Electronic forms in a GxP environment
Electronic forms play an essential role in the GxP environment. They make processes in regulated industries such as pharmaceuticals, biotechnology, and medical technology more efficient, transparent, and traceable. This is particularly important to ensure compliance with GxP regulations and safeguard product quality, safety, and efficacy.
Electronic forms enable deviations to be systematically recorded, the underlying causes to be identified, and corrective measures to be planned and implemented as part of the CAPA (Corrective and Preventive Actions) process. These steps can be efficiently documented and monitored using electronic forms, improving the CAPA process’s traceability and transparency.
Electronic forms enable standardised recording and evaluation of deviations from specified requirements or procedures. This allows deviations to be systematically analysed and documented, and appropriate corrective and preventive action can be taken.
Electronic forms enable structured management of changes to processes, documents or systems in the change process. They facilitate the recording and evaluation of change requests and the tracking and approval of changes by different levels of the organisation.
Overall, electronic forms in the GxP environment help improve compliance, increase process efficiency, and strengthen quality assurance by ensuring precise documentation, traceability, and transparency in essential processes.
