The final sprint has begun: Maximum intensity in Quality Assurance.
The development of Moqlero Generation 10 is nearing completion. However, in the highly regulated pharmaceutical industry, program code is only one side of the coin. Parallel to development, our validation teams are currently working at maximum capacity on the formal verification of the system. But before we go into our current status, it is worth looking at why this process is so critical.
What do Qualification and CSV mean?
In the GMP world (Good Manufacturing Practice), it is not enough for a system to work – it must be proven that it does so consistently, reliably, and reproducibly. This proof is provided by two closely linked concepts:
- Qualification: This term primarily refers to equipment and hardware. The process follows the classic V-Model and is divided into four phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The goal is to prove that the infrastructure and devices are suitable for the intended purpose.
- Computer System Validation (CSV): CSV focuses on software and automated processes. According to GAMP 5 (Good Automated Manufacturing Practice) guidelines, it must be ensured that the software operates according to specifications, guarantees data integrity, and minimizes risks to patient safety. It is not just about testing whether the system does the right thing ("Happy Path"), but also about proving that it reacts safely in error situations.
Why is the effort so high?
Modern cleanroom monitoring systems like Moqlero are critical systems. They decide on the release of products or the rejection of entire batches. A software error that, for example, suppresses a limit alarm or corrupts data could have fatal consequences. Therefore, strict compliance with FDA 21 CFR Part 11 for reports, EU GMP incl. EU GMP Annex 1, as well as the cleanliness standards of ISO 14644, must be ensured. All data principles – summarized under the acronym ALCOA++ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) – must be technically enforced and validated.
Our Current Status: Validation at Scale
For Generation 10, we have radically expanded our validation strategy. Our team is currently executing thousands of test cases:
- Regression Tests: Automated checks ensure that new features do not impair existing functionalities.
- Stress/Load Tests: We optimize for databases with millions of records to test performance limits.
- Challenge Tests: Targeted attempts to bring the system "out of step" through incorrect inputs or connection interruptions.
- Unit Tests: Verification of the smallest software units for correct logic during development.
- End-to-End Integration Tests: Validation of the entire process chain across all interfaces.
Our Promise to You
This immense effort has a clear goal: When Moqlero Generation 10 is released, you will receive not just software, but a "Compliance Package". We deliver the complete validation documentation (Traceability Matrix, Test Protocols, Functional Specifications,...), reducing your internal validation effort to a minimum.
We continue to go full speed so that you can concentrate on your production.