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Oct 27, 2015

Still Using Paper for Audits? Here’s Why You Need to Automate


A recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries.

Although these are high-tech industries, the control and regulation of day-to-day processes is still being done manually—and any manual process has weaknesses. When considering the benefits that can be achieved by automating auditing processes, it’s hard to see why more life science companies aren’t looking at what automated systems have to offer. Let’s take a closer look at just a few of the benefits automated audit processes can bring.

Improved Audit Scheduling

Why would an auditor keep track of several diaries manually when an automated audit solution would allow them to update their own availability in a global calendar? A software system that provides conflict warnings could ensure that auditors will never be double booked again. Powerful scheduling tools such as drag-and-drop visual editing provide the easiest possible method of arranging busy schedules. The same goes for functionality that sends automatic notifications of appointments and updates to individual auditors.

Simplified Execution of Audits

Quality and regulatory professionals shouldn’t have to waste time compiling multiple reports from different auditors. A solution that provides a virtual audit workspace allows multiple auditors to work together, either from a desktop or a mobile interface. Other useful features, such as the availability of online checklists, ensure that there aren’t mountains of paperwork to sort though. A top-notch audit software solution should allow professionals to issue draft audit reports from fully customizable templates and collaborate on them from within the workspace. 



                                        This article is related to the Video: MasterControl Audit Overview.


Approvals Made Easy

Getting approvals can be an enormously time consuming task; think of all the time spent moving paper reports around and chasing after the appropriate personnel for sign-offs. With a powerful software solution, default approval groups can be set up for each type of audit and notifications are sent automatically when a report needs approval. It makes who has signed off immediately evident and shows any missing signatures from right within the electronic record.

Controlled Response Collection

Still spending time sending out individual requests for responses, or making sure only the right people see the whole report? An electronic audit solution can automatically send response collection tasks to internal and external users and should be configurable to allow (or prevent) access to the full report, or just to a specific observation. Response status can be readily monitored and followed up on from the audit workspace or response entry documents can be sent out offline.

Correctly Defining Actions and Reducing Redundant Efforts

How much time do you waste manually reentering audit information into a new quality event? If you were working with a fully integrated electronic quality management system, the ability to launch a CAPA, SCAR or other quality event would be one simple click away. A first-class audit system should also allow you to customize your quality events or choose from an assortment of best practice out-of-the-box solutions.

Superior Analysis, Tracking and Trending

Which is your most problematic process? How many of your vendors had major findings in the last 12 months? Do you really know your all your weak points for that upcoming regulatory inspection? With an automated audit solution, you will easily be able to find the answer to all of these and, depending on the quality of the solution, many more questions.

Learn More about Automating Audit Processes

If you would like to learn more about the versatile tools currently available to companies looking to streamline their audits, take a look at this video that provides an overview of the robust MasterControl Audit™ software solution. MasterControl also offers a complimentary Audit Toolkit that provides a host of resources such as white papers and videos that have been specifically created to help organizations improve their audit processes. 


Steve Harrison has over 20 years' experience in the IT industry and has worked in a number of fields including legal, telecommunications, electronic transaction processing, and quality assurance. He started his career as a software engineer with several small firms, gaining exposure and building experience in many aspects of technology and industry. In 2005, he joined AMG IT Systems, which was acquired by MasterControl in 2007. He took over as Development Manager for the European division of MasterControl and later moved into the Product Management Team. He is currently the technical product manager for all auditing solutions.





[1] Quality Management System Benchmark 2015 – Vendor Software System Use, August 2015, copyright 2015 by Mikki Willett, Quality & Regulatory Network. 









Watch A Related Video:

Passing Audits and Inspections with MasterControl


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White Paper: The Top 5 Benefits of Electronic GLP Audit Management
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