Bringing medical, pharmaceutical and biopharmaceutical products to market is a complex and high-risk race. The inherent threats of this industry require vast resources to successfully hit the market. The need to comply with an increasing number of regulatory guidelines has been an issue for quite a while.
At Arrayo, compliance management is achieved through the definition of compliance management processes which identify the applicable requirements, assess the state of compliance, assess the risks and potential costs of non-compliance against the projected expenses to achieve compliance, and then prioritize, fund and initiate any corrective actions deemed necessary.
As more stringent regulations continue to impact and dictate quality management decisions in industries such as pharmaceuticals and medical device, it is becoming increasingly important to manage and control increasingly complex compliance risks.
At Arrayo, we help you build a common framework and an integrated approach to manage all compliance requirements and control initiatives across the entire organization. We support you in centralizing, streamlining and standardizing quality process data and content from the whole value chain, providing those accountable for making decisions with a rounded perspective that would otherwise be hard to gain.
Our assignments span from Quality Systems implementation including Audit, Assessment, CAPA, Change Control, Non Conformance, Deviation, Investigations, Environmental Monitoring to Customer Complaints.
We provide services that cover all stages of the life cycle of a computerised system in order to meet audit and regulatory requirements. Our computer system validation (CSV) consultants can help you define and standardize your CSV policies and procedures, perform audit readiness assessments, identify compliance gaps and provide advice on process improvement and remedial actions.
We support you in designing enterprise-wide Change Control systems so you can keep your validated systems under control and comply with change management regulations. We also help in initiating and owning Change Control Records to introduce changes in a controlled and coordinated manner that minimize disruption to production schedules while ensuring compliance with industry regulations. Arrayo accompanies your organization in designing, standardizing and implementing Change Control across the whole process, from change request to implementation of the change.
At Arrayo, we uniquely combine industry knowledge, science, analytics and IT expertise which allow for high positive impact assignments on business performance.
We combine functional and technical expertise to build the teams who will ensure risk management and regulatory demands are met, using the best-of-breed technologies and analytical applications.