Six steps to successful APR QPR automation

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Pharmaceutical companies have to submit a comprehensive Annual Product Review (APR in the U.S.) or Product Quality Review (PQR in Europe) to government health authorities.

As health authorities become increasingly stringent about regulatory reporting, the pharma industry must create a way to turn a host of manual activities performed by quality managers into a streamlined machine.

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Six steps to successful APR QPR automation

  1. 1. APR-PQR Automation Six Steps to Successfully Automate Product Quality Review Reports in Healthcare1 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  2. 2. HIGHLIGHTS Six Steps to Successful APR-PQR Automation Pharmaceutical companies have to submit a comprehensive Annual Product Review (APR in the U.S.) or Product Quality Review (PQR in Europe) to government health authorities. As health authorities become increasingly stringent about regulatory reporting, the pharma industry must create a way to turn a host of manual activities performed by quality managers into a streamlined machine.2 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  3. 3. Turning Away from Manual Reporting Issues with manually prepared product review reports Timely Data delivery Integrity Erroneous Missing data and products analysis Involvement of too many people Together, all these issues cry out for automating the APR-PQR process.3 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  4. 4. Six Steps to Automation Basel is a set of banking regulations put forth by the Basel Committee on Bank Supervision. Basel III is slated for 1. Design the 2. Define the 3. Identify Data Core Business implementation by DecemberGlobal Template 2019. Process Requirements 6. Plan for 4. Finalize Data 5. Conceptualize Phased Transformation the Solution Implementation Logic4 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  5. 5. Six Steps to Automation …contd. • Synthesize and harmonize each reporting process to establish a single, standard process that has acceptance from all future users of the automated solution. Step 1 • Create a standard, global report template that aligns with the technology used to draw the data. Step 2 • Define, identify and document every source system data field for better data accuracy. Step 3 • Arrive at a single “logic” based on best-in-class data transformation practices to ensure that analysis/reporting isnt subject to individual interpretations. Step 4 • Conceptualize the solution based on 3 primary components: Business process automation, Data transformation module & Integration with different source Step 5 systems and a statistical analysis tool. • Depending on your organization’s priorities and budget, it can be done as a single, complete implementation or in phases through pilot projects. Step 65 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  6. 6. Conclusion • Automate reporting to improve processes and elimnate errors. • The resulting streamlining and automation will create a huge improvement in productivity. • Process automation will allow quality managers to focus on true quality improvement projects. This is a complex transformation for pharmaceutical manufacturers, but proper planning will gradually turn the reporting process into another annual task that your team can accomplish accurately and with confidence.6 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  7. 7. For more details please visit the link below: http://www.wipro.com/Documents/resource- center/Six_Steps_to_Successful_APR-PQR_Automation.pdf7 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  8. 8. About Wipro Consulting Services Wipro Consulting Services helps companies solve todays business issues while thinking ahead to future challenges and opportunities. As a business unit of Wipro Technologies, one of the worlds leading providers of integrated consulting, technology and outsourcing solutions, we bring value to our clients through end-to-end business transformation – think, build and operate. Our model for the includes implementing lean process transformation, exploiting new technology, optimizing human capital and physical assets and structuring next generation partnering agreements that create value and win/win business outcomes for our clients. For more information, visit www.wipro.com/consulting or contact us by email at wcs.info@wipro.com8 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  9. 9. About Wipro Council for Industry Research Wipro set up the Council for Industry Research, comprised of domain and technology experts from the organization, to address the needs of customers. It specifically surveys innovative strategies that will help customers gain competitive advantage in the market. The Council, in collaboration with leading academic institutions and industry bodies, studies market trends to help equip organizations with insights to facilitate their IT and business strategies. For more information on the Research Council visit www.wipro.com/insights or mail wipro.insights@wipro.com9 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL
  10. 10. Thank You ©Wipro Limited, 2012. All rights reserved. For more information visit www.wipro.com No part of this document may be reproduced in whole or in part without the written permission of the authors. Wipro is not liable for any business outcome based on the views presented in this document. For specific implementation clients should take advise from their client engagement manager.10 © 2012 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL

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