In today’s dynamic business environment, commercial laboratories face constantly evolving customer demands. As a result, they must remain highly adaptable. Rather than focusing solely on analyzing standard products or batches, these labs often handle complex and unconventional samples, while also managing routine inspections and specialized analyses. This requires a flexible and efficient approach to quality management.
Routine inspections and analyses may include assessing product shelf life, conducting water or soil quality tests in compliance with regulatory standards, and more—all according to specific timeframes and testing objectives. SAP Quality Management enables labs to create test plans based on predefined schedules, automatically generating inspection orders. Once the lab's capacity is balanced, the orders are issued to the appropriate team before sampling and testing can begin, ensuring smooth workflow and timely execution.
In addition to scheduled tasks, commercial labs frequently encounter unplanned requests, such as testing for specific pathogens or analyzing environmental samples like sewage, soil, or air after an incident. With SAP Quality Management, processors can record sample counts, select flexible inspection rules based on required characteristics and methods, and assign them to individual samples, streamlining the process.
For fieldwork, SAP supports mobile devices such as PDAs, allowing inspectors to record results on-site and transmit them directly to the quality management system. Results can also be entered via the internet, and the system supports complex calculations or direct data transfer from connected instruments. After completion, certificates can be generated per customer requirements and made available online, enabling clients to access them before receiving goods, thus reducing their administrative burden.
The system also tracks the cost of each inspection, allowing for accurate billing based on different analysis methods and results, with clear presentation on invoices.
Compliance with GxP standards (Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice) and U.S. Federal Code regulations is critical in regulated industries such as pharmaceuticals, food, and beverages. For instance, the FDA mandates detailed, traceable production processes for products entering the U.S. market, including all steps that could affect product quality. The U.S. Code of Federal Regulations also outlines strict requirements for electronic records and data integrity.
In analytical labs, adhering to GxP data collection and validation procedures is essential, ensuring data accuracy and consistent documentation. SAP Quality Management meets these requirements by offering full audit trails, digital signatures for records, and support for sample and product release. It also includes change management, electronic batch records, and integrated document management to ensure proper storage and accessibility of related files.
Moreover, SAP enhances regulatory compliance by eliminating system interfaces, optimizing data flow, and improving data accuracy and consistency across the organization.
SAP provides two standard open interfaces: the Inspection Data Interface (QM-IDI), which connects quality management systems with measurement equipment and third-party applications like lab automation or chromatography systems, and the Statistical Data Interface (QM-STI), which links with statistical software. These interfaces allow seamless integration and data exchange.
Using SAP Quality Management offers numerous advantages, including a scalable and flexible system with an open architecture that supports future growth. It helps reduce costs, streamline operations, and achieve standardized management across the enterprise. It also facilitates collaboration with internal and external partners throughout the product lifecycle and integrates smoothly with other enterprise applications, minimizing complexity and overall costs.
SAP’s comprehensive solution delivers a fully integrated LIMS (Laboratory Information Management System) at a lower total cost. It provides a flexible foundation for enterprises to implement LIMS and quality management across their entire operations. As a global leader in enterprise software and collaborative commerce solutions, SAP serves over 80% of Fortune 500 companies, making it a trusted choice for organizations seeking reliable and innovative quality management systems.
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