Electronic records/signatures

Maintenance records Application software documentation Data reproduction accuracy Documented verification of process steps Operator identification Data record review by quality control Electronic record/signature type, use, control, and audit trail... 

Electronic record/signature Accuracy Repeatability Self-documentation In-built diagnostics... 

The U.S. issued specific distribution requirements in 1990 to complement the basic provisions established earlier in its GMPs. Although computer validation is not specifically identified as a requirement, separate electronic record/signature legislation (21 CFR Part 11) requires computer systems handling defined distribution records to be validated. Records should be sufficient to track the origin and destination of medicinal products primarily in support of possible customer returns and product recall. Key GDP topics identified in the U.S. legislation that validation should address in relation to computer systems include ... 

Use of Electronic Records/Signatures Confirm whether or not the software falls within the scope of the Electronic Records and Electronic Signatures Rule, and if so that the required functionality (where appropriate) has been provided. 

Validation Determination X X X X May initiate a detailed electronic record/signature... 

Electronic systems used to manage calibration should fulfill appropriate electronic record/signature requirements. 

While compliance with electronic record/signature regulatory requirements is not without its challenges for new systems, they are small in comparison with those involved in bringing legacy systems into compliance. 

Regulatory authorities expect electronic record/signature requirements to be addressed although some leniency may be given to older legacy systems. Shared regulatory expectations include ... 

Drawing up a timetable indicating how and when compliance with electronic record/signature requirements will be achieved in a company... 

The lack of validation or incomplete validation was the next most common observation. The need for prospective validation of electronic record/signature capability during computer system implementation is stressed in two of the six Warning Letters, making an observation on validation. The compnter systems concerned were Computer Aided Drawing, Process Control Systems, Record Keeping Systems, and EDMS. 

Three of the Warning Letters referred to a wider organizational review of electronic record/signature requirements beyond the scope of the particular computer systems that were the focus of the original inspection. Pharmaceutical and healthcare companies should ensure that they have a compliance plan that covers the whole part of their organization subject to 21 CFR Part 11. 

Appendix 16D Electronic Record/Signature Inspection Checklist.410... 

The ISPE has published two important concept papers for functional risk management and electronic record/signature risk management." - These papers mark the start of what is likely to become a new era in applying risk management as an integral part of computer system validation. 

Electronic records/signatures — assessments and follow-up plans... 

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