Electronic batch record (EBR) systems can replace paper batch process records with complete, paperless, electronic batch recording with electronic signature.
EBR allows pharmaceutical and other regulated industries to enjoy the full advantage of simplified electronic record keeping and electronic signature. It complies with FDA 21 CFR part 11, which became effective in August 1997. The final rule provided criteria under which the FDA would consider electronic records to be equivalent to paper records, and electronic signatures equivalent to hand-written signatures.
"Our electronic batch record system provides FDA regulated industries with the means to realise the productivity benefits of paperless manufacturing," said David Tatich, Product Manager. "These benefits include improved record keeping and increased quality and comprehensiveness of security, data integrity and audit trails."
EBR guides the operator through the various sequential steps involved in the manufacturing process. It has a built-in user validation system to limit usage to authorised personnel for data entry as well as recording of batch events and reports. This provides greater consistency from batch to batch as well as improved batch integrity. It also reduces the amount of time spent on obtaining batch record approvals. With full support for wireless devices, including handheld bar code readers, EBR makes essential documentation available at any location in the plant. The use of handheld bar code readers for data entry and system validation of entries eliminates transcription errors and improves the efficiency of the manufacturing process. Because the process is portable, the user can bring it to the people needed for additional signature approval, regardless of where they are in the plant.
ABB is a major worldwide automation supplier; the company's automation business segment includes major product areas such as control products and systems, manufacturing execution systems, instrumentation, analytical devices, meters, robotics, drives, motors and machines. Major industry markets served are chemicals, pharmaceuticals, oil and gas, food and beverage, pulp and paper, metals and minerals, manufacturing industries, marine, and utilities.
ABB (www.abb.com) is a global technology company that serves customers in power transmission and distribution; automation; oil, gas, and petrochemicals; building technologies; and in financial services.
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