Create, assign, and track employee training with Oracle Fusion Cloud
Medical devices manufacturers and FDA regulated businesses face the challenge of tracking training requirements with continuously changing product documents and processes. Regulatory authorities require these organizations prove that training is tracked, audited, and continuously meets all regulatory guidelines. One such regulatory rule is 21 CFR Part 11, which governs the use of electronic records and signatures and applies to companies in the life sciences industry, including medical device manufacturers, pharmaceuticals, biotechnology, and OTC products. Because PLM systems control all the documents and processes that users need to be trained on, the PLM application itself is best suited for tracking all training requirements and proving that training is sufficient and completed in a timely manner.
The Inspirage Electronic Training Record (ETR) Solution is seamlessly integrated into Oracle PLM Cloud and serves as a tool for managing, facilitating, and reporting on employee training. This solution creates automatic training sessions by job functions based upon specific configured requirements during Change Order releases, enabling businesses to save time and ensure compliance. Inspirage’s ETR solution ensures companies remain up to date on their accreditation. To enable oversight and management of training processes, the solution produces reports and audit information for training progress that can be utilized by organizations to prove compliance to auditors. Since the ETR solution is merged with Oracle Fusion Cloud, there is no need to login to another system. All training and reporting can be done within the same system.
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