The U.S. Federal ESIGN Act defines an electronic signature as an “electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.” Well, what does that mean?
In the Pharma and Life Sciences industries, Part 11 of Title 21 of the Code of Federal Regulations (21 CFR 11) addresses electronic signatures. Part 11 allows two-part authentication, such as username and password. Checking the box of an assertion that "I have read and understood this material" will also work. Along with the E-Signature, the SOP training content itself, and any post acknowledgement test results must be archived to ensure an auditable record of who read and acknowledged what. Compliant E-Signature handling demands a comprehensive SOP training management solution.
The ShareKnowledge Learning Management Solution (LMS) offers a complete solution for SOP training. Training managers start by publishing their regulated content to a course catalog and specifying that E-Signatures are required. Next, they select which type of E-Signature (two-part authentication or check box) is required. ShareKnowledge automatically restricts changes to the training material once it is connected to an E-Signature requirement.
What happens when there is more to do than read and acknowledge the SOP? When regulated training requirements extend beyond simply reading and acknowledging regulated content, a training manager can add “Face to Face” trainings, reading activities, e-learning courses, and quizzes to the SOP, depending on the individual training requirement.
How does the training manager distribute the SOP training? There are two ways to do this. The training manager can create a distribution list of employees and other stakeholders who must acknowledge the SOP, or build a set of rules that specify which organization regions, departments, and roles will be receiving the SOP content. Either way, SOP material reaches the right trainees, and ShareKnowledge manages the distribution, E-Signature capture, and makes it all available to managers and observers with a specially designed suite of reports.
How does the trainee receive the SOP training? Once the training manager has completed the distribution plan, an employee or other trainee will see the SOP appear in their individual ShareKnowledge Learning Plan. Whether the training simply requires an E-Signature or additional activities like having a meeting or taking a quiz, the whole story is there in the training plan.
If you have training requirements that require E-Signature handling, ShareKnowledge LMS has you covered. Comprehensive SOP training workflows, distribution lists and rule based distribution, and trainee learning plans deliver regulated content to the right people, at the right time, with the right capture and reporting. ShareKnowledge LMS means regulated content peace of mind for you.