What are the FDA requirements for software to comply with GxP guidelines?
To comply with GLP guidelines, the FDA requirements for software are:
- System access must be limited to authorized individuals.
- Operational system checks (verification) must be performed routinely and authority and device checks must be implemented.
- Electronic signatures must be used, and signatures must be audit-trailed.
- All records must be date and time stamped.
- Sequencing of events must be adequately documented (i.e. audit trail), and changes to records must not obscure previous entries (raw data must be preserved).
- Copies of electronic records must be available in common, portable formats (such as PDF) so an FDA investigator may have reasonable and useful access for validation.
Although our software addresses regulatory requirements, each scientist and their company is responsible for following the requirements and determining which regulations and requirements apply to their particular situation.
- People who develop/maintain/use electronic systems should be provided with appropriate training in order to perform their tasks.
- Written policies should be established and adhered to, thereby holding individuals accountable for their actions while using electronic records and electronic signatures.
- There must be appropriate control over systems documentation.