Driving Innovation while Reducing Time to Market
Life science companies maneuver a highly competitive market that is challenged with complex processes and strict regulatory requirements. Time-to-market is critical in order to meet changing customer demands. Whether your business operates in pharmaceuticals, nutraceuticals, biotechnology or medical devices, it requires the right technology framework that drives agility, compliance, and growth.
Arbela Health solutions enable companies to build a foundation for success with technology that supports the entire life science journey – from research and development to commercial manufacturing. Our solutions combined with deep industry expertise provide life science organizations with the tools to successfully manage finance, distribution, production, quality management, and more – all while maintaining compliance and adhering to FDA/GxP validation requirements.
Built on Microsoft Dynamics, Arbela Health offers:
- Product traceability - Clinical trial cost management - In-house or contract manufacturing
- Lot, batch, serial, and - Restricted sales and expense - Best-of-breed solution
container tracking management development
- Item creation and change - 21 CFR Part 11 or other FDA - 3rd party logistics integration
approval Validation requirements
- Approved vendor, customer, - Documented business processes - Adherence to Good Manufacturing
and manufacturer lists standard operations procedures
- Advanced quality control - Security roles and restrictions
Financial Management, Inventory Control and Production Management throughout your journey to Commercial Manufacturing
Arbela Health supports your business throughout the entire life science journey from research and development to a fully validated commercially released product. The solution supports mixed mode manufacturing - process and discrete - in the same database allowing you to reduce costs by optimizing inventory levels, minimizing overstock and expired item waste.
Early-Stage Trial Management
Arbela Health enables you to track your trials, budgets, expenses, sales and marketing costs. Utilizing project management within Microsoft Dynamics 365, tracking your costs is a simple task. Segment your financial costs for more in-depth reporting and control your budget versus actuals. Integration with procurement enables policy-driven workflow approvals for all purchases - directly posted against your project.
Inventory Control and Quality Compliance Throughout Your Journey
In a heavily regulated environment, lot and serial traceability is critical. Arbela Health enables you to track from source material through manufacturing and distribution. Whether you are manufacturing in-house or outsourcing, quality control is paramount. From quality tests, quality orders, and non-conformance reporting, we have you covered. Arbela can help you maintain your FDA (GxP) validation standards.
From fulfillment and integration with 3PL and full EDI capabilities to FDA validation, Arbela Health readies you for commercializing your products. Arbela can help you comply with The Sunshine Act with sales expense tracking which may be a required capability for you. Arbela Health helps with itemizing expenses and policy enforcement and reporting.
Security and Compliance for When You Go Public
Arbela's Audit & Security Manager supports SOX 404 compliance around segregation of duties (SoD) as well as financial SOX compliance. Control security access and data integrity across your organization with pre-packaged with reports to support your year-end audits.
Successful Mergers and Acquisitions
Mergers and acquisitions have historically shaped the life sciences industry into what it is now and continues to shape the future of the industry. Your company may have to change its way of thinking to create more value in the market, drive more revenue, create new technology, and disrupt the competitive landscape - while trying to maintain systems to manage their operations. These integral business systems should not impact your company’s ability to integrate a new business or be integrated into a new company. Arbela Health and Microsoft Dynami
Arbela Health Validation Package Jumpstart
Benefits of a Validated Solution:
Software validation is a critical tool used to assure the quality of ERP software. Software validation can increase the usability and reliability of the device or drug, which could result in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers or pharmaceutical manufacturers.
ERP software validation can reduce longer term costs by making it easier and less costly to reliably deploy and maintain the software, as well as revalidate software changes. An established comprehensive software validation process can help to reduce the long-term cost of software and maintenance by reducing the cost of validation for each subsequent release of the software.
The Arbela Health FDA Validation Package includes: