This former year and the global disturbance have brought out how life science associations need to embrace the industry 4.0. The industries are modernizing their technology through moving to the cloud to have a much more secured, productive operation and useful infrastructure to support the clinical and research activities. As the enactment of cloud technology commences, it is now important for you to join your associates to understand the boundaries of cloud adoption and GxP cloud compliance.
What is GxP?
GxP is an acronym that illustrates the guidelines and regulations applicable to the life sciences associations that produce food and medical commodities such as drugs, medical software applications, and medical devices. The overall objective of GxP regulations is to ensure that medical products and food are safe for customers and to maintain the integrity of data used to formulate product-related safety decisions.
The term GxP comprises a wide range of compliance-related activities such as Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), etc., they all have product-specific regulations that life sciences associations must execute based on:
- Type of commodities they make.
- Country where their products are retailed.
The 5 P’s of GxP cloud compliance
GxPs are designed to be based on identical requirements and principles. There are a lot of similarities in the GxP meanings among the regulations and guidelines that can be abstracted as 5 P’s:
Employees must know their duties, be perfectly trained for them, and follow all the procedures.
Procedures must be clearly documented and followed. Any variations must be recorded and investigated.
Specifications should be understable, documented and followed. Standard procedures for testing, labeling and packaging should be used.
Facilities and the equipment should meet regulatory criteria. The supervision for cleanliness and preventing cross contamination must be there.
Processes must be clearly defined and documented. The change control protocols need to be active and documented.
What is the difference between GxP and non-GxP?
Non-GxP mainly refers to something that is not designed with compliance in the first place, or is not compliant. For instance, a software system which is not developed for the regulated industries, then it would be contemplated as non-GxP.
Characteristics of good GxP Software
- Document Control
None GxP compliance software is complete without featuring a good document control. The document control feature should automate routings, follow-ups, escalation and authorization of documents.
- Training Management
Under GxPs, staff must be properly trained and firms must record the training process. Training management system should be capable of sending out training tasks and recording training automatically.
- Corrective and Preventive Action (CAPA)
The CAPA process is complicated to deal with, without a GxP software. The software should let you start a CAPA form of any type of form, such as complaints. This feature will minimize data entry issues and human error.
- Audit Management
GxP software does not do much good if you can not effortlessly show an auditor what you are working on. Working with some best audit management tools can simplify audits and all the related tasks.
It is crucial to follow the GxP guidelines for quality control. This ensures a product is safe and is meeting its intended use, especially for regulated industries including medical devices, drugs, foods, and cosmetics.