Quality Control and Microbiology Laboratories in a Pharmaceutical company are frequently subject to FDA or Emea observations because of not validated excel spreadsheets, normally used to elaborate some analysis results. Unfortunately, excel spreadsheet validation is a very hard exercise, because of security, versioning and change control that cannot be properly managed using an Excel file.
Laboratory Spreadsheet Module allows to manage the excel spreasheets safely, as required by regulations.
Authorized people only can publish a new excel spreadsheet, and laboratory operators can only use only the approved version, that is "embedded", without any possibility to change any formula, chart or formatting.
All spreadsheets are maintained under change control, audit trail and version history, and can be also subject to a pre-approval process before being available to any Lab operator.
Spreadsheet approval can be managed with K2C eSignature for SharePoint , fully complying 21 CFR part 11 (Electronic Record and Signature regulation).