GxP is an acronym referring to good practice. It entails regulations and guidelines that apply to life sciences organizations that make food and medical products (drugs and medical devices and medical software applications). These regulatory bodies include the Food and Drug Administration (FDA), World Health Organization (WHO), and the European Medicine Agency, among others.
Cloud computing, on the other hand, is a model that enables on-demand network access for computing resources. The information can then be rapidly accessed and released with minimal effort. Google Cloud offers a wide range of services, from smart analytics to artificial intelligence.
Here are some of the google requirements that ensure GxP cloud compliance;
Ready retrieval is a term associated with having a reliable backup and restore process or high availability systems. GxP cloud compliance documents and data storage systems should protect and retain records as well as enable their accurate retrieval. Storing one’s data on cloud enables tailored recovery of documentation at any point from anywhere across the globe with a reliable backup being included.
Customers can also provide services such as bigquer. They allow the organization to set an expiration for certain types of data in line with their data retention policies. That reduces the need for users who need to access and delete or preserve data manually.
Only a small group of Google employees have access to data. Cases, where google might access GxP cloud data, is in cases where the data is necessary for fulfilling legal obligations. Google allows its customers to have near real-time logs when google employees access their content. That is proof that the information belongs solely to the GxP systems.
Only approved employees with specific roles can access data storage centers. That is made sure by having perimeter fences, metal detectors, biometrics, alarms, and custom-designed electronic cards. These measures enhance the safety of an organization’s data.
Identity and Access Management
GxP cloud compliance systems require governing who can access data regularly. That prevents the risk of data deletion or alteration of records. The right to access should be granted per the organizations’ appointment as well as the job position. This ensures that the GxP team can access any information they require so long as it is within their job responsibility.
Cloud access management lets the administrative delegate take action on specific resources. That provides full control and visibility to manage data centrally.
Data Security and Audit Chain
Aside from data maintenance requirements, GxP cloud records should also be protected from unauthorized alteration and deletion. The organization should know the time of data creation, who created the data, who has accessed the data, and if any changes were made. That is made possible by a reliable audit trail that shows the previous result, the new findings, who made the changes, specific time, and official date stamp. This way, changes made are easily detectable.
Gxp system data is termed as being sensitive. Therefore google provides a variety of security products that protect and manage the organizations of data. Google advises that clients scan their work frequently to detect common problems.
Gxp organizations can take advantage of google cloud products to streamline product development with compliance with FDA and other regulatory organizations.