Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been
at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments
of the medical device and pharmaceutical industries.
From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel member not familiar with computer
systems validation activities. Specific to these challenges are the validation of electronic spreadsheets or
forms.
Spread sheets.pdf (229.5 KB)
Excelente aporte
[quote=gokeeffe]Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been
at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments
of the medical device and pharmaceutical industries.
From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel member not familiar with computer
systems validation activities. Specific to these challenges are the validation of electronic spreadsheets or
forms.[/quote]