Modularization and Audit Security
In strictly regulated GxP environments, documentation is the foundation of compliance. A key achievement in Moqlero is the advanced modularization of the documentation landscape. This optimized structure eliminates redundancies and maximizes auditability.
Proven Core Concepts
The structure is based on the proven V-model of software validation. By clearly categorizing functional requirements, design specifications, and test protocols, auditors can view the required evidence in a targeted manner. Another essential component of the documentation strategy is Lifecycle Documents. These accompany system elements (such as particle counters or cleanrooms) throughout their entire lifespan. Changes, calibrations, and qualifications are updated chronologically and seamlessly within these documents, ensuring the history of each element remains traceable at all times.
Audit Support
Thanks to advanced modularization and the aggregated presentation within the respective Lifecycle Documents, a consolidated information base is provided. This facilitates data integrity checks and supports an efficient review process.