Supporting Commercial Laboratories As business customer requirements often change, business laboratories must be flexible. Instead of analyzing a product or batch, a commercial laboratory usually analyzes exotic samples and needs to handle routine inspections and special analyses.
Routine inspections and analyses include analysis of product shelf life, testing of water quality or soil in accordance with relevant regulations, etc., all in accordance with the required time and testing objectives. SAP's quality management can be based on the test plan and pre-defined time analysis according to plan, automatically generate inspection orders. After balancing the inspection capability, the inspection order is issued to the laboratory or inspector before sampling and inspection preparation can be performed.
Commercial laboratories often receive unplanned testing and analysis tasks, such as testing specific pathogens, or analyzing sewage, soil, or air after failure. Through SAP Quality Management, the processor records the number of samples, flexibly selects inspection rules, such as the characteristics and test methods that need to be tested, and assigns them to each sample.
Sometimes the detection and analysis work must be carried out on site. The SAP solution supports mobile office equipment such as PDAs. The inspector can record the test results on the spot and send it directly to the quality management system through the mobile device. Test results can also be recorded via the Internet. In addition, you can use complex formulas to calculate test results, or transfer measurement data directly from connected test equipment to the system. After the quality inspection is completed, the analysis certificate can be issued according to customer requirements. Customers can download these certificates from the Internet, so that corporate customers can receive quality inspection certificates before receiving goods, reducing the customer's management costs.
The quality inspection process can also calculate the cost of each customer's inspection, charge according to different analysis results and inspection methods, and present it on the invoice.
Compliance with GxP Standards and US Federal Code Codes GxP is an acronym for Product Clinical (GCP)/Laboratory (GLP)/Production Regulations (GMP) and is a regulatory requirement for specific industries such as pharmaceuticals, food, and beverages. For example, the US Food and Drug Administration (FDA) requires pharmaceutical companies with products entering the US market to provide a detailed, comprehensive and traceable production process management, including all processes that may affect product quality during the production process and the distribution of products. operating. At the same time, in the United States Code of Federal Regulations (CFR), the specification of computer systems responsible for electronic records is described in detail.
In analytical laboratories, it is very important to comply with the GxP data acquisition and validation process rules, which include data accuracy and consistency of document changes.
SAP's quality management can meet GxP's requirements, provide complete audit trails, support digital signatures of results records, and sample and product release. It also provides change management, electronic batch logging, and integrated document management capabilities to store related documents.
In addition, SAP's quality management eliminates interfaces between systems, optimizes data flow, and improves data accuracy and consistency to comply with regulations.
Open Interfaces SAP's quality management provides two standard open interfaces:
â— Inspection data interface (QM-IDI): used to connect external systems and subsystems â— Statistical data interface (QM-STI): used to connect with statistical programs QM-IDI interface connects quality management solutions with measurement equipment. The interface can also be connected to third-party special systems such as laboratory automation systems, chromatographic analysis systems, DNA sequencers or other applications.
Advantages of SAP Quality Management Through SAP's integrated quality management capabilities, companies can handle traditional lab lIMS functions and integrate the entire quality management. The advantages of using SAP's quality management system as an enterprise LIMS are:
â— Obtain a flexible and scalable system, and have an open architecture to meet future needs â— Effectively reduce costs and accelerate processes, achieve standardized management throughout the company â— Collaborate with internal and external partners throughout the product life cycle â— Integrate with other application software to minimize the complexity of the system and ultimately reduce costs SAP's quality management function introduces a comprehensive approach, a complete, fully integrated LIMS solution with a relatively low overall cost. At the same time, the program also establishes a flexible foundation for the company to obtain a method for achieving LIMS and quality management across the entire enterprise. SAP is the world's leading provider of enterprise management software and collaborative commerce solutions. More than 80% of Fortune 500 companies use SAP's business solutions.
Routine inspections and analyses include analysis of product shelf life, testing of water quality or soil in accordance with relevant regulations, etc., all in accordance with the required time and testing objectives. SAP's quality management can be based on the test plan and pre-defined time analysis according to plan, automatically generate inspection orders. After balancing the inspection capability, the inspection order is issued to the laboratory or inspector before sampling and inspection preparation can be performed.
Commercial laboratories often receive unplanned testing and analysis tasks, such as testing specific pathogens, or analyzing sewage, soil, or air after failure. Through SAP Quality Management, the processor records the number of samples, flexibly selects inspection rules, such as the characteristics and test methods that need to be tested, and assigns them to each sample.
Sometimes the detection and analysis work must be carried out on site. The SAP solution supports mobile office equipment such as PDAs. The inspector can record the test results on the spot and send it directly to the quality management system through the mobile device. Test results can also be recorded via the Internet. In addition, you can use complex formulas to calculate test results, or transfer measurement data directly from connected test equipment to the system. After the quality inspection is completed, the analysis certificate can be issued according to customer requirements. Customers can download these certificates from the Internet, so that corporate customers can receive quality inspection certificates before receiving goods, reducing the customer's management costs.
The quality inspection process can also calculate the cost of each customer's inspection, charge according to different analysis results and inspection methods, and present it on the invoice.
Compliance with GxP Standards and US Federal Code Codes GxP is an acronym for Product Clinical (GCP)/Laboratory (GLP)/Production Regulations (GMP) and is a regulatory requirement for specific industries such as pharmaceuticals, food, and beverages. For example, the US Food and Drug Administration (FDA) requires pharmaceutical companies with products entering the US market to provide a detailed, comprehensive and traceable production process management, including all processes that may affect product quality during the production process and the distribution of products. operating. At the same time, in the United States Code of Federal Regulations (CFR), the specification of computer systems responsible for electronic records is described in detail.
In analytical laboratories, it is very important to comply with the GxP data acquisition and validation process rules, which include data accuracy and consistency of document changes.
SAP's quality management can meet GxP's requirements, provide complete audit trails, support digital signatures of results records, and sample and product release. It also provides change management, electronic batch logging, and integrated document management capabilities to store related documents.
In addition, SAP's quality management eliminates interfaces between systems, optimizes data flow, and improves data accuracy and consistency to comply with regulations.
Open Interfaces SAP's quality management provides two standard open interfaces:
â— Inspection data interface (QM-IDI): used to connect external systems and subsystems â— Statistical data interface (QM-STI): used to connect with statistical programs QM-IDI interface connects quality management solutions with measurement equipment. The interface can also be connected to third-party special systems such as laboratory automation systems, chromatographic analysis systems, DNA sequencers or other applications.
Advantages of SAP Quality Management Through SAP's integrated quality management capabilities, companies can handle traditional lab lIMS functions and integrate the entire quality management. The advantages of using SAP's quality management system as an enterprise LIMS are:
â— Obtain a flexible and scalable system, and have an open architecture to meet future needs â— Effectively reduce costs and accelerate processes, achieve standardized management throughout the company â— Collaborate with internal and external partners throughout the product life cycle â— Integrate with other application software to minimize the complexity of the system and ultimately reduce costs SAP's quality management function introduces a comprehensive approach, a complete, fully integrated LIMS solution with a relatively low overall cost. At the same time, the program also establishes a flexible foundation for the company to obtain a method for achieving LIMS and quality management across the entire enterprise. SAP is the world's leading provider of enterprise management software and collaborative commerce solutions. More than 80% of Fortune 500 companies use SAP's business solutions.
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