The GxP impact assessment is carried out to determine if the computer system has an impact on product quality, patient safety or data integrity. All GxP impact computer systems must comply with applicable regulatory requirements.
GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices, and cosmetics.
The most central aspects of GxP are Good Documentation Practices (GDP), which are expected to be ALCOA:
- Attributable: documents are attributable to an individual
- Legible: they are readable
- Contemporaneously Recorded: not dated in the past or the future, but when the documented task is completed
- Original or a True Copy
- Accurate: accurately reflecting the activity documented
- and Permanent,
The products that are the subject of the GxP are expected to be
- Traceability: the ability to reconstruct the development history of a drug or medical device.
- Accountability: the ability to resolve who has contributed what to the development and when.
GxPs require that a Quality System be established, implemented, documented, and maintained.
