Arbour Group understands key suppliers of materials, processes, parts, etc. must comply with the quality standards of their customer. We help life sciences companies ensure materials and process vendors establish and maintain quality standards that comply with industry standards, including FDA 21 CFR Parts 11, 211 and 820, as well as current industry best practices. Audits provide tangible feedback about a contracted manufacturer's compliance and provide objective evidence that an effective quality system is in place.
The content of the audit will vary depending on the product or service provided. However,
Arbour Group's time-proven process will include:
- Pre-audit discussion of scope, plan, objectives and regulatory expectations
- Review of system documents (such as SOPs) and previous quality assessments
- Identification of quality-critical areas in the supplier's environment
- Development a checklist that is specific to the assignment
- Execution of the audit
- Composition of audit report detailing compliance and non-compliance
- Development of a corrective action plan
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.