Eolus® Compliance Solutions


Eolus focuses on assisting customers in achieving regulatory compliance

 

Audits and Assessments
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.

 

Compliance Support

Eolus provides valuable guidance and assistance towards assuring compliant and secure electronic records and electronic signature systems. On the technical side, we provide extensive experience with project planning, requirements analysis, system design, product capability assessments, and vendor evaluations. We provide comprehensive regulatory compliance plans, policies, procedures, and training.

 

Software Product Capability Assessments

Eolus offers various assessment methods to determine whether or not a particular software product has the capability to meet the technical requirements. These methods may involve an audit focusing on supplier quality and software engineering practices and procedures to provide a reasonable degree of assurance in selecting software vendors.

 

Systems and Regulatory Consulting

Eolus has experienced systems consultants trained in life sciences industry best practice standards, regulations and guidelines. Our consultants have experience providing technology, systems software solutions, consulting and training to clients who strive to achieve quality and compliance with their systems.

 

Systems Compliance

Eolus solutions ensure software quality assurance and a secure system infrastructure. Our solutions are designed to meet technical and procedural requirements for compliance in regards to systems validation, system and data security, data archiving, disaster recovery and contingency planning, audit trails, and encryption.

 

Systems Development

Functional specifications, design specifications, validation plans, and test simulations are produced and controlled as a part of our validation methodology and systems development lifecycle. Software code is version controlled, documented, reviewed and tested before release. Our validation methodology and systems development lifecycle deliverables are available for review by FDA and pharmaceutical industry auditors.

 

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