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.
Maintaining a staff to ensure compliance with regulatory requirements continues to be a challenge for many companies. Managed Services can reduce the expense of compliance when compared to the costs associated with recruiting, training and ongoing support of regulatory skill sets that may routinely fluctuate. Managed Services can also be scaled to address project or cyclical needs.
As a premier provider of regulatory validation, compliance and testing services, Arbour Group can deploy staff to any client location, or work remotely, to manage all of your compliance processes, in a full time or part time arrangement, as required.
Our managed services can be deployed in a staff augmentation model or a turnkey project support scenario. The types of projects that can be supported include:
- Software Validation Testing – we have completed projects for major enterprise software solutions, including SAP, Oracle, NetSuite, MS Dynamics, Infor, Veeva, Master Control, TrackWise, and many others.
- Change Management – we can provide a competent and efficient review, and processing of software system changes to ensure ongoing validation compliance.
- Data Integrity Assessment/Remediation – the integrity of data related to manufactured products is a US Food and Drug Administration (FDA) expectation detailed in numerous Agency
citations. FDA expects that all data be reliable and accurate. Assessment and remediation of data compliance issues will include data backup/storage, the timing of records creation,
scientifically sound controls, true copies, data completeness, etc.
- Periodic Review – review of regulatory test documentation, procedures, and practices at specified intervals is a prudent quality system practice that provides feedback on risk compliance performance and serves as a vehicle for improvement opportunities.
- Supplier Management Procedures – regulated life sciences companies are accountable for ensuring the proper selection and oversight of vendors. Written procedures must be in place
that ensures effective control of applicable vendor processes.
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.