By David Raths
Managing training and regulatory compliance in the life sciences field is extraordinarily complex. Among other things, it requires creating educational material covering hundreds of standard operating procedures (SOPs) both in manufacturing and sales and marketing, validating that the training has been attended and creating an audit trail that regulators such as the U.S. Food and Drug Administration can follow. Larger companies have the additional complexity of operating in a multinational environment.
Today, pharmaceutical companies can turn to an array of cloud-based learning management systems that ensure government compliance for electronic signatures and record-keeping, including compliance with a regulation called Title 21 CFR Part 11, which specifies how validation is handled to make sure inputs are not manipulated and audit trails are available.
Read more at KMWorld