Watch the ERP systems compliance and validation webinar!
Go to WebinarAs a global leader in regulatory compliance and software testing services to Life Science companies, Arbour Group understands the mission-critical importance of achieving and maintaining a compliant environment. We utilize our proven risk-based methodologies along with regulatory guidance to ensure compliance with industry standards to include 21 CFR Parts 11, 211 and 820, as well as with industry best practices. Our quality assurance services ensure ongoing compliance in a supply chain arena that is becoming more intricate, dispersed and integrated.
Arbour Group utilizes our life science experience with the recommendations afforded in guidelines such as ICH Q9, Quality Risk Management, ISO 14971, Application of Risk to Medical Devices and GAMP 5, Good Automated Manufacturing Practices Guide to tailor a definitive risk approach to reflect risk exposure.
Arbour Group understands that effective policies and procedures are critical to achieving higher levels of compliance and reducing the total cost of software ownership. A company's Quality Policies and Information Technology Standard Operating Procedures (IT SOPs) allow for consistent deployment of software applications and serve as the foundation of organizational training. Our professionals have the technical expertise and regulatory experience to create policies, IT SOPs and work instructions that will effectively guide your organization. We prove assistance in all phases of quality policy and IT SOP development to ensure increased operational efficiency.
An effective relationship with key suppliers is critical to ensure that the entire regulatory environment is compliant. Essential to that relationship is putting a quality agreement in place so that the quality standards of the manufacturer are known by key suppliers, which can then ensure compliance. A quality agreement clarifies exactly what is expected of both parties and defines the duties, responsibilities and metrics that will reduce regulatory risk and ensure compliance throughout the supply chain.
Periodic document review is a proactive quality practice that effectively decreases risk. Arbour Group's in-depth experience with compliance provides a client-focused approach with an agency weathered methodology. Intermittent document review ensures critical systems are in an effective state of compliance and up to date with current FDA regulations and guidelines. Periodic Reviews can be an effective double check of a company's risk and compliance performance. Additionally, these intermittent reviews provide the opportunity to re-evaluate current practices and serve as a forum for improvement.
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.