AUDIT MANAGEMENT

Audit software provides integrated tracking systems and an automated workflow engine that streamlines all the steps in the audit lifecycle

AUDIT DEMO ON-DEMAND

Audit management software helps companies in regulated industries improve quality, reduce costs and identify operational and compliance risks. It allows auditing managers and regulatory personnel to manage the entire audit lifecycle and ensure proper resolution of issues.

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What Does Audit Management Mean for Life Science Companies?

Auditing in life science industries is essential to ensuring product quality, safety and compliance with regulatory requirements. Auditing plays a critical role in assessing the accuracy and reliability of the quality and manufacturing processes which are conducted by regulatory authorities, internal teams, third-party auditors, and customers to ensure that they adhere to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).

The life science industry conducts audits to ensure that products meet the highest standards, are safe for patients and consumers, and comply with regulatory requirements. Regulations dictate that each manufacturer must establish audit procedures, a systematic way to gather facts and objective evidence. The auditors cannot be directly responsible for the matters being audited.

Types of Audits for Life Science Companies

There are multiple audit topics, and the results from previous audits are evaluated to analyze patterns.

Regulatory audits

assess a firm’s adherence to established regulations and Current Good Manufacturing Practices.

Quality Management System (QMS) Audits

are internal to evaluate the effectiveness of the QMS.

Supplier audits

allow companies to audit their suppliers to assess their quality and compliance with relevant standards and regulations, as the quality of components and materials is critical.

Clinical trial audits

for pharmaceutical sites and data may be required to ensure that trials are conducted ethically and by good clinical practice (GCP) guidelines.

Process validation audits

ensure that manufacturing processes are validated, well-documented and consistently producing safe and effective products is a crucial aspect of these audits.

Risk management audits

evaluate the effectiveness of risk management systems to identify, assess and mitigate risks associated with the product.

Data integrity audits

of data management and data integrity practices are crucial, particularly in the pharmaceutical industry, to ensure the accuracy and reliability of data used for regulatory submissions.

Post-market surveillance audits

for medical devices may focus on monitoring and reporting post-market issues and implementing corrective and preventive actions.

Challenges for Internal and External Audits

During internal and external audits, the auditor documents information before, during, and after the audit. Documentation is needed to both record the results of the specific audit and support future tracking and trending efforts. Although these activities seem straightforward, they are fraught with inefficiencies, inconsistencies and redundancies, and require significant manual intervention at most companies.

Inefficient Manual Processes

Many organizations manually perform each process required for an audit.

For example, scheduling auditing teams across large organizations typically requires time-consuming phone calls or emails. Auditors in the field often use paper forms and manual spreadsheets to capture data which then must be transcribed into an electronic format for the final report; this reduces productivity and can lead to errors and missed deadlines. Another layer of documentation is added when auditors copy and paste information into rudimentary tracking systems for future trend analysis.

There is no reason to document the same thing multiple times, yet it happens in nearly every life science audit.

Ineffective Communications

Most audits require countless phone calls and emails to schedule, coordinate and bring together the members of the auditor and auditee teams. Follow-up also means many uncoordinated phone calls, emails and reminders, plus manual tracking and tallying of deadlines, status, due dates and delays.

This manual, redundant system doesn’t guarantee 100 percent success. In large organizations, many audits involving many stakeholders take place at any given time, which increases the chance of oversight failure or even audit failure. Worse yet, ineffective communication can give senior management a false sense of security while potentially serious issues are brewing in their organizations.

Incomplete or Inaccessible Documentation

All too often, organizations invest considerable resources into conducting audits only to find the documentation unusable later. This can happen for a number of reasons; documents may not be stored using the proper procedure or a supplier audit may be conducted at one site and now the results are needed at another.

Regardless of how it happens, poor documentation results in additional risk and, in many cases, rework. It is unacceptable to conduct audits only to have the documentation unavailable for downstream stakeholders, yet that is the very scenario in many organizations.

Siloed Processes / Disconnected Systems

Each audit may result in numerous findings and related CAPAs that must be addressed and managed.

When all of the elements of an audit program are manual or are not integrated with each other and the CAPA solution, critical information may not be transferred from one process to another in a timely manner. As a result, steps may be missed and required information not gathered.

Lack of integration is inefficient and often creates human error (due to manual transfer of data) which makes it difficult to close the loop and ensure that CAPAs adequately address audit-related issues.

Inconsistent Audit Results

Audit plans can vary broadly based on the type of audit and a variety of situational factors, including the auditor’s training, skills, and experience. Although companies acknowledge that some variation is inherent in the audit process, many companies draft audit plan ‘templates’ to drive more consistent results and ideally create a mechanism to identify trends across audits.

Unfortunately, over time the value is diluted since individual auditors tend to maintain their own local copies of the template and modify them based on their own preferences, resulting in the very inconsistencies the templates were designed to reduce. These inconsistencies can lead to misallocating focus and resources, or worse yet, failure to identify material deficiencies in areas not well covered.

Lack of Oversight

All the previously mentioned challenges—manual processes, poor communication and documentation, lack of integration, and inconsistent processes—lead to an inability to consolidate findings across the global organization and generate actionable reports.

The resulting lack of visibility increases the chance that auditors will be unable to see the bigger picture, including trends and high-risk areas, which can lead to costly problems or compliance issues.

Without accurate audit data, management lacks the information to make sound business decisions.

The Solution: Automated Audit Management System

What does a centralized and primarily automated auditing solution include? It should offer comprehensive automation, integration with the enterprise QMS, and consistent-yet-flexible templates. Specifically, a holistic, end-to-end solution will automate the following steps in the audit process: plan, schedule, perform, report, take actions and close audit.

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End-to-End technology

Today, leading life science companies are taking a more organized approach to audit management. They’re leveraging technology that enables holistic end-to-end automation across their entire auditing process and their global organization.

These solutions also integrate auditing capabilities as part of a larger quality management philosophy. This approach greatly reduces the time and cost necessary to complete audits and results in better information.

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Comprehensive Tools

An automated audit management solution incorporates electronic workflows, email notifications and collaboration tools to automate each step in the audit lifecycle. Different from paper-based systems, steps are not missed because an electronic system can easily track each task based on the type of audit.

Automated audit management systems also ensure that issues are resolved appropriately. Rather than having a report written in MS Word, the system can systematically and continuously track progress. As a result, these systems improve employee responsiveness and participation to reduce average cycle time.

EXPLORE THE TECHNOLOGY

Benefits for Quality Management

With an automated audit management solution employing flexible yet controlled templates with integrated quality management and CAPA processes, life science organizations can mitigate risk, increase productivity and reduce costs—yielding improved product quality.

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Mitigate Risk

Automating auditing processes helps ensure that all necessary steps are completed promptly and that no steps are missed. Such automation also minimizes the risk of human error due to data re-entry. Using such an automated system, life science organizations can avoid the risk that the audit will be inaccurate and subject to FDA oversight.

Successful audit programs identify the areas of highest risk within the enterprise and allow senior management to allocate resources appropriately.

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Increase Audit Productivity

Automating processes eliminates time-consuming manual and non-value-added efforts, such as repeated phone calls and emails for scheduling, manual data consolidation for reports, paper-based approval cycles, spreadsheet population for tracking/ trending, etc.

New technology also enables auditors to work in areas without internet access, such as airplanes or hotel rooms. As a result, automation enhances productivity.

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Reduce Costs

Using a digital audit management system can help organizations reduce costs by streamlining the audit process, which enhances efficiency, reduces time spent on manual tasks, and helps eliminate the need for paper-based documentation, thereby cutting printing and storage costs.

Improved data accuracy and real-time access to audit data minimize the costs associated with errors and enable timely corrective actions. Additionally, it supports standardized audit processes and checklists, reducing the risk of rework and discrepancies. By saving resources and cutting down cycle time, automated processes reduce the human capital required to perform the audit and the time needed to rectify the findings.

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Improve Product Quality

Closed-loop processes and comprehensive reporting improve the quality of audits to ensure that they can better identify — and mitigate — risks within an organization’s operations. These organizations can ultimately enhance product quality by improving the methods used in manufacturing processes.

Through data analytics and reporting, organizations can identify cost-saving opportunities and make informed decisions, while vendor and supplier audits are also streamlined, potentially reducing supply chain risk and improving negotiation outcomes.

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Increase Visibility

Automated audit solutions integrated with quality management systems readily allow access to many operational and quality metrics across the entire organization, which affords visibility to decision-makers.

This visibility results in quicker strategic and operational decision-making and streamlined processes and controls to support better product quality and reduced waste across the entire value chain.