Technology
In GxP research and manufacturing environments, the goals are simple:
- To cost effectively develop and produce medicinal products to the highest global standards;
- To fully document the above.
The latter is essential to the integrity of any product but is also the source of many current problems.
Improper documentation systems can explode into multiple layers of issues – including:
- Fines;
- Failure of "approval to produce" a drug after the research phase;
- Public audit observations;
- Loss of contract manufacturing opportunities and/or contract research opportunities;
- Bad reputation;
- Higher overhead costs;
- Motivational issues;
- Data discarding (in research);
- Closure of activities.
The root cause of quality gaps (compliance) and cost drivers can be found in the several layers of ad-hoc systems developed over time. It is possible to have great traceability control unit, great workflow processes, good document or record distribution systems, or a great document archiving department, but the root of the problem occurs in the very interaction between these work units: i.e. “how” information flows and is controlled over the value chain. SOLABS GxP adopts an integrated methodology to processing GxP information: both documents and records. It obviates the need for multiple layers of complex tracking and accountability steps synonymous with paper trails and substantially reduces the human driven steps and monitoring systems. Its end benefits include:
- Mitigation of quality risks;
- Cost reduction (can be in the region of 1%-2% of the operating budget);
- Cycle time reduction;
- Simplicity.
SOLABS GxP is one of the few GxP life-cycle document and record management systems available that has a track record, is validatable, uses high performance web-based technologies, and has a friendly, simple-to-use compliance interface.