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QuTrack QMS - Audit Management

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Audit Process Scenario

Customers & Regulatory Bodies ensure the capability of the company in delivering Quality with Compliance through external audits and internal audits. So certainly companies especially those with a global supply chain spend an exhaustive amount of time with huge investments in Audit Management, right from audit planning to sending audit response report. Because of its complexity, countless man-hours and high stakes involved, the need for an automated Audit Management Software for Life Sciences companies exists naturally.

Audit Management Software Solution

This Audit Management Software enables the Organization to manage internal audits and external audits by automating and streamlining the Audit Management process, addressing the current paper-based challenges in managing audits to their core. The Audit Management System allows audit scheduling, audit planning, audit completion and creation of findings, follow-up of findings through investigations, audit closure with findings closure and response report submission to Customer/ Regulatory.

By adopting industry best practices into our audit software workflows the Audit Management solution ensures appropriate reviews, comments and approvals besides maintaining effective communications across the involved departments through notifications and automated alerts. With flexibility in configuring workflows it is easy for the Audit Management software to be re-defined into your current Audit Management process within in a short period.

The Audit Management Software is made capable to integrate with other quality systems of Quality Management for a seamless workflow, traceability and transparency across the organization. For example all associated CAPAs are managed and closed at the CAPA Management System.

In-depth Audit analysis and Audit tracking are made available with the click of a button with Summary Reports and Metrics Reports. Summary Report gives real-time visibility of the current audit record and metrics reports brings performance visibility of the Audit Closures across the organization on any given date.

Besides providing best approach for effective management of audits , the solution is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing audit trails, e-signatures, controlled printing, controlled access, records management and archival in accordance to regulatory standards and policies of an Organization.

VeServ Audit Management Advantage

This Audit Management Software System went through an extensive research on Audit Guidelines in developing software to effectively manage audits and close them efficiently with these core benefits..

  • Web based approach allows Audit Management Software accessibility from anywhere within the Site or Organization
  • Manage all types of internal and external audits
  • Total compliance with 21 CFR part 11
  • Integration and linkage to other Quality Systems that ensures seamless traceability under one solution – Quality Management System
  • Customizable and configurable within short period to re-define this audit software into your current audit management process
  • Customizable Reports according to the Audit Response Report Templates
  • Easy to define fields that capture audit and related information extensively and in-depth
  • Supports follow-up of findings originated from Vendor Audit and tracks them through vendor responses

Apart from being an industry standard and effective audit management software solution, the system has several key features that are practical and problem oriented.

Key Features

Simplified Audit Scheduling & Planning

Any type of audit can be scheduled at Annual Calendar that allows information to be captured in detail. By providing the functionality to review, comment and publish confirmed schedules to involved departments, the upcoming audit is planned and scheduled. Besides the Annual Calendar allows scheduling of audits for an entire annual year and then manage month-wise.

Automated Audit Report Creation

The system has capabilities to automatically create a blank audit response report immediately after completion of the audit. The report is not only auto generated but the information within the audit schedule is moved into the report reducing repetition. Besides the audit schedule and audit response report are linked to each other to have a seamless switch between them.

Direct Auditor Entry

An auditor with required permission can directly enter the findings into the system and avoid the duplication of re-entering findings into the system from hard-copy.

Auto Spell

Entered information needs to be described in detail and spelled correctly. The in-built spell check feature ensures all audit related information entered into the system is spelled correctly. By auto suggesting and auto correcting with good user interface, users can quickly complete data entry which helps in avoiding repetitions and reduces time spent.

Automated Alerts & Notifications

This is practical feature that ensures that the users are automatically communicated at defined frequencies and defined workflow steps about the approaching due date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue to the concerned authority to bring immediate response.

Audit Trails & E-signatures

The trail of the record is tracked and time-stamped providing details of actions performed, at the workflow steps giving in-depth traceability about who performed the action and at what time. Also the system features capturing of the user-consent to the action performed by entering a highly secured and high-level password i.e. e-signature.

Real-time Reports

Audit Summary Reports that provide real-time summary without opening the record helps personnel holding critical positions to save time by viewing the entire information in one go. Generation of reports on the status of the records enables high visibility of the Audit System and Audits. With eye catching graphical representation the audit reports are not only informative but impressive too.

Integrated Quality Systems

The Audit Management Software is designed to be flexible in integrating with other quality systems and establish a seamless and controlled workflow between audit management system and rest of the quality systems specially CAPA Management. The CAPAs originating can be initiated and closed at the CAPA Management with enabled status tracking at the Audit Management.

You can feel free to reach us to know more about this Audit Management System; software demo; software free trial and get your questions answered.

Industries that can benefit from our Solution

  • Pharmaceuticals
  • Biotechnology
  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages