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.
Arbour Group understands the mission-critical importance of having a fully compliant environment. We help life sciences companies ensure their data centers are in compliance with the requirements of both domestic and international regulatory authorities, as well as reflect current industry best practices. Effective management of a company data center is a key element of a company's risk management strategy.
Data Center Compliance Offering
A data center assessment determines operational regulatory compliance through review of procedural documentation and controls along with in-depth staff interviews. The assessment process includes:
- An initial meeting to discuss/confirm scope, objectives, time frames and expectations
- Review of Data Center Assessment questionnaire with data center management to verify level of detail and coverage
- Interviews with key staff and review of processes, procedures and Standard Operating Procedures
- Review of completed data center questionnaires
- Compilation of a Report of Findings that identifies regulatory gaps vs. current regulatory expectations and best practices
- Compilation of a Compliance Plan that includes remediation steps required for full compliance
Specific assessment coverage areas include:
- Business Practices
- Organization & Resource Management
- Quality Management
- Password Control & Data Integrity
- Change Control
- Operational Controls
- Validation, Inspection & Testing
- Audit Trails
- System Support & Maintenance
- Backup, Recovery & Disaster Planning
- System and Facility Security
Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner.
The use of Arbour’s validation product greatly facilitated the process.
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers.
Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation.
Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.