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The Ultimate Cheat Sheet to GMP Compliance

November 9, 2016 / by Emily Ysaguirre

Before selecting automated compliance management softwarepharma_training.jpg, consider your needs. Reflect over past business practices and how your operations are currently running. From there, you will be able to determine the type of solution that will best fit your needs.

Here are a few things to consider.

Does this software truly fit my needs?

Is it flexible? Many vendors advertise flexible solutions, however they may not truly be. If you’re looking to expand on already built practices, the last thing you would want to do is use downtime to configure a new system. Look for a solution that offers the ability to custom design workflows, offers scalability and localization capabilities and does not require programming.

Does this solution offer reporting?

Reporting is a highly important tool. It allows information to be brought to the surface and create correlations between trends across the entire enterprise. Visibility into common business processes is key to fostering change within any organization, even yours. Any adverse events, corrective actions taken or needed to be taken along with changes will all be combined into a single and holistic report. This allows any user from any location to see the most updated and relevant information to their search.

Are there built-in processes to achieve operational excellence?

Sure, compliance is great but operational excellence is even better. If you have a system that can communicate with different modules this will enhance the overall visibility and collaboration within the enterprise. This enables managers to see into trends and adverse events that occur throughout an enterprise in a concise, colorful report.

Is this solution scalable?

In your search for a solution you may find that a vendor uses the term, “scalable.” However, you’ll want to know just how scalable the solution is. As companies become more successful, they often come to find they will need more locations, as well as employees. Eventually, this will impact your solution. A scalable solution will not impact growth—in fact, it will grow with you. The proper solution can support your system without running out of bandwidth.

Hopefully this guide aids you in your search for complete and total quality and compliance. Of course, you will want the most value for your money. This requires some homework. In addition to flexibility, scalability, reporting and built-in processes you may want to see if a vendor offers a trial. This is just like any other investment…for example, car shopping. You’ll always want to test the product before bringing it home! Best of luck and I hope to see you on the right side of quality soon.

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Topics: Life Sciences