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.
What is Cloud Compliance?
Cloud compliance is ensuring cloud computing services are met and cloud security is secured while adhering to internal best practices and the regulations set by governing agencies and industry organisations. Using the cloud to execute various functions has created endless possibilities and significant industry developments. Whether you are considering migrating applications, data, or combined infrastructure, deciding to migrate to the cloud initiates the issue of meeting compliance. Cloud compliance standards are important to keep in highly regulated industries to meet agency requirements and assist in assuring cloud computing security to protect cloud infrastructure, applications, and data.
In the Life Sciences, industry-standard policies like Health Insurance Portability and Accountability Act (HIPAA), International Organization for Standardization (ISO), and regulatory bodies like the Federal Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medical Agency (EMA) impact how companies operate in the cloud and are held to explicit cloud compliance standards. For example, migrating Current Good Manufacturing Practice (cGMP) systems to the cloud is more complicated than migrating non-cGMP systems. Similarly, cloud compliance mandates impact the healthcare industry set by organisations like the Centers for Medicare and Medicaid (CMS) and Health and Human Services (HHS).
Arbour’s Agile Cloud Compliance Services
At Arbour Group, whether the issue is governmental, legal, customer, or industry-driven, we can help you achieve your cloud compliance goals. Agile method implementation ensures that your applications, data, infrastructure, platform, and Software as a Service (SaaS) validation packages remain compliant. Furthermore, if your goals include Validation Assessments or obtaining Health Information Trust Alliance (HiTrust) certifications, we have the expertise to ensure your success.
Our partnership with major cloud service providers, combined with our cloud compliance solutions, helps maintain your compliance standards. Many organisations incorrectly believe the cloud vendor is solely responsible for maintaining security and compliance. With cloud host providers, the customer and the vendor have a shared responsibility to maintain compliance. Furthermore, hybrid and private cloud environments pose additional challenges that also need to be addressed.
In-Depth Cloud Compliance Deliverables
Arbour Group has the knowledge and expertise to work with your organisation to execute a sound cloud compliance strategy, including data storage, server location, identity and access management, and data protection. Our compliance approach supports your cloud-based software application by ensuring a high level of compliance for the entire cloud ecosystem to include the following:
- Cloud Security focuses on the policies, technologies, and controls that protect cloud data, infrastructure, and services associated with cloud computing
- Procedural Controls cover critical regulatory processes with established measures and documentation
- Quality Agreements define duties and responsibilities to reduce regulatory risk and ensure compliance
- Software Validation deliverables backed by our Maintenance Program
- IT Supplier Audits ensure vendor practices and procedures are compliant and follow company guidelines
- - Master Validation Plan
- - User Requirements and Specification
- - Risk Assessment
- - Requirements Trace Matrix
- - Test Protocols
- - Execute Test Scripts
- - Validation Summary Reporting
- - Software Developer
- - Data Center
As a trusted provider of global regulatory solutions for over 250 life sciences companies, Arbour Group delivers the documented evidence necessary to meet cloud applications’ regulatory requirements and GDPR compliance. Our experience and comprehensive services ensure cost-effective compliance in today’s world of ever-changing technology and regulations.
For more information on Arbour Group’s Cloud Compliance Services in Europe, 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.