GxP QMS SYSTEM SETUP
What is GxP in the life sciences industry? Breaking down the term, the letters G and P stand for good and practices respectively, while the letter x represents a variable part of the drug or medical device manufacturing process. In the life sciences industry, the x commonly stands for manufacturing (GMP), clinical (GCP) or laboratory (GLP), though there are other steps of the production lifecycle that are all significant in their own framework such as storage (GSP), distribution (GDP), etc.
It is crucial to have a complete and detailed hold of GxP compliance standards for an organization to be successful as failing to meet GxP standards could be financially and otherwise damaging. While it might be overwhelming to try to go through every FDA regulation, the right software can help you streamline the process by identifying and listing regulations, storing documents to prove these regulations were followed, establish guidelines for following them, and offer easy access to all records for audits.
5 benefits to implementing a GxP quality management system (QSM) software:
1. Achieve a smooth workflow
Using a GxP QMS software allows organizations to interlink all quality processes to offer the most complete overview of their processes and compliance status. Full traceability of actions, storage and quick access of files, ability to set automatic notifications for tasks, training, calibration are a few of the many benefits of implementing a GxP QMS software.
2. Improved training management
A GxP QMS software would not only compile all compliance requirements and documents in one place but also allow organizations to manage training guides, notify teams and team members of training updates, and keep track of training progress.
3. Govern document access and track the use of e-signatures
Organizations can ensure only the correct people have access to necessary documents using a GxP QMS software through sending timely notifications when there are updates and changes to be approved. In addition to managing access, organizations can also trace and manage the use of e-signatures in order to maintain FDA 21 CFR Part 11 regulations.
4. Efficiently manage CAPA
A GxP QMS software can keep track of CAPA and document all corrective and preventative actions taken on a case. Organizations can use this feature to identify quality issues and patterns. They can also track due dates and observe employee performances on each case.
5. Faster and more effortless audits overall
Streamlining the regulation process and making it a standard practice to compile all information using a GxP QMS software would ultimately result in a shorter audit-prep process, reduced possibility of errors, and a smoother and more efficient audit process overall.
Contact Precision Life Sciences if you would like help with a GxP QMS implementation.