5.1 - Creating or Editing Audit Reports
Audit reports combine selected sensor records, alert information, annotations, statistics, charts, and compliance details into a configurable PDF report.
Users with the Audit Admin role can create and edit audit reports and configure automatic email schedules. Completed reports are made available to authorised users through Audit Reports in the Visualisation section of the platform sidebar.
Open Audit Maintenance in the administration area and select Add / Edit Audit Reports. The index page lists the audit reports created under the company account, with Edit and Delete actions available for each report.
Configure the Audit Report
Select Create Audit Report at the top of the index page, or select Edit beside an existing report. The same form is used for both actions and is organised into three main areas.
Enter the Report Details
Enter a unique Site Name and Report Name, then select the Time Zone used for dates and times in the report. The report time zone can differ from the host account time zone.
Choose the Information to Include
Select the charts, alert records, annotations, statistics, detailed data, raw-data extracts, audit events, and signature content required for the report. Each option is explained below.
Add Nodes and Sensor Inputs
Use Add Node to include each required node, select the sensor input, enter optional chart limits, and set the order in which the records appear.
Information to Include
Alert Configuration and Notifications
- Include Alert Setup: Lists the alerts configured for each included node.
- Include Email Alerts: Lists email notifications sent during the report period, including the time and recipient.
- Include SMS Alerts: Lists SMS notifications sent during the report period, including the time and recipient.
Charts and Device Statistics
- Include Charts: Adds a chart for each included sensor input, with the configured upper and lower limits.
- Include Device Statistics: Adds minimum, maximum, average, and standard-deviation values for the selected period.
Annotations and Audit Events
- Include Annotations: Lists annotations recorded against alert and recovery events. See Section 4.3 - Adding and Editing Annotations.
- Include Audit Events: Adds detailed audit-event information for compliance records. This can produce a large amount of data, so a separate audit report may be preferable.
Detailed Data in the PDF
Include Detailed Data adds the raw data for all selected nodes as a table at the end of the PDF. This can significantly increase the report size and is generally best used only when the detailed records are required.
CSV and Excel Extracts
- Include CSV Extract: Attaches a CSV file containing the raw data when the report is sent by a scheduled job.
- Include Excel Extract: Attaches an Excel file containing the raw data when the report is sent by a scheduled job.
These extracts are not included when a report is downloaded manually. Raw data can instead be exported from the Reports page.
Digital Signature Page
Include Signature Page adds digital-signature fields at the end of the PDF. See Section 5.4 - Digitally Signing an Audit Report for the signing process.
Audit events and electronic signatures can support records managed under FDA 21 CFR Part 11.
Nodes to Include
Select a node from Add Node, then configure each row. The same node can be added more than once when several sensor inputs from that node are required.
- Input: Selects the sensor input included in the report.
- Lower Limit: Adds a blue lower-limit line to the sensor chart.
- Upper Limit: Adds a red upper-limit line to the sensor chart.
- Sort Order: Controls the order in which nodes and sensor inputs appear.
- Delete: Removes the selected sensor input from the report configuration.
5.2 - Downloading Audit Reports
The Audit Reports page is available to users through the Visualisation section of the platform sidebar.
A report is visible only when the user has access to every node included in that report. Node access is managed through Section 6.2.3 - User Roles and Node Access Control . Users without the Audit Admin role can download available reports but cannot change their configurations.
- Select the required report from Report Name.
- Enter the required Start Date and End Date.
- Select Load.
The completed audit report is generated and downloaded in PDF format.
5.3 - Automatically Emailing Audit Reports
Users with the Audit Admin role can create scheduled jobs that generate and email audit reports automatically.
Create the Audit Report
Confirm that each report to be emailed has already been configured. See Section 5.1 - Creating or Editing Audit Reports.
Prepare an Email Notification Group
Create a notification group containing at least one user who can receive email. See Section 6.2.4 - Notification Groups . A dedicated group can keep audit-report recipients separate from operational alerts.
Create the Schedule
Open Audit Maintenance in the administration area and select Create Audit Report Schedule. Complete the following fields:
- Description / Email Subject: Enter the subject line used for the email.
- Email Notification Group: Select the group containing the report recipients.
- Item to Run: Select the audit report to generate.
- Run Frequency: Choose how often the job runs, such as daily, weekly, or monthly.
- Run On: Select the applicable day for the schedule.
- Run At Time: Set the time at which the report is generated and sent.
Select Enabled to activate the schedule, then select Create to save it.
5.4 - Digitally Signing an Audit Report
When an audit report includes a signature page, the downloaded PDF can be signed electronically without printing, signing, and scanning the document.
A digital signature securely associates a signer with a document and records the signing transaction. Public Key Infrastructure, or PKI, is the commonly accepted standard used for this type of electronic signature.
The signature page contains two fields:
Checked by
The person responsible for reviewing and validating the audit report.
Approved by
The person responsible for approving or verifying the completed report.
Apply the Digital Signature
- Download the audit report as described in Section 5.2 - Downloading Audit Reports.
- Save the PDF locally and open it in a desktop PDF application that supports digital signatures, such as Adobe Acrobat Reader. Most web-browser PDF viewers cannot apply a certificate-based signature.
- Select the appropriate signature field in the PDF.
- Choose an existing digital ID or create a new one when prompted.
- Apply and save the signature. A digitally signed document cannot then be modified without invalidating the signature.
Adobe Acrobat Reader can also request a signature from another person. For more information about digital IDs, refer to Adobe's digital ID guidance.
