IT Supplier Audit

Arbour now offers IT Supplier Audit, As a global leader specializing in providing a full range of services related to regulatory software compliance, Arbour Group L.L.C. understands the mission-critical importance of having a fully compliant environment. We have helped over 200 life sciences companies ensure key suppliers establish and maintain quality systems that comply with industry standards to include FDA 21 CFR Parts 11, 211 and 820 as well as SAP Compliance and current industry best practices.

Effective management of IT Supplier Audit is a key element of a company's risk management strategy. We can determine if the proper documented evidence is in place and in use for critical suppliers to include:

Compliance Offering

Ensuring key suppliers maintain quality standards on an ongoing basis are a vital part of a Quality System that must be in place for life sciences companies. IT Supplier Audit provide tangible feedback as to a supplier's compliance and provide objective evidence that an effective Quality System is in place. During the course of an audit, the supplier's practices, policies and procedures are examined. A determination is made as to the current level of compliance through identification of gaps and development of a compliance plan to resolve deficiencies. The assessment process includes, but is not limited to the following topics, as applicable:

• General Qualifications
• Business Practices
• Quality Management
• Applications Management
• Audit Trails & Security
• Software Development Practices
• Change Control
• Defect Tracking
• Inspection & Testing
• Configuration Management
• Document Practices/Control
• Operational Controls
• Training Records
• System Backup & Support
• Service Level Agreements (SLAs)
• Product Support & Maintenance
• E-Record/E-Signature Compliance

The IT Supplier Audit Report will be developed and presented to the client in a clear and concise manner. In addition to identification of gaps, a remedial plan, scope and timeframe will be included. The findings will be presented in summary format, followed by the detailed version that included supporting documentation.

The Arbour Advantage

Arbour Group is a trusted regulatory advisor to over 200 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs