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The leading cloud computing software has a pre-packaged NetSuite ERP validation solution for the life sciences industries whether implementing or planning an upgrade, validation for this cloud-based business management platform is available as a fixed-price package.

The Arbour Advantage

The pre-packaged ERP system validation solution is based on Arbour Group’s extensive industry knowledge and expertise from years of experience with leading pharmaceutical, medical device, and biotechnology companies. Arbour Group’s NetSuite compliance product allows you to meet your obligations to domestic and international authorities (e.g., FDA, HPRA, MHRA, EMA, and TGA) in a timely and cost-effective manner

Oracle NetSuite Compliance Offering

As an alternative to manual, labor-intensive validation efforts, Arbour Group’s ready off-the-shelf ERP system 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

One Database, One System—Oracle NetSuite

Oracle NetSuite implementation for organizations in the Life Sciences provides a customized Cloud software system as business demands evolve. The NetSuite Cloud delivers the flexibility to pharmaceutical, biotechnology, medical device, and diagnostic industries using a NetSuite Enterprise Resource Planning (ERP) system, NetSuite Customer Relationship Management (CRM), or NetSuite Professional Services Automation (PSA).  Upgrades and configurations adapting to new business models must address compliance standards set by international agencies. Whether undergoing NetSuite integration for the first time or initiating new updates, Oracle NetSuite must adhere to strict Life Science regulations.

NetSuite Validation Best Practices 

Life sciences validation of NetSuite functionality demands a thorough plan that satisfies business processes and regulatory requirements. A comprehensive validation plan necessitates a tailored approach that addresses your business risk concerns. 

Validation ScopeThe validation scope identifies critical NetSuite functionality particular to the life sciences. The scope addresses which modules and features will be tested for compliance and what data, processes, and integrations are integral to NetSuite validation testing. 

Risk Assessment: A compliance risk assessment assists in prioritizing validation efforts by addressing regulations like 21 CFR Part 11, Annex 11, and GxP guidelines that affect NetSuite functionality. NetSuite software validation protocols and test cases must align with applicable regulatory standards for life science companies to help identify high-risk areas requiring stringent validation testing. Identified risks are mitigated through testing and related procedural controls.  

Validation Protocols: A NetSuite validation protocol outlines test objectives, procedures, acceptance criteria, and responsibilities. Comprehensive test cases are created to cover functional and end-to-end processes as well as security/access control and audit trails, while addressing regulated business processes like order management, inventory tracking, and traceability. 

Test Execution: Validation testing is executed according to a company’s defined protocols to document test results, including any system deviations. Regression testing ensures there are no adverse impacts on existing NetSuite functionalities. 

Documentation: Comprehensive documentation of validation testing includes test cases, test results, and deviations to maintain NetSuite regulatory compliance. A validation summary report highlights a system's compliance status and details how compliance will be maintained.  

Validation Maintenance Plan: Address system updates and patches by monitoring system changes that affect compliance. As business requirements evolve, it is essential to incorporate changes to the validation process. Implementing regulatory change control ensures compliance with growing regulatory requirements while monitoring critical NetSuite functionality. 

Stakeholder Engagement and Training: Key decision makers from IT, quality assurance, and end-user groups are necessary during the NetSuite software validation process. Adequate training further ensures users understand the regulatory standards that affect NetSuite functionalities.  

How Life Sciences Benefit from NetSuite

Life Sciences companies implement NetSuite because of its scalability and ability to accommodate growing company needs. The flexibility in modular architecture allows Life Sciences to customize and tailor the system to their specific requirements, ensuring that it aligns with their unique business processes. NetSuite provides real-time insights with robust reporting and analytics capabilities that provide real-time insights into key performance metrics, enabling data-driven decision-making across all aspects of operations.

NetSuite benefits Research and Development (R&D) by providing robust project management tools that enable life sciences companies to efficiently manage R&D projects, including budgeting, resource allocation, and timeline tracking. Its cloud-based platform facilitates collaboration among R&D teams, allowing them to share data, documents, and insights in real time, regardless of geographical location.

NetSuite assists Supply Chain Management with an integrated inventory management system that helps life sciences companies optimize inventory levels, ensuring the availability of critical supplies while minimizing excess stock. NetSuite enables efficient order processing and fulfillment, crucial for maintaining uninterrupted supply chains in the life sciences. 

NetSuite offers robust tools for managing quality control processes and assisting with compliance with industry regulations and standards, such as Good Manufacturing Practice (GMP) and ISO standards. NetSuite’s integrated approach enables comprehensive audit trails, providing transparency and traceability of quality processes and facilitating regulatory audits.

NetSuite's regulatory reporting capabilities enable life sciences companies to generate and submit reports accurately and efficiently, helping them adhere to complex regulatory requirements. NetSuite’s document management features facilitate the organization, storage, and retrieval of regulatory documents, ensuring compliance with documentation requirements.

NetSuite Regulatory Compliance Considerations

Regulatory compliance requirements in the life sciences industry are particularly stringent, covering various aspects like data management, traceability, and adherence to industry-specific regulatory standards. NetSuite, a cloud-based enterprise resource planning (ERP) solution, offers several features and functionalities that cater to the industry's unique compliance needs.

Life sciences handle sensitive data related to clinical trials, patient information, research data, and intellectual property. NetSuite provides robust data management capabilities that include role-based access controls, encryption, and audit trails to ensure the security and integrity of sensitive information. Life sciences adhering to the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR) requirements benefit from NetSuite’s attention to securing data. 

Traceability is crucial for tracking products and materials implemented in the supply chain, from raw materials to finished products. NetSuite's inventory management and serialization capabilities assist in maintaining detailed records of product batches, expiration dates, and distribution channels. Traceability features help maintain NetSuite's FDA Compliance. 

Life sciences companies must adhere to regulatory standards such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP). NetSuite users implement configurable workflows and functional modules that can be tailored to meet life science standards and facilitate adherence to all regulatory requirements. NetSuite's reporting and analytics capabilities enable companies to generate necessary compliance reports to demonstrate regulatory compliance during audits and inspections.

Oracle NetSuite Cloud Validation with Arbour Group

NetSuite’s Cloud infrastructure runs scaled management solutions from e-commerce to ERP to assist the Life Sciences with manufacturing and supply chain needs. NetSuite’s Cloud ERP system has comprehensive data privacy and data management security, but it does not mitigate regulatory standards set by the FDA and other international agencies. Accelerate growth and drive innovation by addressing compliance risks to prevent business disruptions. Arbour Group’s NetSuite compliance consultants can assist in validating your NetSuite Cloud system.  Arbour can also help with Quality Agreements, IT supplier audits, and Procedural Controls to ensure compliance with your entire cloud ecosystem. Pre-packaged to fit your business needs, our cloud validation solutions are customized to meet your Life Science requirements.

NetSuite Full Maintenance Program

Licensed Product Support is a maintenance program that ensures integrity in validation documentation for Arbour Group enterprise software compliance packages and deliverables. Updated documentation is provided with NetSuite regulatory compliance expertise that ensures an ongoing compliant environment. Collectively, our pre-packaged NetSuite ERP validation product, maintenance program, and industry professionals combine to form a comprehensive NetSuite compliance solution.

The Arbour Assurance

This NetSuite 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 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 installing NetSuite 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.

NetSuite: Frequently Asked Questions

What makes NetSuite an ideal ERP solution for life sciences companies?

Cloud-based allows for flexibility for life sciences that may have multiple locations, remote teams, or need to access data in the field or during clinical trials. NetSuite's scalability allows companies to quickly adapt and expand their operations without significant IT infrastructure investments or disruptions to their business processes as companies experience growth, especially as they move through different stages of product development, clinical trials, and commercialization. 

How does NetSuite help ensure compliance with life sciences regulations?

NetSuite doesn't directly enforce cloud ERP compliance; it provides tools and capabilities that assist in implementing and maintaining compliance with regulations like the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). NetSuite’s document management system assists with storing and managing regulatory documents like FDA submissions, clinical trial data, and quality management documents, ensuring necessary documents are accessible for audits and inspections. NetSuite’s quality management features help enforce quality control processes under regulatory requirements. While NetSuite offers functionality to assist with regulations pertinent to the life sciences, companies must understand their specific regulatory requirements and ensure NetSuite is configured and implemented to align with them.

Can NetSuite be customized to fit specific processes within my life sciences organization?

NetSuite is flexible and customizable, allowing for a tailored approach to software that meets a company's unique requirements and workflows. From custom fields and forms to integration with third-party applications, NetSuite’s customization capabilities adapt to the processes life sciences need to optimize their workflows and improve efficiency. 

What are the key benefits of using NetSuite for life sciences ERP solutions over other systems?

Life Sciences companies with multiple locations or that need remote access to data for real-time collaboration and decision-making benefit from a cloud-based solution like NetSuite. NetSuite offers a comprehensive suite of business management applications that can include financials, inventory management, and Customer Relationship Management (CRM) that integrates with ERP capabilities. 

How does NetSuite handle data security and privacy, especially for sensitive life sciences data?

NetSuite helps prioritize data security and privacy of sensitive data in the life sciences. Data encryption, role-based access controls (RBAC), and audit trails assist organizations with monitoring suspicious activities, investigating security incidents, and demonstrating compliance with regulatory requirements.

How does NetSuite support international operations for life sciences companies?

NetSuite for life sciences helps comply with regulatory requirements in different countries, including requirements for labeling, product registration, quality assurance, and clinical trials. NetSuite can be configured to support specific regulatory frameworks and requirements in various international regions.

Can NetSuite integrate with other systems and tools commonly used in life sciences?

Integrations with NetSuite enable life sciences to streamline processes, improve data accuracy, and help enhance collaboration across a company’s ecosystem of applications. From Laboratory Information Management Systems (LIMS), Electronic Data Capture (EDC) Systems, or Quality Management Systems (QMS), NetSuite’s flexible integration capabilities assist life sciences looking to connect a range of systems that enable a seamless data flow and exceptional process automation.

What kind of support and maintenance does NetSuite offer for life sciences clients?

NetSuite proactively monitors security vulnerabilities and threats by releasing patches and updates to help ensure the security and integrity of client data. Life sciences have access to the latest improvements to help meet industry regulations and standards, like GDPR, HIPAA, and FDA compliance NetSuite requirements.

How does NetSuite help facilitate regulatory audits and inspections in the life sciences industry?

NetSuite offers document management capabilities that allow life sciences to securely store, organize, and manage regulatory documents, including FDA submissions, clinical trial data, quality management documents, and standard operating procedures (SOPs). Authorized personnel have access to relevant documents to demonstrate compliance with regulatory requirements during audits and inspections. 

Contact us today to further discuss the questions and answers surrounding NetSuite ERP validation. 

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