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welcome to this innovation solution video by micro focus if you are developing products or software in the biomedical industry you will be required to be compliant with FDA 21 CFR part 11 this is a section of the Code of Federal Regulations from the United States Food and Drug Administration's guidelines on using electronic records and electronic signatures organizations have regulated the apps need to ensure that any changes in access to those regulated apps have been conducted through a rigorous and auditable process and there are rules and important steps to be taken to ensure that electronic records and signatures are compliant under the regulations you may already be using microfocus application lifecycle management to manage your apps delivery it's a great platform to help you deliver your enterprise apps in either an agile hybrid or traditional setting it enables requirements backlog management sprint management testing running your CI pipelines and seeing everything through one prism with the many different dashboards it offers introducing a signature for microfocus ALM along with all the great features in LEM octane our signature solution is a way to tightly integrate with your apps delivery and keep you in compliance with FDA requirements a signature for alm octane capabilities include electronic signature an approval for regulated workplace applying signatures on workflow transitions on each individual app lifecycle entity we can use bulk changes by a bog approval tool and we customized a workflow and each signature requirement according to your specifications our solution works by using alm octane workflow rules and form configurations combined with native am octane user groups and our each signature added to enable you to configure what is signed and who can approve workflow and transitions let's now look at a quick demo we're now going to login to a limb octane and progresses a story through a workflow we'll select that user story and move the face to the next transition the solution uses a low marketing workflow and rules to limit access to modifying the record it provides an operational workflow and implements Authority checks and these are all requirements by the part eleven requirement for records in the FDA regulations to modify the workflow and transition the phase use the easy venture button to progress the workflow the e-signature tool will only display the allowed workflow phases we will select the next phase to move to and note that this part of the workflow does not actually require an air signature so when the record is updated there is no a signature recorded yet we will now transition to a phase that requires an authorized user to assign a record this is the part of the workflow that does require confirmation by a signature the confirmation screen conveys a message that is configurable by your organization that message in this case advises the approver that they are making a legally binding decision equivalent with providing a handwritten signature the authorized user must enter the user...