Quality Management - 12 July 2017
In this blog, I will discuss the benefits of buying out of the box software. In my previous blog in this series, I discussed thinking out of the box in the Life Sciences industry. In my next blog, I will discuss how you can do both and be successful.
Purchasing out of the box software has definite benefits. It means that the software is ready to use with minimal configuration or customization required. The software has also been thoroughly tested and validated.
Out of the box software is generally less costly and incorporates common industry best practices. A full validation package is available so that additional validation by the customer may not be required. Compliance with 21CFR Part 11 and alignment with CGMP’s is assured. The implementation timeline is shorter and the return on investment (ROI) is quicker as a result.
"...an important factor to keep in mind is that deciding on an out of the box approach today doesn’t necessarily limit your ability to customize your system’s features down the road."
Change is not easy for any organization. Automating legacy paper systems can be a real challenge. Incorporating new processes, procedures and terminology must be done carefully. Don’t underestimate the human impact factor. Sometimes selecting out of the box software facilitates procedural, policy and culture changes that a company wants or needs to make.
Finally, an important factor to keep in mind is that deciding on an out of the box approach today doesn’t necessarily limit your ability to customize your system’s features down the road. To varying degrees, most systems can be adjusted to fit your changing needs at a later date. These features can often be added once your employees have become familiar with the underlying functionality of the system.
About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and APIs with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.