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The leading mid-market commercial software has a pre-packaged validation solution for the life sciences industries. If you are implementing or planning an upgrade to SAP Business ByDesign, validation for this cloud-based business management software is now available as a fixed-price package.

The Arbour Advantage 

Licensed, deployed, and supported by an SAP Business ByDesign (SAP ByD) partner, the pre-packaged cloud ERP validation solution is based on Arbour Group’s extensive industry knowledge and expertise accumulated from years of experience with leading pharmaceutical, medical device, and biotechnology companies. The Arbour Group SAP Business ByDesign compliance product allows you to meet your obligations to domestic and international authorities (e.g., FDA, MPRA, MHRA, EMA, and TGA) in a timely and cost-effective manner.

SAP Business ByDesign Compliance Offering

As an alternative to manual, labor-intensive compliance efforts, Arbour Group’s ERP system validation for the life sciences 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. Collectively, our pre-packaged cloud ERP validation product, maintenance program, and industry professionals combine to form a comprehensive SAP ByD compliance solution.

The Arbour Assurance

This SAP Business ByDesign validation product guarantees 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 expediently and securely. This allows organizations to accelerate the time-to-value of their commercial business software investment.

Regulatory Agency Approval: Properly validated solutions are more likely to avoid regulatory scrutiny through citations and audits. These time-consuming and disruptive events can pose a business risk related to agency approval of new product introductions and brand acceptance in the marketplace.

Whether installing SAP Business ByDesign for the first time, converting from a legacy system, or implementing a release, Arbour Group’s pre-packaged validation product will help you manage your business risk quickly and reliably.

SAP Business ByDesign (SAP ByD) Software

SAP Business ByDesign is an enterprise resource planning software solution located in a single cloud for mid-market companies in the Life Sciences—a comprehensive choice for companies that prefer a scale-to-model approach. From Human Resources to Supply Chain Management, SAP ByD can be customized to your unique business processes and solutions. SAP provides guidelines, tools, and training support to maintain security throughout their product’s life cycle.

Key Features and Benefits of SAP ByD for Life Sciences

Scalability: As a life sciences company expands, SAP Business ByDesign customization provides scalable capabilities for operations adapting to growing business needs without major system interruptions.

Cloud-Based Architecture: SAP ByD provides real-time analytics and reporting capabilities, allowing real-time insights into life science operations, optimizing processes, and influencing knowledgeable decisions.

Comprehensive Modules: SAP ByD is a unified platform that integrates life science business processes like sales, finance, and manufacturing to benefit efficiency and ensure effective operations across company departments.

Compliance Management: SAP ByD implements tools that track and adhere to industry-specific regulations and standards, assisting in maintaining regulatory requirements in a highly regulated life sciences environment.

Data Security in SAP ByD Benefits: SAP ByD has Role-Based Access Control to ensure employees have the appropriate access to data and functions necessary to their roles, reducing the risk of unauthorized access. Data encryption protects sensitive data during transmission between users and systems and when stored in databases to prevent unauthorized access. Organizations can specify data residency requirements to store data in compliance with applicable regulatory requirements.

All-in-One Validation Solution for SAP Business ByDesign

How can you test and confirm that the software works within its intended uses? Demonstrate to FDA and international regulatory agencies that your SAP software is working adequately within guidelines by using Arbour Group’s software validation product and services. SAP ByDesign releases quarterly version updates of their software to meet growing customer needs as technology evolves. Enhancements to the functionality of applications, such as supply chain management, affect how the software works and if it is still working to its intended use. For example, if SAP releases improvements in the production order process, it is the company's obligation to ensure the implementation of new updates is properly sustained in their software. The Arbour Group pre-packaged SAP Business ByDesign solution and maintenance program is a support scenario that will meet industry and compliance needs when software solutions release new updates and releases.

In-Depth Validation Package Details

Business Requirements Model (BRM): BRM involves documenting and analyzing an organization’s business requirements by aligning them with relevant regulations and compliance standards, ensuring that operations adhere to the appropriate life science requirements. BRM assists life science organizations in updating and modifying business requirements in response to regulatory changes, ensuring ongoing compliance, and assisting in effective change management. A Business Requirements Model identifies risks associated with regulatory non-compliance and integrates the appropriate controls to minimize compliance breaches. A BRM offers clear objectives, prioritization of needed requirements, consistency of standardized business processes, improved communication among departments, and efficient resource allocation. A BRM is a foundational tool for maintaining regulatory compliance that enhances operational efficiency by providing clarity, traceability, and adaptability to changing business needs.

The Validation Plan Template: a template that outlines the approach, processes, and activities for validating software systems within a life sciences organization. A validation plan template documents the validation process, including testing procedures and acceptance criteria. The documentation is necessary evidence for regulatory audits, demonstrating that the organization has followed a structured compliance approach to validating systems and processes. A validation plan identifies potential risks associated with the system, helping organizations mitigate risk while ensuring compliance with regulatory expectations. The validation plan template refers to change control provisions and evaluating relative process risks. The template helps streamline the validation process to make it more efficient and to reduce the likelihood of errors and oversights. A template also clearly defines roles and responsibilities so team members understand their roles in the validation process.

Test Scripts: test cases and their appropriate regulatory compliance requirements are clearly defined to provide a record of how testing is conducted. Test scripts provide evidence that each regulated process works as configured. Test script validation of critical processes is essential for demonstrating compliance with industry standards and regulations. Test scripts are updated and executed when changes are made to regulated processes. Any resulting modifications must adhere to written change control procedures required in regulatory compliance. Test scripts provide a consistent approach so that testing procedures are followed across different projects and teams, reducing the likelihood of errors and inconsistencies. Well-designed test scripts facilitate efficient test execution that meets project timelines and maintains operational effectiveness. Early detection of issues uncovered by the validation process helps promptly address compliance issues, reducing the chance of costly delays to the project lifecycle.

Regulatory Compliance with Arbour Group

Arbour Group assists life sciences in a complex regulatory environment while navigating regulation shifts and evolving requirements. Arbour Group evaluates where an organization needs compliance assistance, articulates the current compliance status, and helps implement strategies for improvement. Customized compliance plans provide documentation outlining refined policies and procedures tailored to meet specific regulatory requirements.

Arbour Group training programs educate life science employees on relevant regulatory requirements and best practices so that everyone understands compliance expectations and their roles in compliance maintenance. Arbour Group assists in implementing compliance initiatives so that integrating new processes and controls benefits regulatory requirements.

Arbour Group can conduct periodic reviews (audits) to assess whether an organization maintains compliance. Arbour Group can develop remediation plans that address compliance issues and recommended compliance actions. Thorough documentation provides accurate information to demonstrate compliance during regulatory audits or inspections.

Compliance Maintenance

Ensure validation documentation integrity with Arbour Group’s Licensed Product Support for enterprise software compliance packages and deliverables. Periodic reviews of validation documentation identify discrepancies to ensure documentation remains accurate and maintains compliance.  

As SAP releases software updates, it is essential to maintain compliance and stay informed with changing industry regulations and legal obligations. Updated documentation is provided in conjunction with regulatory compliance expertise that ensures an ongoing compliant environment. Together, Arbour Group’s pre-packaged validation package, maintenance program, and industry professionals form a comprehensive SAP ByD compliance solution.

SAP Business ByDesign For Life Sciences: Frequently Asked Questions

How does SAP Business ByDesign cater to the specific needs of life sciences companies?

SAP Business ByDesign for life sciences ERP solutions provides detailed documentation that includes traceability, a crucial component when maintaining regulatory compliance. Quality control features monitor product quality through the supply chain process, while batch management ensures compliance with regulatory requirements.

What makes Arbour Group’s validation package for SAP ByD unique in ensuring compliance?

Arbour Group’s pre-packaged SAP Business ByDesign solution is delivered by validation and verification experts in 21 CFR Part 11 compliance requirements. Our specialists stay current on changing regulatory requirements and emerging technologies when assisting life science organizations with compliance maintenance.

How does SAP ByD support regulatory audits in the life sciences industry?

SAP ByD delivers comprehensive audit trails that reflect each transaction or change made within the system, giving a detailed record of activities. An audit trail assists in demonstrating compliance during regulatory audits.

Can SAP Business ByDesign be integrated with other life sciences-specific systems and tools?

SAP ByD can be configured to facilitate an efficient workflow. Seamless integration is determined by adhering to system capabilities and addressing regulatory requirements.

What are the key benefits of choosing SAP ByD over other ERP systems for life sciences?

SAP ByD supports life science industries adhering to evolving regulatory requirements. SAP ByD has dedicated capabilities to documentation, quality management, batch processing, and traceability, assisting companies in maintaining regulatory compliance in cloud ERP systems.

Contact Arbour Group to discuss validation of cloud-based ERP for life sciences.