OVERVIEW
Audit Insights features a “Virtual Auditor” that evaluates project data for compliance with industry standards and quality best practices, including ISO 14971, IEC 62304, ISO 13485, and others.
This versatile tool allows users to define regulations directly within the tool or through a simple Excel or Google Sheet. Users can specify the standard, section, classification (in the case of medical devices – Class I, II, III), remediation requirements, and various other parameters. Subsequently, these defined regulations can be imported into the Orcanos ALM and QMS platform, establishing a connection with electronic records.
It conducts scans of project data in accordance with the specified regulations and associated logic. It presents identified issues in an executive summary format. When combined with Orcanos’ dashboard and notification mechanism, this integrated approach provides enhanced control and monitoring capabilities.
Audit Insights BASICS
Audit Insights comprises a collection of electronic records known as Compliance Audit (Code=CCA), and these records are exclusively managed within the ALM Templates project.
You can access the Audit Insights from the sidebar.
To enable the Compliance and Governance option:
- Go to Admin->Data Sharing and Settings->Modules
- Check the Audit Insights option for the relevant groups (default=”All”)
SETUP COMPLIANCE CHECKS
The mechanism of the Audit Insights is straightforward. You need to define Compliance Audit work items (We will refer to them as CCA) for every compliance rule you wish to setup (such as “Requirements shall have test traceability”)
Then, build a filter (such as “ISO 14971 Audit“) to be applied ONLY to the CCA work item within the ALM Templates project.
To set up compliance Audit work item:
- Select the Design Control from the sidebar.
- Select the ALM Templates project from the Project Selector drop-down list at the top of the left pane and click the List View icon.
- Select the Compliance Audit work item on the left pane.
- Click the + (Add) button to add the Compliance Audit item.
Let’s review CCA work time properties:
- Key – unique identifier, system-generated
- Name – the short description of the Compliance audit check. Example: “Software requirements must have test traceability“
- Compliance Remediation – describe what is required to resolve this CCA, in case it fails.
- Compliance Class -Select the Safety Class (I, II, III)
- Compliance Standard – list of standards (Such as IEC 62304, ISO 13485, ISO 14971…)
- Work Item – If this CCA is required to check a specific work item – select the relevant work item from this list (such as “Software Requirement“)
- Compliance Enumerator – internal numbering, must be unique
- Compliance Logic – this is the heart of the engine. Here you select the Logic to apply when running the Compliance engine check. This list is constantly updated. The available values are as follows:
- SP_COMPLIANCE_DEFECT_STATUS_CHECK – Examines the number of active (Fail) or complete (Pass) statuses of Defect items.
- SP_COMPLIANCE_FAIL_TEST_CHECK – Evaluates the Pass (Pass) or Fail (Fail) status of test cases in the selected project.
- SP_COMPLIANCE_STATUS_CHECK – Assesses the number of active (Fail) or complete (Pass) statuses of the selected work item.
- SP_COMPLIANCE_TEST_TRACE – Chooses the quantity of records for the selected work item with test traceability (Pass) and without traceability (Fail).
- SP_COMPLIANCE_TRACE_APPROVED_CHECK – Determines the number of records for the selected work item with traceability to COMPLETED STATUS work items (Pass) and without traceability (Fail).
- SP_COMPLIANCE_TRACE_CHECK – Identifies the number of records for the selected work item with traceability (Pass) and without traceability (Fail).
- SP_COMPLIANCE_TRACE_PASS_TEST_CHECK – Selects the number of records for the selected work item with test traceability and a Pass status (Pass) and without traceability or with a Fail status (Fail).
- SP_COMPLIANCE_UNACCEPTED_RISK – Reviews the number of risks within the acceptable zone after mitigation (Pass) and those outside the acceptable zone (Fail).
- SP_COMPLIANCE_FILTER_BASE – This is a powerful mechanism for creating a compliance rule based on a filter. Two available files include:
- Compliance Audit Total: Shows the total items audited (e.g., All software requirements).
- Compliance Audit Inconsistency: Displays the total items that failed in a specific rule (e.g., all software requirements without test cases).
Note: For traceability auditing, you need to link item in the audited project to the CCA in order for this audit to Pass
- Status – Status of the CCA
- Compliance Module – Module classification, such as CAPA, Requirements Management, Test Management, Risk Control and more
- Compliance Regulatory Authority – Such as CE, FDA
- Compliance Criticality – This is a system field to be used to indicate how critical this CCA is (High Medium Low)
- Compliance Type:
- Standard Checklist: Derived directly from the official standard.
- Best Practice: Although not explicitly outlined in the standard’s sections, it fulfills a specific requirement. For instance, ensuring that defect statuses are completed may not be mandated by the IEC 62304 standard, but it is considered a best practice in the Orcanos system to ensure thorough defect verification.
- Compliance Section – the section in the standard (Text)
CREATE COMPLIANCE FILTERS
You can now generate multiple filters for auditing safety, design, all, quality, and more.
These filters will categorize a list of CCA items to be utilized in the audit.
The fields you choose in the filter will be displayed on the executed audit report.
For additional details on filters – click here
Note: You must include Priority, Compliance Logic and Remediation in the filter
RUN Assessment
To run an assement:
- Select the Audit Insights module from the sidebar.
- On the top-right side, click Run Assessment.
- Select the Project you wish to check.
- Select the Compliance Filter you wish to apply.
- Click the Run Button.
You will get the results as follows:
Expand each audit (CCA) using the button on the right.
The Pass or Fail status is indicated by Green for Pass and Red for Fail. If a group of e-records is audited and one fails, the check will be marked as failed.
Details included in each audit (CCA):
- Name of CCA
- Number of items audited
- Number of items failed in the audit
- List of selected filter fields (values only)
- Description of CCA
- Remediation steps for CCA
- Related items, if any, are displayed here
- Criticality (High, Medium, Low) is shown on the right side of each CCA.
RELATED LINKS
Compliance Custom Fields