Automated Audit Management:

Enabling Life Science Companies to Mitigate Risk and Increase Audit Productivity

WHITE PAPER

Executive Summary
In response to recent high-profile product safety issues, the quantity and breadth of internal audits and external audits of suppliers and outsourcing partners have increased significantly. With stepped up audits, inefficient, manual, siloed processes are now causing significant problems, including: poor communications and scheduling; inefficient use of auditor and auditee resources; inconsistent audit output; lack of visibility and oversight into trends; and difficulty in ensuring appropriate follow-up on corrective and preventive actions (CAPAs). All these issues can have an adverse impact on operational effectiveness and product quality. Today, however, best-in-class organizations are adopting automated and integrated audit management solutions to address these challenges. This whitepaper describes how audit management solutions enable life science companies to reduce audit time and cost, mitigate risk and ultimately help improve product quality and safety. It also suggests elements to consider when choosing an audit management solution.

The Role of Auditing in Life Science Companies

In response to numerous recent product-related incidents that have impacted consumer safety, organizations are ratcheting up their efforts to audit and inspect the quality of their operations both internally and throughout the supply chain network of partners and suppliers. Of course, compliance audits have always been used to assess a firms adherence to established regulations and standards. Regulatory bodies use audits for enforcement purposes while companies use audits to assess preparedness for external audits, and to proactively identify risk across the enterprise. These audits focus on people, processes, and technology and how they collectively support compliance both in theory and in practice in the form of quality records and documentation. Internal auditors at life science organizations also perform various types of performance audits (which are also referred to as management audits) to evaluate the effectiveness of operational rules designed by the company, as well as the suitability of those rules for achieving an organizations goals. As such, an internal audit can help an organization evaluate which processes and operations are working and which are not and find ways to better fulfill its objectives. There must be a basis for an audit and a systematic way to gather facts and objective evidence. Regulations dictate that each manufacturer must establish procedures for audits, and then have individuals who do not have direct responsibility for the matters being audited, conduct the audit. An auditor compares the objective evidence with the requirements and makes observations, which are then analyzed to determine whether any systemic issues exist and ultimately assess the risk of the observation or finding. Its important to note that while companies use many different terms for these steps, observation, finding, conclusion, ruling, discrepancy, deviation, etc, they all follow the same fundamental process.

The sidebar, Types of Life Science Audits describes some of the compliance and performance audits for which life science companies must prepare and/or perform. The focus of the audit can be a product or service, a process, a system or an entire location/facility. Results from previous audits are evaluated to analyze patterns. Some audits are focused (for example, an audit may review the packaging process at pharmaceutical plant) and some are broader (such as how well an entire factory complies with a particular regulation).

Types of Life Science Audits

Life science companies are subject to a wide range of audits. The following are a few of the types of audits commonly performed for life science organizations.

ISO Quality Systems Audit Regulatory Audits Contractor/Supplier/Vendor Audits Computer System Validation Audits Risk Assessments Design Control Audit Internal Controls/Process Validation Standards of Business Conduct Clinical Audits for GCP Compliance Method Validation Audits

Challenges Internal and External Auditors Face When Conducting 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.

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 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.

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.

Inconsistent Audit Results

Audit plans can vary broadly based on the type of audit and a variety of situational factors, including the auditors training, skills, and experience. Although companies acknowledge that some variation is inherent in the audit process, many draft audit plan templates in an attempt 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.

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 doesnt 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.

Lack of Oversight
All of 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.

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.

The Solution: Automated End-to-End Audit Management

Today, best-in-class life science companies are taking a more organized approach to audit management. Theyre 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.

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.

Comprehensive Automation
An automated audit management solution incorporates electronic workflows, email notifications and collaboration tools to automate each step in the audit lifecycle. Unlike paper-based systems, no steps are 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. Specifically, a holistic, end-to-end solution will automate the following steps in the audit process:

auditing effort; specifying which processes and subprocesses will be audited, as well as the results from the previous audit; defining the audits scope, objectives and agenda; determining which audit template to use for performing the audit; developing a chronology of the audit from start to finish; and determining the types of resources and documents needed from the process owner. SchedulingAn automated audit system can simplify the process of scheduling audit dates, including automatic reminders to initiate and assign audits to ensure that tasks dont fall through the cracks. Automated scheduling is particularly useful when multiple audits are occurring at the same time because it eliminates personnel conflicts. Robust reports can subsequently be produced that allow key stakeholders to achieve a macro view of audit activity across the enterprise, understand auditor utilization, and identify proper workload balancing and conflicts. Performing the auditAudit management systems can help the lead auditor manage the overall audit process, including gathering required data; recording audit findings and objective evidence for each question; issuing action items to address discrepancies; managing and communicating any changes to the audit plan; communicating progress to all stakeholders; and ensuring that the schedule stays on track. Leading-edge audit management systems allow auditors to electronically document audit results whether they have internet connectivity or not at a customer site, on an airplane, or at their desk. This allows auditors to document everything once (including all of the classifications management needs for future tracking and trending), and eliminates the copy/paste challenges common in audits. This capability is enabled by modern lightweight technology that allows auditors to conduct work while disconnected from the internet. This approach is a complete departure from legacy work methods like MS Word, which are loosely controlled and emulate the manual processes audit management systems are striving to replace. ReportingOnce the appropriate criteria are evaluated, auditors can generate a formatted report that includes the written audit observations of good practices, and risks and problems identified. This report forms the basis of the discussion about the audit results and findings. An audit management system provides reporting capabilities that also generate trends and metrics against data gathered across reports. In systems that track multiple auditing groups, risk and prioritization can be rolled up and used to determine prioritization of resources across groups, not just on a siloed basis within each group.

Plan

Schedule

Perform Audit

Report

Action Tasks

Close-out

PlanningProper planning results in an audit that flows smoothly and logically, minimizing backtracking and repeat visits that take time and effort without adding value. An audit management system can aid with planning processes that include assigning appropriate auditors to lead and assist with the

Action Items/TasksThe auditee must respond to audit nonconformities by their respective due dates. The response must include a probe into the root cause, a proposed corrective action and a completion date. An integrated CAPA management solution is highly recommended to effectively and efficiently manage the CAPA process based on the criticality and the risk factor of the finding. In the case of supplier audits, the offline capabilities mentioned above now allow auditors to email the audit findings to the auditee. The auditee can respond electronically, which helps ensure that the response fulfills the expectations of the organizations quality system. Close-OutAn audit can be completed and closed-out once all the action items are addressed, and the responses and appropriate sign-offs are received. A final audit report can be generated to document the audit for inspection, or the audit management system can be used as the official system of record.

Consistent Templates
Consistency is critical to help auditors identify the areas of highest risk across the organization. In order to obtain this consistency, the overall auditing process must contain the same core elements regardless of the auditee or auditor. To reduce variation and achieve consistent results, a best practice is the use of standardized templates and processes with the appropriate subject matter for the specific audit. At the same time, different types of audits track different issues. Distinctions exist in how visible audit results should be; internal audits need to be tracked and be visible, while supplier audits tend to be tightly controlled to eliminate the chance of confidential information being passed to a competitor. The best practice for addressing these seemingly contradictory requirements is for organizations to use flexible templates across their global operations. Template design can ensure that audits are conducted to a particular standard and all requirements are followed. At the same time, organizations can adjust these templates to address business distinctions between audit types, and even target them to specific areas for particular audits. When tailoring templates, each organization needs to define the appropriate level of control it requires. Using templates, organizations can:
Increase consistency to allow for uniform enterprise-wide audit

Integration
The automated audit solution should seamlessly integrate all of the related individual quality systems and processes to allow life science organizations to create a closed-loop process, from scheduling and managing the audit to closing out the CAPA. When information is passed from one step to the next seamlessly and without manual oversight, manual data re-entry and the accompanying errors are eliminated, which speeds the audit process. Auditing point solutions fail the organization because of the inherent disconnect in data and risk prioritization between audits and the other inputs to the CAPA system namely complaints and nonconformities. Effective quality systems require the ability to track and trend across multiple data sources to identify themes, such as common root causes or areas with higher risk, and this analysis becomes nearly impossible in situations where the data collected is designed for different purposes. Integrated systems alleviate this concern by providing a centralized data repository that allows for easier reporting, queries and analysis. This central data repository enables global and local trending, which simplifies root cause identification across the entire quality system. This centralized information helps the organization generate greater returns on audit program investments by giving the organization a clearer picture of risk areas and allowing it to focus resources on the areas of greatest risk.

analytics and prioritization

Enable analytics across audit programs by leveraging

comparisons of similarities
Adapt the audit to fit organizational processes

Access to Data
Audit data must be carefully managed to protect the companys interests and contractual agreements with suppliers. At the same time, failure to distribute data to the appropriate people results in ineffective business decisions. A carefully designed permissions model ensures audit data is disseminated appropriately within your organization.

Benefits
With an automated audit management solution employing flexible-yet-controlled templates with integrated quality management and CAPA processes, life science organizations can benefit by mitigating risk, increasing productivity, reducing costsyielding improved product quality.

Mitigate Risk
Automating auditing processes helps ensure that all necessary steps are completed in a timely fashion 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 minimize 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.

Increase Visibility
Automated audit solutions integrated with quality management systems readily allow access to a multitude of 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 lead to better product quality and reduced waste across the entire value chain.

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.

Conclusion
Todays best-in-class enterprises are moving from manual, disparate and siloed audit management to centralized and automated audit management solutions. With capabilities such as complete automation, offline access, integration and flexible templates, these automated solutions improve auditors productivity, provide more accurate results, and make it easier to identify trends across the global organization, thus, helping to improve operational processes and controls. By leveraging an automated audit management system with an integrated CAPA system, these organizations ensure that appropriate remediation is implemented properly in a timely manner. As a result of this integrated end-to-end solution, these enterprises reap the benefits of lower audit costs, greater productivity, and less operational risk, which ultimately lead to better product quality.

Reduce Costs
By saving resources and cutting down cycle time, automated processes reduce the human capital required to perform the audit and the time needed to conduct and complete the findings rectification.

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 the operations of an organization. By improving the methods used in manufacturing processes, these organizations can ultimately improve product quality.

Sparta Systems global quality management solutions enable high-value organizations to safely and efficiently deliver products and services to market. Its TrackWise Enterprise Quality Management Software, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in New Jersey and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer products markets.

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