The FlowForma Life Sciences Pack extends the FlowForma BPM Tool for Office 365 with additional functionality to enable advanced auditing, often required by the Life Sciences sector.
These Life Sciences features, when combined with FlowForma's Forms and Workflow, enables organizations within the Life Sciences arena to design and build processes that can be fully certified to meet regulatory requirements on electronic records for e.g. ISO 9001 and 21 CFR Part 11.
This feature pack works to enhance the audit abilities of the FlowForma BPM tool, capturing additional data and providing audit histories that are easily examined by auditors.
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Enables users to construct an environment that can be independently audited against regulatory requirements
Processes can be designed so that process steps and signed, historical form activity is clearly visible, and a snapshot of the workflow captured at a specific point in time
All records can be easily and quickly understood by external auditors, who may not have any prior knowledge of processes in use
The Life Sciences pack comprises of features that cover three specific areas; e-Signatures, an integrated form audit record and a flow snapshot (a document describing the flow definition). Together, these features provide all of the functionality required to validate FlowForma processes to 21 CFR Part 11 compliance. The same features can be used for compliance in many other industries, where regulatory compliance is required on the storage of electronic records.
The Life Sciences pack enables e-Signatures on step submissions. The default signature is designed for 21 CFR Part 11 compliance and prompts for role of signatory and purpose for signing as well as the password of the current user.
Alternatively, where Code of Federal Regulation (CRF) compliance is not required, a standard e-Signature is an option which simply requests a password.
Integrated Form Audit Record
The integrated form audit feature captures all actions that happen on a form throughout the process and also stores the audit record within the form. An audit viewer provides a human readable view of the audit record.
The Flow Snapshot allows the user to generate a document describing the content of the Flow Definition (the process template). The snapshot lists out every process step, question and business rule in the Flow.
The feature is aimed at compliance requirements where auditors require a human readable description of the Flow at a set point in time. This is a requirement for 21 CFR Part 11 compliance, but again is useful across many industries.