Staff Augmentation
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.
Risk assessment/Governance
- Perform an assessment of a specific software product
- Assess Standard Operating Procedures (SOPs) for regulatory coverage and completeness
- Assess validation documentation, identify gaps and recommend remediation steps, time frames and costs
- Develop a risk model based on GAMP 5 guidelines that reflects the industry, company and product profiles.
- Train and implement governance models.
Quality systems policies and procedures
- Write procedures for consistent deployment of software applications so as to achieve higher levels of compliance.
- Revise existing Information Technology SOPs to a more concise format to improve operational efficiency
- Incorporate recognized standards and methodologies, e.g., GAMP, ISPE, SEI, ISO, as well as industry best practices
- Implement and maintain all required policies, procedures and controls to ensure regulatory compliance.
ITIL infrastructure best practices
- Increase user and customer satisfaction
- Improve service availability, leading to increased business profitability
- Achieve financial savings from reduced rework, lost time, improved resource management and usage
- Improve time to market for new products and services
- Improve decision making and optimize risk
Software Validation
- Plan validation activities and develop Requirements Documents
- Write test cases/develop Trace Matrix
- Execute Test Cases
- Write Validation Summary Report & assemble validation documentation
- Maintain a state of regulatory compliance
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