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Auditors with a combination of quality system and informational technology certifications bring unique insight to today’s electronic quality environments. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605148632270-BZ2GQCZ5PZ7L6LZTWT5S/11NOV2020-14001-environ.png Audit Support - 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. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605132153083-GFSLFN3G4RGC38QPTOJN/392x55-biotech-bottom-banner-black.png Audit Support - 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. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/b8e5cf80-0fdc-4e0c-a6cd-e6354be00e89/16reduced.jpg Audit Support 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 https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605132203731-IX9L34UZXWPMWLLHBQ9S/392x55-compactor-bottom-black.png Audit Support - 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. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605148580799-NHNTA03QOAMJYC8A509J/11NOV2020-1920x746-QMS-banner.png Audit Support - Quality Systems Audits for Quality Management System Standards https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605147633856-BJHA88MW8ZA8Z8MQN6C7/11NOV2020-RDC-ANVISA.png Audit Support - 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). https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605147774639-94SLX02LLM2WC5AUSUVX/11NOV2020-9001.png Audit Support - ISO 9001:2015 Immune helps manufacturers of all sizes prepare, build, and audit quality systems for compliance with ISO 9001:2015. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605216282587-IQAZ7SRS2EMT2RSHAKNQ/12NOV2020-audit-banner-3840x2160.png Audit Support https://www.beimmune.com/software-implementation daily 0.75 2023-08-16 https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605837910163-215SH8XC4XUQBBMP5CYB/19NOV2020-turn-key-implementations-1080x560.png Software Implementation - Turn Key Implementations The only thing worse than paper is reverting to paper. Plan, risk, install, customize, import, test, gather feedback, rollout, document, and train with a single vendor. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605835219867-JV5YWGSX3CN563X72LC7/19NOV2020-multivendor-single-partner-banner.png Software Implementation - A Single Resource Repeat success implementing and validating Electronic Systems from multiple vendors. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605830641750-I3LZLW1JFIZ5XUSQQVCC/19NOV2020-freeqms-eqms-banner.png Software Implementation - freeQMS The only EQMS with free-to-use modules. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605837887442-48NMQV1IYWQCE1RGNSL9/19NOV2020-eqms-certified-partner-1080x560.png Software Implementation - Certified Partner Immune is a value-added partner for FreeQMS, CAMA Software’s QCBD, Oracle’s Agile electronic quality management systems, and CloudTheApp’s fully cloud based infrastructure. A partner earns their status through repeat, successful implementations. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605837937672-GR4JWQNVCOFF8BDULZ13/19NOV2020-competition1080x560.png Software Implementation - Competitive Environment Evaluate multiple systems to find the best option. Compare and contract implementation schedules and costs. The best EQMS is the one that competes for business. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605830423295-Q8G6QW4C1C9QMTVFEQP8/19NOV2020-freeqms-paperless-conversion-1080x560.png Software Implementation - Paperless Conversion Immune helps companies considering, or already using freeQMS, to convert existing paper, or older digital quality records, to the FreeQMS system. Our powerful automated scanning software can make short work of hundreds, or even thousands, or batch records, equipment induction forms, inspection receipts, and more. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605244570010-YQN9XF4SI9NTNB4N3T7C/12NOV2020-bottom-banner-arrows-middle.png Software Implementation - Validation Validate, report, and develop a plan for re-validation. Immune validates electronic systems to a combination of industry best practices and applicable regulatory standards including 21 CFR Part 11. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605830459962-ARMLH0MI0J4UK2YO2N3E/19NOV2020-freeqms-file-upload-1080x560.png Software Implementation - Record Creation Bulk create existing quality records in freeQMS’s online quality management modules. Standardize, streamline, and upload existing data to take advantage of new automated processes. Move data from existing on-premise QMS and EQMS systems to the powerful Google Cloud that backs freeQMS for peace-of-mind. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605244558690-MZFTDOMI8P5TPPLMIJYJ/12NOV2020-bottom-banner-arrows.png Software Implementation - Implementation Implementing electronic quality management systems including quality planning, risk assessment, requirements, configuration, data inputs, and paperless conversions. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605244586439-LS1QOOMFR0G4O6GS737V/12NOV2020-bottom-banner-arrows-right.png Software Implementation - Procedures & Training Installations are complete when procedures are updated. Procedures are efficient when training is developed. Training is complete when employees prove effective. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605830503063-Y4ZAT4DMD1GJA3OYLL1S/19NOV2020-freeqms-procedure-update-1080x560.png Software Implementation - Procedure Updates freeQMS is the easiest EQMS system to use on the market. Sign up is free. The system is available immediately. Validations are included. Immune is available to help companies update existing quality system procedures and work instructions to account for the use of this powerful, quick-to-onboard platform. https://images.squarespace-cdn.com/content/v1/5fab717ca268a331f8dd468f/1605218372920-BHUU6CO9I9I2TPF3RJV1/12NOV2020-software-banner-3840x2160.png Software Implementation