Spreadsheet Development And Validation
Regulated industries use Spreadsheets for data manipulation, data storage, and data reporting. The possible applications of electronic spreadsheets include automating analytical data calculations from various laboratory analyses, tracking and summarizing product complaints, and gathering and summarizing clinical trial data collection and analysis.
As per the FDA, four key drivers against which the systems must be evaluated are authenticity, data and system integrity, confidentiality and non repudiation. The validation effort poses a significant challenges primarily because of the capabilities of the modern electronic spreadsheets; for example: excel spreadsheets with automated reporting and data manipulation and presentation through the use of forms, macros, modules driven by high-level programming language such as VBA.
Regulogix provides spreadsheet development and validation services along with the documented evidence of their correct functionality.
The process is designed to maximize efficiency and focuses on repeatability of the usage of the spreadsheets and helps its customers complete confidence in your spreadsheets outputs both for regulatory compliance (21 CFR Part 11) and operational accuracy.
(As per the requirements of 21 CFR Part 211 (211.68(i), 820 (820.70(i))
Based on the standards of ORA’s (Office of Regulatory Affairs) Laboratory Manual Section 4 Basic Statistics and Presentation Volume III - 4.5 Development and Validation of Spreadsheets for Calculation of Data