Less effort. Less headache. More time doing science.
When it comes to GxP compliance, this is a must for biopharma. And in a previous blog, we discussed how you can make compliance easier. However, choosing a new technology to help handle your scientific data and streamline compliance isn’t straightforward. Data, hardware, software, and GxP standards are constantly changing. Service providers need future-proof processes that will ensure GxP-compliant environments today and tomorrow. This means that biopharma leaders need to check whether providers are structuring their internal development processes appropriately.
What should I be looking for?
Consistent, reliable compliance practices across an organization facilitate the traceability, accountability, and data integrity required for optimized GxP processes. Biopharmas need to ensure that service providers are utilizing structured processes and operating within a culture of compliance.
Below, you’ll find what is required of providers to develop robust, dependable, and compliant scientific data solutions.
The four pillars of GxP compliant software development
- An ISO 9001 certified quality management system (QMS).
A QMS ensures that an organization can safely contain, hold, and manage data that is intended for GxP use downstream.
- A software development life cycle designed with compliance in mind.
Rigorous adherence to compliant business operations ensures that software development is completed both appropriately and ethically. This enables organizations to build standardized and consistent services such as user requirements, testing, regression suites, and downstream control.
- A verification suite.
These tests determine if a product is “fit for purpose.” Suites should include functional and unit tests to determine if individual features of the software operate appropriately and whether there are any gaps or bugs. Then, regression tests should be used to figure out if existing features will function appropriately when new features are built into the system.
- End-to-end use case testing.
“Fit for use” testing analyzes real-world usage of data (ingestion, transfer, harmonization, analysis in downstream application, etc.) by running data through simulations of field usage. This ensures key GxP aspects like traceability, accountability, and data integrity are maintained through typical data lifecycles. By doing so, errors can be caught, problems diagnosed, and solutions tested in zero-risk environments until programs are completely validated for compliance with GxP standards.
Simplify your GxP compliance processes
The Tetra Scientific Data Cloud™ is the industry’s only scientific data cloud. It helps biopharmas reduce compliance efforts and costs, improve productivity, and accelerate and improve scientific decision making. It connects, collects, engineers, and enriches scientific data across R&D, manufacturing, and QA/QC. It is purpose-built for scientific data and designed with compliance in mind.
Our QMS, software development cycles, and verification/validation suites are built by people who understand biopharma, GxP, and the scientific data challenges biopharmas face.
Just listen to TetraScience’s Dr. Mike Tarselli. In this short video, he discusses how TetraScience approaches quality and compliance, helping customers' scientific data “fly”.
Looking for more info on TetraScience’s GxP offering? Visit our website