The leading commercial business software now has a pre-packaged validation solution for the life sciences industries. If you are newly implementing or planning an upgrade to Oracle ERP Cloud, validation is now available as a fixed-price, pre-written packaged solution.
Arbour Group's Oracle ERP Solution
Licensed, deployed, and supported by an Oracle ERP Cloud partner, the pre-packaged validation solution is based on Arbour Group’s extensive industry knowledge and expertise accumulated from years of experience with pharmaceutical, medical device, and biotechnology companies. Arbour Group’s Oracle ERP Cloud compliance product allows you to meet your obligations to both domestic and international authorities (e.g., BfArM, FDA, HPRA, MHRA, and TGA) in a timely and cost-effective manner.
ERP System Compliance
As an alternative to manual, labor-intensive validation efforts, Arbour Group’s ready off-the-shelf validation package incorporates industry compliance best practices to include:
- Business Requirements model
- Validation Plan template
- Traceability Matrix
- Installation Qualification test scripts
- Operation Qualification test scripts
- Performance Qualification template
- Validation Summary Report template
Full Maintenance Program
Licensed Product Support is a maintenance program that assures validation documentation integrity for Arbour Group enterprise software compliance packages and deliverables. Updated documentation is provided in conjunction with regulatory compliance expertise that ensures an ongoing compliant environment. An Annual Regulatory Assessment and other benefits are included. Collectively, our pre-packaged validation product, maintenance program, and industry professionals combine to form a comprehensive Oracle ERP Cloud compliance solution.
Oracle ERP Cloud Compliance
Oracle ERP is a cloud-based enterprise resource planning solution used to automate processes and daily business activities. Oracle ERP software ties together business processes like project management, accounting, procurement, risk management, compliance, human resources, and supply chain operations. Organizations in the Life Sciences implement Oracle to unify fragmented systems to save money, improve collaboration between team members, have improved analytics and productivity, and simplified compliance and risk management. While monitoring compliance at every cloud system level, Life Science companies need to address complete ERP system validation.
Validating Your Oracle ERP Cloud Solution
Whether in the cloud or on-premise, enterprise resource planning software in the Life Sciences must be validated to maintain agency regulatory requirements. Oracle ERP software complies with industry-specific data practices and commits to a compliant virus scan interface dedicated to increasing cloud system security. However, Oracle cloud does not have the responsibility to ensure regulatory software compliance; that is the responsibility of the organization implementing the enterprise resource planning solution. Arbour Group has the global regulatory expertise to deliver high-quality consulting services to Life Sciences companies.
The Arbour Assurance
This Oracle ERP Cloud validation product assures you the maximum investment protection in your investment by providing the following primary benefits:
Shorter Timeframes: Our time-tested, field-proven pre-packaged validation product certifies compliance in an optimally expedient and secure manner. This means you can accelerate the time-to-value of your commercial business software investment.
Regulatory Agency Approval: Properly validated solutions are more likely to avoid regulatory scrutiny in the form of citations and audits. These time consuming and disruptive events can pose a real business risk related to Agency approval of new product introductions and brand acceptance in the marketplace.
Whether you are installing Oracle ERP Cloud for the first time, converting from a legacy system, or applying a patch, Arbour Group’s pre-packaged validation product will help you manage your business risk quickly and reliably.
If you require an Oracle ERP consultant and would like further to discuss Arbour Group’s ERP Cloud software validation services, talk to 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.