The Problem: When Isolated Data Needs to be Brought into Compliance Manufacturing equipment produces huge amounts of data each day. In many cases, for newer equipment, data collection is built into...
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Members of the manufacturing and quality departments know that properly managing all of the documents associated with the batch record is essential. Once a facility has put in the necessary...
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Those who have been tasked with documentation lifecycle management for highly regulated industries know what a daunting task it can be. Adhering to Good Manufacturing Practices (GMP), such as meticulous...
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Curious about our new InfoBatch® InfoETL solution but unsure what "ETL" actually means? We've written a brief guide on ETL so you can better understand how InfoETL can help you...
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Both American and European regulatory bodies publish guidelines for Good Manufacturing Practices that detail proper protocol for pharmaceutical manufacturing. According to FDA CFR 21 Part 211, “Batch production and control...
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Logbooks are utilized extensively throughout manufacturing operations to capture records of operator activity and critical process data. These records ensure that activities are completed in a safe and timely manner and...
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