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The Quality Assurance Audit System (QAAS) is a MS Office Add-In that provides a formal environment through which Users can:
- Generate Audits
- Input audit findings
- Track and trend audits and findings
- Electronically address audit findings and provide responses, resolutions and CAPAs.
- Generare ad-hoc metrics and scorecards with built-in search engine
- Progress audits from Draft to Approval with a full workflow, electronic signatures and email notifications.
The following screen captures provide a walkthrough of a typical scenario involving the generation of an Audit File, logging of comments, responding to comments and close-out/approval. To view a short video demonstration, click here.
From the Main Menu, users can perform various actions such as creating an audit, looking up an existing audit, using the search engine or viewing metrics.
Initiating a new Audit is simple, intuitive and is accomplished in minutes. Each new audit is automatically given a unique sequential number and user simply:
- Selects an audit type from a prepopulated listing, for example “Intraperitoneal Dosing”
- Enters a finding in the provided text entry field.
- Selects a “finding type” to categorize the comment from a prepopulated listing, for example “Protocol Deviation”.
- Selects a severity level for the finding from a prepopulated listing, for example “Moderate”.
- Saves their audit finding by clicking on the “Update Repository” button.
Once a finding is entered and saved, the system asks the user if more findings are needed for this audit. Audits do not have to be completed in one session.
In this example, the user has added an additional finding for the audit. As findings are entered, they are readily seen in the “Comments On File” pane on the right.
To address an audit finding, each responsible stake holder can log in to QAAS, select the audit number and provide their response to the finding.
Once all findings have been satisfactorily addressed, an auditor can log in and approve/close the audit file by providing an electronic authentication.
At any time throughout this process, quick reports and metrics can be called from the main menu in 1 mouse click! In this example, a user has generated a text report to show all CLOSED AUDITS:
Turnkey pricing is $4999.00 per site/facility with access for multiple users.
For more information on Quality Assurance Audit System (QAAS), click here.
To request more information, ask a question or to schedule a demonstration of QAAS, click here.
To purchase a turnkey build of Quality Assurance Audit System (QAAS), click here.