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JUL-AUG 2017

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Convert Your Mobile Device into a HART Communicator … with our Advanced HART-based Products Get Data...On the Go! C O N N E C T > C O N F I G U R E > D O C U M E N T DevComDroid Communicator App Full DD access to HART instruments using your Android device DevCom2000 Communicator Software Full DD access to HART instruments using your Windows device HART Modems (Interface Hardware) Bluetooth, USB and RS232 models cally so they can be easily retrieved later as records for regu- lators to prove product was made within specification. Standardization and simplification Standardizing before implementing a manufacturing execution system to understand data flows and workflows will give you a much higher probability of a successful implementation. Audit trails Audit trail information can reside on all types of disperse systems, and it can take time to pull together an analysis. You need to have the right subject-matter experts, which can include the system administrator, system owner, pro- cess owner, and technical expert, do a complete review. Then look for any kind of pattern that shows some type of abnormality, a trigger point that is a clue to dig deeper. Audit trails encompass a wide range of systems, including control systems, execution systems, operational systems, analytical systems, and instrumentation. Data is fundamental Data provides direct evidence that our products are safe and effective. Data tells the story of our medicines long after they have been shipped. Proper practices, systems, procedures, and training are important, because regulatory expecta- tions and focus on data have increased. Business process simplification and standardization is an important step. Technology complexity is increasing, making investment in INTECH JULY/AUGUST 2017 33 AUTOMATION IT • Identify the critical data and corresponding business process. • Review system architecture: Ensure metadata and audit trails are being backed up at the correct level (e.g., ITCP, DRP) and at the necessary frequency for record retention and review. • Active directory integration can really help. • System access: Review regularly, limit the number of administrators, ensure segregation of duties • Synchronize time (automatically or procedurally) for systems that capture records. • Review physical and logical access to system data. • Systems that can generate validated audit trail reports significantly help! Level 4 Enterprise Level 3 MES/ historians, etc. Level 2 Line controls Level 0/1 Plant and equipment Consistent system implementation with data governance (IT, automation, lab systems) As-is review To be Implementation Business process mapping regulatory perspectives Consolidation and standardization (e.g., standard workflows within eBR) training and people important to ensure the necessary skills exist to meet the regulators' requirements. Automation and IT systems configured, operated, and maintained "correct ly" can address many data integrity challenges. Automated au- dit trail reports as part of the standard application software is a real opportunity to help industry. n ABOUT THE AUTHOR Bill Lydon (blydon@isa.org) is chief editor of InTech. Lydon has been active in manufacturing automation for more than 25 years. He started his career as a designer of computer-based machine tool controls; in other positions, he applied program - mable logic controllers and process control technology. In ad dition to experience at various large companies, he cofound- ed and was president of a venture-capital-funded industrial au tomation software company. View the online version at www.isa.org/intech/20170805. RESOURCES ISA-18, Instrument Signals and Alarms www.isa.org/isa18

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