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 The sidebar, Types of Life Science Audits describes some of
the compliance and performance audits for which life science
Companies companies must prepare and/or perform. The focus of the audit
In response to numerous recent product-related incidents that
can be a product or service, a process, a system or an entire
have impacted consumer safety, organizations are ratcheting up
location/facility. Results from previous audits are evaluated to
their efforts to audit and inspect the quality of their operations
analyze patterns. Some audits are focused (for example, an audit
both internally and throughout the supply chain network of
may review the packaging process at pharmaceutical plant) and
partners and suppliers.
some are broader (such as how well an entire factory complies
with a particular regulation).
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
Types of Life Science Audits
audits focus on people, processes, and technology and how they
collectively support compliance both in theory and in practice Life science companies are subject to a wide
in the form of quality records and documentation. range of audits. The following are a few of the types
of audits commonly performed for life science
Internal auditors at life science organizations also perform organizations.
various types of performance audits (which are also referred to as
management audits) to evaluate the effectiveness of operational ISO Quality Systems Audit
rules designed by the company, as well as the suitability of those
rules for achieving an organizations goals. As such, an internal Regulatory Audits
audit can help an organization evaluate which processes and
Contractor/Supplier/Vendor Audits
operations are working and which are not and find ways to
better fulfill its objectives. Computer System Validation Audits

There must be a basis for an audit and a systematic way to Risk Assessments
gather facts and objective evidence. Regulations dictate that
Design Control Audit
each manufacturer must establish procedures for audits, and
then have individuals who do not have direct responsibility Internal Controls/Process Validation
for the matters being audited, conduct the audit. An auditor
compares the objective evidence with the requirements and Standards of Business Conduct
makes observations, which are then analyzed to determine
Clinical Audits for GCP Compliance
whether any systemic issues exist and ultimately assess the risk
of the observation or finding. Its important to note that while Method Validation Audits
companies use many different terms for these steps, observation,
finding, conclusion, ruling, discrepancy, deviation, etc, they all
follow the same fundamental process.
Challenges Internal and External Auditors Siloed Processes / Disconnected Systems
Each audit may result in numerous findings and related CAPAs that
Face When Conducting Audits must be addressed and managed. When all of the elements of an
During internal and external audits, the auditor documents audit program are manual or are not integrated with each other
information before, during, and after the audit. Documentation and the CAPA solution, critical information may not be transferred
is needed to both record the results of the specific audit from one process to another in a timely manner. As a result, steps
and support future tracking and trending efforts. Although may be missed and required information not gathered. Lack of
these activities seem straightforward, they are fraught with integration is inefficient and creates human error (due to manual
inefficiencies, inconsistencies and redundancies, and require transfer of data) which makes it difficult to close the loop and
significant manual intervention at most companies. ensure that CAPAs adequately address audit-related issues.

Inefficient Manual Processes Inconsistent Audit Results

Many organizations manually perform each process required for Audit plans can vary broadly based on the type of audit and
an audit. For example, scheduling auditing teams across large a variety of situational factors, including the auditors training,
organizations typically requires time-consuming phone calls or skills, and experience. Although companies acknowledge that
emails. Auditors in the field often use paper forms and manual some variation is inherent in the audit process, many draft audit
spreadsheets to capture data which then must be transcribed into plan templates in an attempt to drive more consistent results
an electronic format for the final report; this reduces productivity and ideally create a mechanism to identify trends across audits.
and can lead to errors and missed deadlines. Another layer Unfortunately, over time the value is diluted since individual
of documentation is added when auditors copy and paste auditors tend to maintain their own local copies of the template
information into rudimentary tracking systems for future trend and modify them based on their own preferences, resulting in
analysis. There is no reason to document the same thing multiple the very inconsistencies the templates were designed to reduce.
times, yet it happens in nearly every life science audit. These inconsistencies can lead to misallocating focus and
resources, or worse yet, failure to identify material deficiencies in
Ineffective Communications areas not well covered.
Most audits require countless phone calls and emails to schedule,
coordinate and bring together the members of the auditor and Lack of Oversight
auditee teams. Follow-up also means many uncoordinated All of the previously mentioned challenges manual processes,
phone calls, emails and reminders, plus manual tracking and poor communication and documentation, lack of integration,
tallying of deadlines, status, due dates and delays. This manual, and inconsistent processes lead to an inability to consolidate
redundant system doesnt guarantee 100 percent success. In large findings across the global organization and generate actionable
organizations, many audits involving many stakeholders take place reports. The resulting lack of visibility increases the chance that
at any given time, which increases the chance of oversight failure auditors will be unable to see the bigger picture, including
or even audit failure. Worse yet, ineffective communication can trends and high risk areas, which can lead to costly problems or
give senior management a false sense of security while potentially compliance issues. Without accurate audit data, management
serious issues are brewing in their organizations. lacks the information to make sound business decisions.

Incomplete or Inaccessible Documentation The Solution: Automated End-to-End Audit

All too often, organizations invest considerable resources into
conducting audits only to find the documentation unusable later.
Management
This can happen for a number of reasons; documents may not Today, best-in-class life science companies are taking a more
be stored using the proper procedure or a supplier audit may be organized approach to audit management. Theyre leveraging
conducted at one site and now the results are needed at another. technology that enables holistic end-to-end automation across
Regardless of how it happens, poor documentation results in their entire auditing process and their global organization. These
additional risk and, in many cases, rework. It is unacceptable to solutions also integrate auditing capabilities as part of a larger
conduct audits only to have the documentation unavailable for quality management philosophy. This approach greatly reduces
downstream stakeholders, yet that is the very scenario in many the time and cost necessary to complete audits and results in
organizations. better information.
What does a centralized and primarily automated auditing auditing effort; specifying which processes and subprocesses
solution include? It should offer comprehensive automation, will be audited, as well as the results from the previous audit;
integration with the enterprise QMS, and consistent-yet-flexible defining the audits scope, objectives and agenda; determining
templates. which audit template to use for performing the audit; developing
a chronology of the audit from start to finish; and determining
Comprehensive Automation the types of resources and documents needed from the process
An automated audit management solution incorporates owner.
electronic workflows, email notifications and collaboration tools
to automate each step in the audit lifecycle. Unlike paper-based SchedulingAn automated audit system can simplify the
systems, no steps are missed because an electronic system can process of scheduling audit dates, including automatic reminders
easily track each task based on the type of audit. Automated to initiate and assign audits to ensure that tasks dont fall
audit management systems also ensure that issues are resolved through the cracks. Automated scheduling is particularly useful
appropriately. Rather than having a report written in MS Word, when multiple audits are occurring at the same time because it
the system can systematically and continuously track progress. eliminates personnel conflicts. Robust reports can subsequently
As a result, these systems improve employee responsiveness and be produced that allow key stakeholders to achieve a macro
participation to reduce average cycle time. view of audit activity across the enterprise, understand auditor
utilization, and identify proper workload balancing and conflicts.
Specifically, a holistic, end-to-end solution will automate the
following steps in the audit process: 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
Plan discrepancies; managing and communicating any changes to
the audit plan; communicating progress to all stakeholders; and
ensuring that the schedule stays on track.

Schedule 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
Perform Audit
(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
Report
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.
Action Tasks
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.
Close-out
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
PlanningProper planning results in an audit that flows against data gathered across reports. In systems that track
smoothly and logically, minimizing backtracking and repeat multiple auditing groups, risk and prioritization can be rolled up
visits that take time and effort without adding value. An audit and used to determine prioritization of resources across groups,
management system can aid with planning processes that not just on a siloed basis within each group.
include assigning appropriate auditors to lead and assist with the
Action Items/TasksThe auditee must respond to audit non- Consistent Templates
conformities by their respective due dates. The response must Consistency is critical to help auditors identify the areas of
include a probe into the root cause, a proposed corrective action highest risk across the organization. In order to obtain this
and a completion date. An integrated CAPA management solution consistency, the overall auditing process must contain the same
is highly recommended to effectively and efficiently manage core elements regardless of the auditee or auditor. To reduce
the CAPA process based on the criticality and the risk factor of variation and achieve consistent results, a best practice is the use
the finding. In the case of supplier audits, the offline capabilities of standardized templates and processes with the appropriate
mentioned above now allow auditors to email the audit findings subject matter for the specific audit.
to the auditee. The auditee can respond electronically, which
helps ensure that the response fulfills the expectations of the At the same time, different types of audits track different
organizations quality system. issues. Distinctions exist in how visible audit results should be;
internal audits need to be tracked and be visible, while supplier
Close-OutAn audit can be completed and closed-out once all audits tend to be tightly controlled to eliminate the chance of
the action items are addressed, and the responses and appropriate confidential information being passed to a competitor.
sign-offs are received. A final audit report can be generated to
document the audit for inspection, or the audit management The best practice for addressing these seemingly contradictory
system can be used as the official system of record. requirements is for organizations to use flexible templates across
their global operations. Template design can ensure that audits
Integration are conducted to a particular standard and all requirements
The automated audit solution should seamlessly integrate all are followed. At the same time, organizations can adjust these
of the related individual quality systems and processes to allow templates to address business distinctions between audit types,
life science organizations to create a closed-loop process, from and even target them to specific areas for particular audits.
scheduling and managing the audit to closing out the CAPA.
When information is passed from one step to the next seamlessly When tailoring templates, each organization needs to define
and without manual oversight, manual data re-entry and the the appropriate level of control it requires. Using templates,
accompanying errors are eliminated, which speeds the audit organizations can:
process.
Increase consistency to allow for uniform enterprise-wide audit
Auditing point solutions fail the organization because of the analytics and prioritization
inherent disconnect in data and risk prioritization between audits  Enable analytics across audit programs by leveraging
and the other inputs to the CAPA system namely complaints comparisons of similarities
and nonconformities. Effective quality systems require the ability
Adapt the audit to fit organizational processes
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 Access to Data
collected is designed for different purposes. Audit data must be carefully managed to protect the companys
interests and contractual agreements with suppliers. At the same
Integrated systems alleviate this concern by providing a time, failure to distribute data to the appropriate people results in
centralized data repository that allows for easier reporting, queries ineffective business decisions. A carefully designed permissions
and analysis. This central data repository enables global and model ensures audit data is disseminated appropriately within
local trending, which simplifies root cause identification across your organization.
the entire quality system. This centralized information helps
the organization generate greater returns on audit program
Benefits
investments by giving the organization a clearer picture of risk
areas and allowing it to focus resources on the areas of greatest With an automated audit management solution employing
risk. 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 Increase Visibility
Automating auditing processes helps ensure that all necessary Automated audit solutions integrated with quality management
steps are completed in a timely fashion and that no steps are systems readily allow access to a multitude of operational and
missed. Such automation also minimizes the risk of human error quality metrics across the entire organization, which affords
due to data re-entry. Using such an automated system, life science visibility to decision makers. This visibility results in quicker
organizations minimize the risk that the audit will be inaccurate strategic and operational decision making, and streamlined
and subject to FDA oversight. Successful audit programs identify processes and controls lead to better product quality and reduced
the areas of highest risk within the enterprise and allow senior waste across the entire value chain.
management to allocate resources appropriately.
Conclusion
Increase Audit Productivity
Automating processes eliminates time-consuming manual and Todays best-in-class enterprises are moving from manual,
non-value-added efforts, such as repeated phone calls and emails disparate and siloed audit management to centralized and
for scheduling, manual data consolidation for reports, paper-based automated audit management solutions. With capabilities
approval cycles, spreadsheet population for tracking/trending, etc. such as complete automation, offline access, integration and
New technology also enables auditors to work in areas without flexible templates, these automated solutions improve auditors
internet access, such as airplanes or hotel rooms. As a result, productivity, provide more accurate results, and make it easier
automation enhances productivity. to identify trends across the global organization, thus, helping
to improve operational processes and controls. By leveraging an
Reduce Costs automated audit management system with an integrated CAPA
By saving resources and cutting down cycle time, automated system, these organizations ensure that appropriate remediation is
processes reduce the human capital required to perform the implemented properly in a timely manner.
audit and the time needed to conduct and complete the findings
rectification. As a result of this integrated end-to-end solution, these enterprises
reap the benefits of lower audit costs, greater productivity, and
Improve Product Quality less operational risk, which ultimately lead
Closed-loop processes and comprehensive reporting improve to better product quality.
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.

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