A leading commercial business software now has a pre-packaged Infor ERP validation solution for the life sciences industries. If you are newly implementing or planning an upgrade to Infor, validation is now available as a fixed-price package.
The Arbour Advantage
Licensed, sold, and supported by Arbour Group, the pre-packaged Infor ERP validation
solution is based on extensive industry knowledge and expertise accumulated from years of experience with leading pharmaceutical, medical device, and biotechnology companies. Arbour Group’s Infor compliance product allows you to meet your obligations to both domestic and international authorities (e.g. FDA, HPRA, MHRA, EMA, and TGA) in a timely and cost-effective manner.
Infor Compliance Offering
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 Infor ERP validation product, maintenance program, and industry professionals combine to form a comprehensive Infor compliance solution.
The Arbour Assurance
This Infor validation product assures you the maximum protection in your investment by providing the following primary benefits:
Shorter Timeframes: Our time-tested, field-proven pre-packaged Infor ERP validation product certifies compliance in an optimally expedient and secure manner. This means you are able to 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 as it relates to Agency approval of new product introductions and brand acceptance in the marketplace.
Whether you are installing Infor for the first time, converting from a legacy system or implementing a release, Arbour Group’s pre-packaged Infor ERP validation product will help you manage your business risk quickly and reliably.
CloudSuite Industrial Compliance
Companies throughout the life sciences industry are using CloudSuite Industrial to manage their end-to-end operations. As their ERP needs range from financials to analytics, they can manage their ETO, MTO, MTS, and mixed-mode manufacturing. Clients also have the option of deploying highly flexible architecture on-premise or in the Cloud. An ideal solution for both discrete and process manufacturers; the ERP includes predictive analytics, collaboration, lean production tools, and integration options.
Clients rely on CloudSuite to improve their service to customers, expand their quality and production, effectively harmonize aftermarket service, and develop in collaboration. Although the solution has full redundancy and disaster recovery systems in place to defend against intrusion, hacking, and unofficial access, it does not validate itself to prove it is working to its intended use. In order to prove to international agencies that the CloudSuite solution is validated, the necessary software testing and documentation must be executed. Whether running on-premise or in the cloud, Arbour Group provides the necessary expertise to assist an enterprise with their global regulatory needs.
Infor LX (BPCS) Compliance
Small to large manufactures depend on Infor LX (BPCS) in every phase of process and discrete manufacturing business processes. The needs for manufacturers in the Life Sciences ranges from source-to-pay, prospect-to-cash, design-to-manufacture, and financial tracking and reporting. Running LX Cloud gives the advantage of running an IBM i-based enterprise resource planning system with the option to integrate with Infor’s application in the supply chain, Supplier Exchange solutions, and more.
The IBM platform gives manufacturers the scalable and protected system whether run on-premise or in the cloud. Even with a dependable IBM power system, the necessity of validation is still a key issue in the Life Sciences. Demonstrate to the FDA and other international agencies that no matter the type of manufacturing method that is being implemented, from batch to flow and lean, your system is validated with regulatory requirements in mind. Arbour Group has the pre-packaged solutions to best benefit your company’s integrity with warranted deliverables.
Infor LN Compliance
The Enterprise Resource Planning (ERP) cloud solution for intricate multi-site companies to single-site companies, Infor LN has the proficiencies to meet the unique requirements of manufacturers. From service management to financials, Infor LN provides real-time data to improve communication with business partners in the Life Sciences industry. Clients have the benefit of business process optimization with end-to-end supply chain visibility.
With business methods based on industry-specific best practices, Infor LN is compliant in 49 countries. However, manufacturers in the Life Sciences are responsible for FDA and other international agency requirements that are not included in Infor LN’s capabilities. Partner with Arbour Group and receive the necessary regulatory documentation that assures a safety net of validation in your industry. Attest to your business partners that your Infor LN software is validated, whether run on-premise or in the Cloud.
Infor M3 Compliance
Medium to large global life sciences manufacturers, distributors, and after-sales service providers are using Infor M3 to manage their mixed-mode and complex value chains. With industry detailed functionality and flexible deployment, multisite enterprises are using Infor M3 in the Cloud or on-premise deployment. Clients prefer industry-specific suites and cross-industry applications that support complex business processes from customer sales to equipment management.
Although Infor M3 provides role-based insights and critical alerts to its customers, it does not alert to regulatory requirements unique to the Life Sciences industry. With its multi-faceted capabilities as an international enterprise resource planning solution platform, the software must be validated to its intended use to meet any applicable regulatory requirements. Arbour Group’s long-standing expertise in validation deliverables can assist your life science company in compliance.
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.