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The Client: Leading Pharmaceutical Company

 

Overview

Traditional manual audit management tools such as spreadsheets, emails and paper documents were less efficient and overly time consuming in addition to offering limited visibility.

With the MetricStream Audit Management Solution, the client was able to automate and centralize all of their audit programs, streamline the complete audit cycle enabling greater visibility. The solution helped implement industry best practices for efficient audit execution, and ensured integration of the internal audit process with the risk and compliance management systems.

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Solution

Operating in an extremely complex and evolving business that pharmaceutical industry is today, the client, being a leader in the industry, carries the ethical and professional responsibility of ensuring the industry’s future compliance and success. As the core of its operations lies in a truly globalized sector where medicines are manufactured in developing countries with emerging markets and varying regulatory frameworks, the client has to consolidate and centralize a number of audits including that of manufactures, suppliers, service providers, contractors and their own operations. The need of the hour was a system to ensure that all of its required audits are planned, conducted, reported and followed up as appropriate to different audit situations in a consistent and systematic manner. Therefore, MetricStream provided the client with a highly flexible and configurable audit management solution, helping them consistently define, identify, record, manage, track, report and communicate multiple audit programs.

The MetricStream Audit Management Solution streamlines and centralizes multiple audit processes, and provides end-to-end functionalities for managing the complete audit lifecycle. It provides capabilities to efficiently plan, schedule and conduct audits, perform assessments using specific checklists, allows audit findings to be reviewed and analysed by a team, enables initiation of follow-up activities such as corrective/preventive actions when needed, and provides the ability to generate final report as well as monitor the entire process. The solution helps track a wide range of audit-related activities, data and processes in a single, comprehensive framework improving overall visibility. Closed-loop audits are supported with capabilities to establish and follow consistent procedures for issue capture, analyse audit issues or findings, track recommendations and action plans for all issues identified.

The solution platform has strong role-based security, automated workflows for review & approvals, information (document/work paper) management and reporting capabilities. The role-based access for all users with appropriate views and tabs for initiating actions, respond to events, manage to-do lists, and view reports and dashboards ensures quick and easy adoption.

Powerful analytics along with an issue tracking and reporting functionality give managers complete and real-time visibility into the audit system, and provides critical information for reducing the risk of noncompliance. Graphical executive dashboards and flexible reports with drill-down capability provide statistics by a variety of parameters such as by audited entity, schedule, results (pass/fail) and issues triggered.

 

Why MetricStream

The client chose MetricStream for the following reasons:

  • The client intends to use the solution to audit around 30 entities primarily including customer service; finance, accounting & treasury; global healthcare quality initiative, verifications program and more.
  • The solution is being used by over 1000 users across the globe to manage audit programs.
 
 
 
Challenges

The client, with its presence across the globe, was using manual audit management tools such as spreadsheets, emails and paper documents to conduct audits of its various internal processes. Working with organizations, professionals, and regulators around the world, the company needed to conduct regular audits covering a multitude of areas involving a good number of entities. Since, the traditional audit tools were less efficient and overly time-consuming, the client wanted to move from these methods to a comprehensive solution which can automate its entire audit and issue management processes. They wanted to implement an integrated, user-friendly solution that can manage the complete audit process, enhance visibility and efficiency, and reduce time spent on a range of audit-related tasks.

 

Why MetricStream?

MetricStream has a proven track record of successfully implementing its comprehensive Audit Management Solution at many of the largest and most well-known organizations around the globe.

The MetricStream solution offers the flexibility and configurability to be easily aligned to a company’s specific business needs. 

The solution helps manage all global audit activities from a single point of reference. It offers an integrated end-to-end internal audit functionality for managing the complete audit lifecycle.

The solution provides a cohesive approach to meet overall GRC objectives and also map itself to manage specific requirements of organizations.

Simple and easy-to-use solution which can be quickly adopted across the organization with minimal user training. The solution is readily configurable, easy to navigate and has an intuitively designed user interface. 

It follows a structured implementation process that incorporates all the solution requirements and meets agreed-upon timelines.

 

 

Benefits
  • An Integrated System for All Auditing Programs:
    The solution provides an integrated system to manage global audits of all of its internal processes. It provides a systematic and consistent risk-based audit process across units, divisions, global locations and sites.
  • Greater Audit Visibility:
    The solution, with its centralized dashboards, risk heat maps, and advanced reporting capabilities, provides enterprise-wide visibility into the status of audit issues, controls, and tracking metrics.
  • Improves Efficiency, Time Management and Communication:
    The solution significantly increases the efficiency of the audit process and shortens cycle times as tasks are automatically assigned and tracked from one stage to the next, in addition to improving communication and teamwork on complex audit processes across departments and functional areas.
  • Accelerates and Streamlines Audit Cycle:
    The solution offers a slew of advanced capabilities such as time tracking, built-in remediation workflows, email-based notifications and alerts, and offline functionalities for conducting audits at remote field sites, helping accelerate the overall process.
  • Flexibility to Meet Business Needs:
    An adaptive and flexible data model with configurable forms, fields, reports and workflows, enabling businesses to easily model and configure complex audit projects.

 

 

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