Eolus provides systems compliance and regulatory solutions for Life Science and Information technology industries world wide. GCP, GLP, QSR, ISO, Quality Systems, Compliance Services, Audits, Training. 21 CFR Part 11, Software Validation Methods, SDLC, Procedures, SOPs, Medical Device Software, Design Controls, Risk Management
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Eolus Inc
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Welcome to Eolus | eolusinc.com Reviews
https://eolusinc.com
Eolus provides systems compliance and regulatory solutions for Life Science and Information technology industries world wide. GCP, GLP, QSR, ISO, Quality Systems, Compliance Services, Audits, Training. 21 CFR Part 11, Software Validation Methods, SDLC, Procedures, SOPs, Medical Device Software, Design Controls, Risk Management
eolusinc.com
Eolus Library
http://www.eolusinc.com/library.html
Applicable Regulations and Guidelines. 21 CFR Part 11 Electronic Records and Signatures. General Principles of Software Validation; Final Guidance for Industry and FDA Staff. Glossary of Computerized System and Software Development Terminology. Guidance for Industry Computerized Systems Used in Clinical Trials. Quality Systems Approach to Pharmaceutical Current Good Manufacturing. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices. 21 CFR Part 11: Electr...
Compliance
http://www.eolusinc.com/compliance.html
Eolus focuses on assisting customers in achieving regulatory compliance. Eolus conducts quality system audits and provides analyses to determine appropriate technical and procedural controls for the Quality Systems, ISO 9001, ISO 12207, HIPAA, GxP predicate rules, and 21 CFR Part 11. Using proven methods and techniques; we evaluate systems, procedures, process, and technologies and provide action plans and impact analyses. Software Product Capability Assessments. Systems and Regulatory Consulting. Eolus ...
Applications
http://www.eolusinc.com/develop.html
Compliance Solutions : Systems Lifecycle Methodologies and Deliverables. Project planning and management. Scope Analysis and definition. Feasibility and Cost/Benefit Analysis. Vendor Evaluations and System Acquisition. Development and Construction or Acquisition Evaluations. Systems, Unit and Integration testing. Verification and Validation Testing. Website design by ArtsArtium.
Eolus Services
http://www.eolusinc.com/Security.html
Project Management and planning. Independent feasibility and risk analysis. System and vendor evaluations; product capability assessments. Security and infrastructure reviews. Comprehensive system portfolio assessments. Disaster recovery and security assessments. NIST 800-53, IS012207, ISO27799, 21 CFR Part 11, and HIPAA. Website design by ArtsArtium.
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http://www.eolusinc.com/requlatory.htm
Strategic planning for Design Control Lifecycles for new products or product line extensions. Response to 483s and Warning letter Action Plans. Website design by ArtsArtium.
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Welcome to Eolus
System Life Cycle Methodologies. Quality, compliance, systems, auditing and management consulting to life science and technology organizations worldwide. Eolus Solutions focus upon quality systems, information technologies, quality audits, software quality assurance, design control, training, project management, risk management, electronic records, system controls, CAPA, validation lifecycle methodologies, vendor qualifications, and systems development lifecycles. Learn more about our solutions. QSR, cGM...
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