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Asking the Right Questions: How Does Process Intersect with Quality?
Key considerations and best practices for successful digital transformation in regulated industries
In life sciences, quality is a non-negotiable. From pharmaceutical manufacturing to medical devices, every product must meet strict regulatory standards to ensure safety and effectiveness. When implementing an ERP system, quality needs to be a top priority to ensure long-term success and compliance.
Quality Control at Every Stage
Too often, ERP implementations in life sciences overlook the importance of integrating quality at the core of the process. The biggest question to ask your team and partners is: "How do our processes intersect with quality?" This due diligence ensures that critical requirements, such as FDA compliance, validation, and audit readiness, are met. Involving quality experts from the start helps align every step of the implementation with the regulatory environment of life sciences.
Key Considerations for Compliance and Validation
ERP implementations should focus on more than just meeting financial and operational needs. In life sciences, it’s crucial to think through regulatory compliance, GAMP 5 standards, and independent verification and validation (IV&V) requirements. Continuous updates from cloud vendors, like Microsoft, mean that validation processes need to be ongoing, not just a one-time effort.
Ensuring FDA Audit Readiness
A major concern for any life sciences manufacturer is preparing for FDA audits. ERP systems must include controls for inventory batches, data security, and audit logs that comply with FDA regulations. By involving quality SMEs in every meeting, companies can ensure that their ERP system supports these critical compliance needs.
Quality in life sciences ERP implementation goes beyond just meeting operational goals—it’s about ensuring regulatory compliance and maintaining validation over time. With the right team and processes in place, your ERP system will support your business’s growth while adhering to industry best practices. Ready to integrate quality at every step? HSO can help you lead the way.