Data compliance is the process of arranging classified data in accordance with business standards and governing regulations. Every client, customer, employee, and contractor encounters your business brings a wealth of Personally Identifiable Information (PII) considered as sensitive data. It is the responsibility of an organization to safeguard sensitive data in compliance with local and global regulations. Data compliance is ensuring sensitive data is managed and organized so that organizations meet enterprise business rules along with legal and governmental regulations.
Health data is regulated within and across countries through regulations such as the Health Insurance Portability and Accountability Act (HIPAA), ISO 27701, and the General Data Protection Regulation (GDPR). Many life sciences companies may also have to meet data compliance requirements that comply with additional regulations from the Food and Drug Administration (FDA) and Medicines & Healthcare products Regulatory Agency (MHRA) that focus on cGMP, GxP systems and applications. Good Manufacturing Practice (cGMP) and good practice (GxP) requirements allow for strategies to manage data integrity and data compliance.
Arbour Group’s Data Compliance Services
At Arbour Group, whether it is Data Integrity Plan Development, Data Assessment Regulatory Compliance, or Validation and Testing, we can help you achieve your Data Compliance goals. Our approach will help you understand your data management maturity level, obligations, validation, and remediate audit findings. Arbour can assist your organization with the proper framework, regulatory requirements, and organizational change management that provides a holistic, proven, multi-pillar view of data management across process, people, and technology.
For more information on Arbour Group’s Data Compliance Services, contact us today!
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.