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
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.
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 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.
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 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 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.
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.
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:
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
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.
Action Items/TasksThe auditee must respond to audit non-
conformities 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.
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.
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
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 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.
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.
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.
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.

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