Benefits

Eolus® Compliance Solutions : Case Histories

CLIENT: Large International Medical Device Company

NEED: International software compliance and integration project management and oversight

SOLUTION: Eolus consultants provided international project management and served on the steering committee for the project

RESULT: Successful implementation of high quality validated systems and business solution

CLIENT: Large International Life Sciences Company

NEED: Large software implementation project management and oversight

SOLUTION: Eolus consultants provided international project management and served on the executive steering committee for the project

RESULT: Successful implementation of high quality product and business solution

CLIENT: Large International Life Science Company

NEED: ISO, Security, Data Integrity, and Compliance within full service IT department

SOLUTION: Eolus auditors performed full IT audit including infrastructure, security and application development and delivery

RESULT: Audit report identified key areas of non compliance with recommendations to achieve compliance

CLIENT: Large International Life Science Company

NEED: Process Assessment to review current and ongoing quality initiatives.

SOLUTION: Eolus auditors performed a process assessment and delivered recommendations to the organization to focus upon most critical initiatives.

RESULT: Report identified key areas of noncompliance with recommendations focused towards achieving process efficiencies.

CLIENT: Small Biotech Company in Southeast

NEED: Compliance of systems to FDA regulations was not certain. Client needed third party audit and systems guidance to redesign and implement compliant systems in an accelerated timeframe

SOLUTION: Eolus audited the vendors systems and produced recommendations for achieving and maintaining compliance to applicable regulations

RESULT: Company implemented new procedures and processes to support compliance

CLIENT: Medical Device Company

NEED: Under consent decree. Client needed third party auditors for recertification so they could be prepared for the upcoming FDA Audit

SOLUTION: Eolus auditors led software audit team and participated in the audit executive committee for recertification

RESULT: Compliant systems implemented, FDA plans to re-audit

CLIENT: Medical Device Company

NEED: The company had not yet adopted a systems lifecycle and validation methodology

SOLUTION: Eolus consultants provided full suite of processes and procedures including systems lifecycle and validation methodology based on IS012207.

RESULT: Enabled compliance to aid in product preparation for 510k submission.

CLIENT: Life Science Software Company in Northwest

NEED: Compliance of systems to FDA regulations was not certain

SOLUTION: Eolus consultants produced procedures, and provided consulting to ensure the system development processes would pass an industry vendor qualification audit

RESULT: Company implemented new procedures and policies to ensure compliance

CLIENT: Small Biotech Company in Northeast

NEED: Compliance of systems to Sarbanes Oxley and FDA regulations was uncertain. Client needed third party audit and systems guidance to redesign and implement compliant systems in an accelerated timeframe

SOLUTION: Eolus audited the companies systems and produced recommendations for achieving and maintaining compliance to applicable regulations

RESULT: Company implemented new security procedures and processes including technical controls to support compliance

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