| OVERVIEW |
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| Xyntek has helped a number of pharmaceutical companies in their transition to paperless manufacturing environments. Part of the move to comply with FDA’s 21 CFR Part 11 involves the use of electronic batch records, or EBR (files maintained on a computerized system that contain batch-related data). Having hands-on experience with validation and compliance, and understanding the conditions under which an EBR can be considered an acceptable substitute for paper, has made Xyntek the ideal choice for implementing a compliant solution for recording batch-sensitive data. Xyntek uses its ITX-EBRS© System to achieve compliance and to simplify the process of capturing, recording and archiving this data. |
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| METHODOLOGY |
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| An in-depth knowledge of automated batch process control systems is critical for understanding the requirements for an EBR. Using this knowledge, Xyntek�?????�????�???�??�?�¢??s engineers developed the ITX-EBRS�??????�?????�????�???�??�?�© System to follow their standard methodology for the Project Management, Software Development Life Cycle (SDLC), and Part 11 compliance. The software architecture was built with OPC standards in mind, to allow for a flexible communication protocol that can be adapted to any type of controller or production line equipment. With additional features such as configurable security and reporting capabilities, the ITX-EBRS�??????�?????�????�???�??�?�© was developed to be a full-scale solution to all Batch Management, Batch Process Control, and 21 CFR Part 11 requirements. |
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| RELATED PRODUCTS |
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ITX-EBRS©: Electronic Batch Record System |
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