Audit Management

Audit Management Software

Pharmaceutical companies place a high value on auditing. Conducting GMP audits in the life sciences industry has the goal of determining whether or not Good Manufacturing Practices are being followed and making recommendations for any required changes. To assist pharmaceutical and biotech companies to improve their quality systems, audit checklists identify weaknesses.

 Objectives of Audits in GMP Environment

An audit has been established to be an effective method of assessing GMP compliance with these three quality system objectives:

  • Verification of the organization’s control systems and assuring that GMP standards are followed through these controls.
  • Identifying possible issues and taking remedial action to remedy them, as well as measures to avoid recurrence.
  • Increasing consumer trust in drug products and drug substances and ensuring customer satisfaction.

GMP Audits Types and their Objectives

In the regulated industry, such as pharmaceutical and biotech, there are four types of audits:

Internal audits, customer audits, vendor audits, and regulatory audits carried out by the US FDA, MHRA, and WHO

  • Vendor audits are needed to acquire the appropriate raw materials from authorized suppliers in order to ensure drug product realization.
  • Stabilize your business by conducting regular assessments of your operations and processes. Internal audits may be used to perform such periodic assessments. The findings of these internal audits are valuable feedback for continual development.

GMP Audits in Life Sciences Industry are conducted in Three Stages:

  • Stage 1 – Planning and initiating the audit
  • Stage 2 – Conducting the audit in the facility
  • Stage 3 – Filing the audit report, identifying corrective and preventive actions, following up, running effectiveness checks, and closing

Challenges in Manual GMP Audit Scheduling and Tracking findings

Audit Planning and Scheduling

Audit planning and scheduling are difficult for organizations that operate across several locations and have multiple facilities and branches. When handled manually, creating an annual audit calendar and distributing the audit plan to the relevant departments along with necessary reminders, is a taxing task.

Audit Execution Activities

Throughout the year, organizations are subjected to several audits by various regulatory authorities and customers, which may lead to delays in acting on the findings.

Data Security

There are several different types of data involved in an audit, including audit observations (findings), auditee response, and audit reports. Paper-based record management is inherently vulnerable to data security concerns, and it is quite difficult to ensure the security and confidentiality of sensitive data.

Data Archival

Archiving prior audit records helps the organization in keeping reference documents that give a clear understanding of the mistakes that happened in previous audits and how to improve on them. It is important to properly archive these historical data to make them readily accessible when needed.

GMP Audit Scheduling Software

AmpleLogic Audit Management Software helps organizations to efficiently perform audits by automating and simplifying the Audit Management process, as well as dealing with today’s paper-based management issues.

The solution increases product quality monitoring and process improvements by removing the inadequacies of a paper-based method.

Our LOW CODE Platform was used to create the Amplelogic Audit Management Software

Features of GMP Audit Management Solution

Hassle-free Audit Planning and Scheduling

  • Audit planner and audit calendar make it simple to schedule audits. Also, while planning the audit, the audit agenda can be determined.
  • The auditee can be informed about the audit schedule and audit agenda via email notification from the software program. In the event of an internal audit, the auditee will have the option to modify the schedule by providing a valid cause.

Auditor Information

  • The AmpleLogic Audit Management system collects essential information about Internal Auditors such as the number of years the auditor has been in the profession, their level of qualification, and their specializations. This feature emphasizes the notion that audits can substantially benefit a company when performed by an expert auditor with the industry knowledge required for thorough audits.
  • With the solution, a certificate for internal auditors can be created to recognize the auditor’s expertise, which is important in completing the audit.
  • In the event of Regulatory Audits, auditor information is also kept in order to prepare for any future audits from the same auditor.

Flawless Audit Execution

  • The software captures important data such as audit results and auditee responses, ensuring that this data is safe and only available to authorized individuals.
  • The Audit Checklist is a critical tool in audit implementation. Users can submit the audit checklist into the Audit Management system while gathering audit observations.
  • AmpleLogic Audit Management also features a qualitative grading system (Minor/Major/Critical) to indicate the gravity of audit findings.

Integration with CAPA module

  • On the completion of the audit, the results are transferred to appropriate departments in the pharmaceutical plant.
  • The appropriate department(s) will communicate back with the root cause and recommend necessary corrective and preventive action.
  • The AmpleLogic Low Code-Based Audit Software can connect with the CAPA management module. CAPAs can be launched and closed using the CAPA Management module, with status monitoring enabled in the Audit Management system.
  • Specific results will be closed once all CAPAs have been completed. The Audit Report will be closed after all findings have been resolved.

Graphical Reports

  • The solution provides a variety of graphical reports, such as category-specific audits, criticality-specific audit findings reports, department-specific audit findings, closure status reports of findings, and so on. Actionable information is provided for the management in such intuitive reports, allowing them to better accomplish their goals and ensure a successful audit.
  • The management will benefit from the repetition of the findings report by concentrating more on a few key areas.

Advantages of  GMP Audit Management Software

Managing Audit End-to-End

  • An electronic audit management system manages the full audit life cycle, from audit planning and audit initiation through audit findings, action item implementation, and audit closure.
  • With an appropriate approval process and review system in place, a pre-defined workflow makes such a time-consuming job easier.

Simplified Audit Scheduling

  • A recurring activity, such as auditing, involves planning and scheduling audits throughout the year. Due to the complexity of manual operations, there are chances that the concerned departments may not get timely notifications. An audit management software sets an automatic reminder on the schedule and allows teams to be ready for audit ahead of time.

Centralized Access

  • An Automated Audit Management Solution serves as a central repository for all audit (internal/external/customer and regulatory) information, minimizing the risk of losing audit findings, responses, or audit reports.

Integration with other Quality Modules

  • The smooth integration of Audit Management software with other quality modules, particularly CAPA Management, enables auditing to accomplish one of its primary goals, which is a consistent advancement.

Intuitive reports

  • An automated system can easily create various audit reports and trends, which could serve as an invaluable toolset for efficient auditing

Our GMP Audit Software will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA,SFDA,NAFDAC, MEDSAFE,MHLW, MCAZ, SWISSMEDIC,KFDA and MoH

Other industries that can take advantage of GMP Audit Tracker

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

To learn more about how AmpleLogic Audit Management System may assist your organization, please feel free to contact us.