Audit Management

Audit Management Software

Whenever the word Audit comes into the picture, there are many thoughts evolve in the quality professionals. For all the professionals in an organization, audit management software is one of the most critical, central, challenging and time-consuming parts of their role as well as challenging Regulatory will make or break the manufacturing companies as the company’s future lies on the performance.

AmpleLogic Audit Management software and Scheduling Software
enable the organizations to manage the schedules, solutions, internal & external audits by automating and streamlining the audit management process, addressing the current paper-based challenges.

Audits can be either:

  • Internal
  • Vendor/External
  • Regulatory Audit

They are conducted in three stages

  • Pre-Audit activities – Audit Planning.
  • On-Site Activities – Audit Execution.
  • Post Audit Activities – Reporting, Corrective Action, Follow up and Audit Closure.

Main Objectives of Pharmaceutical

  • Pharmaceutical manufacturers commonly use an effective mechanism to verify compliance with GMP (Good Manufacturing Practice) regulations.
  • GMP audits important goals:
    1. These are intended to verify control systems and Manufacturing is operating under a state of control
    2. Audits can help in correction of potential problems on prompt.
    3. Audits can help to establish a high degree of confidence

Challenges in Audit Management Software Systems:

  • Regulatory Audit Flexibility: Most of the pharma companies have many branches all over the globe with a large number of employees, this makes it very difficult to conduct an audit.
  • Audit Comparison: Risk assessment is done based on the area of operation and it differs from place to place which makes the manual process complicated.
  • Audit Evidence for reference: Evidence in the form of the written document always have a danger of getting damaged or lost.
  • Audit Findings as reference: Sometimes the data findings is one place that can be referred to the other places, in these scenarios company need to send hard copies of the data findings through the mail.
  • Eliminate Spread Sheets: Traditionally, audit management systems are comprised of a combination of spreadsheets and other manual processes. The manual steps required for these systems add to an already limited time period open to quality management professionals.
  • Audit Planning: In the planning stage, manual steps means- a number of time-consuming tasks including planning the audit calendar, writing the appropriate scope item documentation, notifying people of their individual actions, finding and printing any checklists.
  • Audit Scheduling: Planning and scheduling are complex, according to professionals, it is one of the biggest challenges.
  • Audit Planning Calendar: Another challenge is that the annual audit calendar can have small variations year on year. Annual audits are scheduled but there may arise unplanned. Managing the resources to make sure everything gets done can be a major obstacle for quality managers, particularly when it requires input and commitment from other people coordinating with others time management, ensuring and properly trained.

Features of AmpleLogic Audit Management Software

  • Simplified Audit Scheduling and Planning:
    Any type of audit can be scheduled at Audit Annual Calendar that allows information to be captured in detail, by providing the functionality to review, comment and publish confirmed schedules to involved departments. This helps to perform regulatorily and it reduces the effort of the team.
  • One of the unique features of AmpleLogic Audit Management Software and tracking system is that if there is a Surprise Internal Audit, the details can be entered after it is done.
  • There is a separate flow for each individual, whether it might be an internal, vendor or regulatory.
  • When internal audits are conducted, there is a provision to capture the details to find that will be a reference for the same level auditors.
  • Automated Audit Report Creation:
    The system has capabilities to automatically create a blank response. The report is immediately complete the audit and it’s not only auto-generated but also information is scheduled to move into reducing repetition. Besides the audit schedule and audit response, reports are linked to each other to have a seamless switch between them.
  • Direct Auditor Entry:
    An auditor with permission can directly enter the findings into the system and avoid the duplication of re-entering findings into the system from hard-copy.
  • Automated Alerts and Notifications:
    This practical feature 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 an immediate response.
  • Integrated Quality Systems with other Pharma Process Areas:
    The Audit Management Software is designed to be flexible in integrating with other quality systems and establish a seamless and controlled workflow between the audit management system and the 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 system.

Critical Advantages of Audit Management System

  • Connections between multiple systems will help quality managers to maintain an effective audit management software. As audit findings will likely lead to corrective and preventive actions and a number of follow up tasks, it would be extremely valuable to the quality professional to view and analyze non-conformances and track findings at the touch of a button. Without an automated system, it can be difficult to generate the subsequent audit report and review trends because this information is almost impenetrable without an excessive amount of time and effort.
  • AmpleLogic Audit Management Software provides a central focal point which integrates the entire audit lifecycle, allowing to plan, schedule, prepare, report and track audit actions through to closure – all from one electronic system.
  • Automatic generation of Audit templates from the system which are compliant with the standards of FDA, 21 CFR part 11, EU annexure 11 and other regulatory bodies.
  • Enhances visibility across all the plants which facilitate smarter and faster decision making and thereby reducing the number of raised CAPA’s or Change Controls or Deviations.
  • Simplifies the day to day work by standardizing methods and automating the repetitive tasks thereby boosting the performance and effectiveness of the entire auditing process.
  • Audit Evidence Capture: Capture evidence in real time and attach any type of common file, including videos, photos and sound recordings. The advantage of attaching evidence is that non-conformances can be viewed the same way by everyone and there’s no need for interpretation. This process will also eliminate the need to make lengthy notes to describe an issue.