 13485:2016
Immune helps companies prepare for certification to ISO 13485, hosts notified bodies, and performs routine internal audits.
Australia Therapeutic Goods
Immune helps companies achieve compliance and pass audits for the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3) standard, including companies based in the United States with a sales or physical presence in Australia.
Brazil Good Manufacturing
The ability to complete remote, and video audits is improving by the day. Immune retains on-staff auditors fluent in Portuegese for companies wishing to achieve compliance to Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013).
ISO 9001:2015
Immune helps manufacturers of all sizes prepare, build, and audit quality systems for compliance with ISO 9001:2015.
EH & S Systems
Environmental Health & Safety Standards Audits
EH & S
Build, audit, and maintain a safe and effective Environmental Health & Safety program with compliance to ISO 14001:2015. Immune offers combination audits to quality system and health and safety standards.
Electronic Systems
Audits for electronic controls and information tech
Electronic Records
Immune audits EQMS, ERP, CRM and other large computer systems used in manufacturing and quality record control for compliance to FDA 21 CFR part 11.
Information Security
Immune performs Information Security audits for regulated manufacturers to the ISO/IEC 27001 standard typically in combination with Part 11 compliance.
Auditor Qualifications
Credentials and Training
On-going internal training, including best practices and new standards.
Immune provides Lead Auditor training to employees through BSI, Dekra, and other accredited training bodies.
Auditors possess applicable Lead Auditor certifications in audited standards, or, when unavailable, are able to demonstrate a body of equivalent experience (lead auditor training is not offered for all auditing standards).
Demonstrable experience in conducting and hosting audits.