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Oncopeptides
Public Pharmaceutical Company Developes Smart, Audit-Ready Procedures from Scratch with Netwrix Strongpoint
20 +
Years in the industry
Listed in
Stockholm Stock Exchange
Strongpoint will definitely help us avoid major risks around product validation.
David Jarrell, Senior NetSuite Consultant at Viking Resources
Challenge
Preparing for Rigorous Audits. As a publicly traded pharmaceutical company, Oncopeptides needed to avoid the informal methods for tracking changes, as they posed significant audit risks. The lack of a formalized, automatic change management system made ensuring compliance and integrity in their records challenging, increasing the workload during audit periods.
Managing a Complex, Multinational Team. The process of customizing Oncopepdite’s new NetSuite implementation involved inputs from a dispersed team across North America and Sweden, along with multiple consultants. This setup made it difficult to manage changes efficiently, as they initially relied on spreadsheets and informal communication for tracking changes and approvals.
Balancing Transparency with Rapid Change: The customer needed to maintain a high level of transparency for audits while also adapting quickly to changes in their fast-paced industry. This dual requirement was challenging because rapid changes often complicate documentation and compliance processes.
Our company was up and running with Netwrix Strongpoint in under three weeks — making sure we were able to meet our go-live date and laying the groundwork for a fully validated system that could produce ITGC-ready change logs on demand.
David Jarrell, Senior NetSuite Consultant at Viking Resources
Netwrix Solution
Oncopeptides needed to balance rapid industry changes with strict transparency requirements for auditors. Facing the complexity of managing frequent updates across dispersed teams and systems, they decided to implement Netwrix Strongpoint.
Automated Change Management System. Netwrix Strongpoint implemented a computerized system that tracks all user changes within NetSuite. This system replaced Oncopeptides' informal processes, such as spreadsheets and email approvals, ensuring a more reliable and transparent method of tracking changes. This automation dramatically simplifies audit processes by providing clear, real-time documentation and accountability, directly addressing the challenge of maintaining transparency amidst rapid industry changes.
Comprehensive Documentation and Smart Policies. Strongpoint deployed its 'Spider' tool to create detailed, continuous documentation of all customizations and interdependencies in Oncopeptides’ NetSuite environment. This setup included innovative policies that classify changes by risk level and automatically conduct impact analyses to determine which changes require additional approvals or investigations. This solution effectively manages the complexity of having a geographically dispersed team and multiple consultants, making the customization process more manageable and less prone to errors.
Streamlined Validation and Compliance. Netwrix Strongpoint enabled Oncopeptides to produce IT general controls-ready change logs on demand, supporting compliance with regulatory requirements. The system also allows the team to generate and approve change requests entirely within NetSuite, create audit-ready logs of all changes, and automatically apply impact analysis to proposed changes. This comprehensive approach ensures that Oncopeptides can meet their audit requirements with less effort and more accuracy, ultimately providing a fully validated NetSuite instance that is easier to manage on an ongoing basis.
Key Benefits
Improved collaboration
Enhanced compliance
Accelerated go-live time
Netwrix Products
Customer Profile
Oncopeptides is a Swedish biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers. More than 20 years after its founding, the company is still dedicated to providing patients with access to its innovative alkylating drug.
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