Unlocking eSignature Lawfulness for Life Sciences in the United States

How to eSign a document: e-signature lawfulness for Life Sciences in United States

married for life science operations advances Dynamics 365 functionality to Support Compliance with FDA 21 CFR part 11 and meet the unique needs of life science organizations when it comes to eSignatures and electronic records any organization that sells services or products within the US must be in compliance with the 21 CFR part 11 electronic signatures and electronic records regulation this includes systems used by pharmaceutical manufacturers biotech or medical device organizations in the research production and distribution of products such as medical devices Pharmaceuticals blood tissue vaccines and other Biologicals the standard electronic signature capabilities in d365 cover many use cases but a couple of key life science requirements are missing the biggest one is the ability to apply multiple electronic signatures to a single record married for life science operations enables you to collect as many electronic signatures as you require for any individual record simply by submitting it to the workflow approval process identifying the reason code to the signature is a must from a compliance standpoint a signature comment provides an additional validation check additionally a unique electronic signature password must be provided when signing the record having the required auto trails behind critical processes is a must to stay compliant in order to support the client's audit and validation requirements common to the life science Industry we have developed the audit logic feature which allows clients to easily configure the audit trail reports for the data sets and tables that are essential for their business the beauty of the audit logic functionality is its flexibility to be configured on any table or data set here we see the approved vendor list audit report which shows who has run the report for which company legal entity with a timestamp next we can see who has added details to the record such as vendor expiration from and two dates with the timestamp then we can see who has submitted the record to the workflow resulting in the change in the workflow state to the submitted status we can see that the admin system has changed the status automatically from the submitted status to the pending approval status finally in the last step we can see who has approved the vendor using the electronic signature functionality with the reason code Associated comment resulting in approved vendor for the item [Music] with married for life science operations you'll benefit from the complete functionality you need to meet the unique requirements of your life science organizations in addition to standard Dynamics 365 capabilities marriage for life science operations helps you drive efficiency in your operations while ensuring your organization stays compliant contact us to learn more