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As a global leader specializing in providing a full range of services related to regulatory software compliance, Arbour Group understands the mission-critical importance of having a fully compliant environment. Life sciences companies use software solutions throughout their organization to manufacture product, control processes and generate reports related to regulated activities. These software solutions, whether on premise or in the cloud, are part of the regulatory environment. Consequently, the software developers must be managed to ensure compliance with applicable regulatory standards to include FDA 21 CFR Part 11.

Why audit your software developers and their processes?

Audits provide tangible feedback as to the software developer’s compliance profile. We help life sciences companies verify the quality standards of software developers by conducting audits as part of a vendor management process.

The audit of a software developer will include an examination of:

  • Quality Systems & Procedures
  • Software Development Life Cycle (SDLC) Processes/Practices
  • Electronic Records/Electronic Signatures
  • Security, Access Controls & Audit Trail
  • Release Management
  • Change Management
  • Operational Controls
  • Validation Deliverables
  • Training Records

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 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.

 

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