How the result is transmitted to the system is the most critical aspect of data integrity. Every transfer from device to paper, from paper to table, and from table to system generates an error and a question mark.
Scope
Direct device connection: Direct acquisition of data from devices such as balances, pH meters, chromatographs, and spectrophotometers; elimination of manual entry.
File-based transfer: Transferring output files generated by the device firmware to the system using defined templates.
Automatic calculation: Calculating the final result from raw data using a formula defined in the method; recording inputs such as dilution factor, weighing, and moisture correction into the system.
Instant specification assessment: The result is marked as suitable/unsuitable/out of trend at the moment it is entered.
Input checks: The system performs checks for decimal accuracy, unit, reasonable range, and difference between repetitions.
Approval hierarchy: Analyst input, verification, and final approval steps are carried out using electronic signatures.
Preservation of raw data: Ensuring that the raw data and chromatogram underlying the final result remain accessible.
Why is manual entry a risk?
The most frequently questioned aspect of audits is how the result is transferred from the device to the system. If there's a manually entered step in between, the auditor asks: "How do you prove that this number is the one generated by the device?" If the answer is a signed document, the proof is weak; if the answer is a record from the device protected by an audit trail, the proof is strong.