Establishing and depending on a quality system is vital for any facility to ensure Good Manufacturing Practices (GMP) compliance. Without an accurate quality system in place, the risk of error that results in non-compliance is not only significantly increased – it’s practically assured.
To help organizations maintain GMP compliance, our team included a Quality Management System (QMS) in our InstantGMP™ PRO software. Completely integrated in our all-in-one solution, this QMS provides quality assurance groups with greater visibility, improved traceability, and improved workflow processes. Best of all, it allows anyone managing quality in a GMP environment to be audit-ready – without the need of paper.
Before we demonstrate the ways our integrated QMS helps reduce the quality burden for manufacturers, we would like to discuss the drawbacks of using multiple, non-integrated systems to manage quality assurance.
The Disadvantages of Multiple Systems
When the GMP manufacturing industry evolved from paper-based systems to electronic systems, it made day-to-day processes more efficient. By using various electronic manufacturing, inventory and quality assurance software systems, facilities no longer have to rely on writing and recording processes in physical documents.
Although these various pieces of software are a step in the right direction for improving manufacturing processes, they also present several major drawbacks. In addition to being expensive, each individual piece of software requires a great deal of time to validate and implement. However, the biggest drawback is the fact that these various software solutions are incompatible.
This incompatibility places an enormous burden on quality assurance groups. For example, every time there is a deviation, the QA team must manually transcribe the information from the Batch Production Record (BPR) software and upload it to the quality system software. After that, all of the pieces required to perform the corrective action must be manually recorded in the separate inventory system. Then all of the various information must be entered into the training system.
Having to manually transcribe all of this various information into separate, incompatible electronic systems is detrimental to workflow processes in multiple ways. First, it’s incredibly time consuming. Instead of being more efficient, QA teams are spending more time manually updating multiple systems. This practice can also cause further delays in processes as the QA specialists have to track down all of various pieces of information from multiple operators. Perhaps the biggest disadvantages of using multiple systems is the fact that the risks of redundancy and transcribing errors are elevated.
While using multiple software systems to maintain GMP compliance is incredibly inefficient and problematic, it doesn’t mean that manufacturers should not rely on an electronic system. They just need to rely on the industry’s most innovative all-in-one software solution: InstantGMP™ PRO.
The Advantages of All-In-One Software
InstantGMP™ PRO all-in-one software relieves the quality burden by allowing facilities to manage their total quality without ever having to leave the system. With its fully integrated Quality Management System (QMS) that is connected to every part of the system, our all-in-one solution makes maintaining GMP compliance more efficient, effective and accurate.
Now, if something out of spec occurs during the manufacturing process, an operator can easily create a BPR deviation that is automatically recorded in the Deviation Log. Thanks to the integrated QMS, the Deviation Log is connected to a Corrective and Preventive Action (CAPA) Log.
Using the CAPA Log, operators can record and perform the necessary corrective action. Once this action is completed, all of the information related to this action is automatically updated in the Training Log so that all operators can be trained on this new process moving forward.
To maintain continued GMP compliance, operators cannot access the new updated BPR until they have been properly trained on the new procedures and processes.
By integrating a QMS in our all-in-one software, InstantGMP creates a continuum that improves workflow processes and makes quality assurance more efficient, effective and accurate. This ensures that a facility maintains its GMP compliance without having to rely on multiple, incompatible systems.
If your organization is interested in moving beyond multiple electronic systems and implementing an all-in-one solution, InstantGMP is ready to help you take action.