The following are our IT-QMS Support services.

Log-on security for the application and spreadsheets, independent audit trail, electronic signatures, data security, and authorizations are the key implications of rule 21 CFR Part 11. Spreadsheets are often used to perform GMP related calculations trend data, Plan Calibration and qualification work and manage laboratory assets Spreadsheet developed as per regulatory compliance should be eliminated possible risk from performing GxP work to increase business efficiency and reduce regulatory risk Spreadsheets are used to collate lists of instruments and perform a multitude of calculations in many regulated laboratories. But Spreadsheets also present an auditing and inspecting opportunity to find abundant instances of non-compliance and can lead to problems and unnecessary risk.