Electronic Data: Audit trails are activated on all electronic data generated by DataChem (DCL). Audit trails contain records of when and what was done to the electronic file.

DataChem Policy:    Extreme caution is required when using manual integration, particularly when the integration affects method compliance. Each manual integration must be documented in the data package and the technical justification provided.

Quality Assurance personnel will examine chromatographic data during internal method audits to determine compliance with the procedures.