Regulatory Compliance with Microsoft® Excel®
Microsoft® Excel® offers rich functionality to meet requirements of a modern pharmaceutical laboratory, be it calculations, releasing a COA, maintaining on line data book or keeping any other information. However lack of regulatory compliance severely limits the use of Excel®. LabHawk envelops Excel® with a security shell and enables to meet 21 CFR part 11 and other regulatory requirements.
- Modification History / Audit Trail to record all changes made to Excel® files with time stamp, user ID, old and new values and user comments. File version no. is increased for every save with changes.
- Electronic Signatures for online submission, review and approval of Excel® files
- Controlled issue of templates with easy tracking by unique issue no.
- Extensive user management helps configure software as required. Password and other policies can be set to individual needs.
- Complete data security with encryption, controlled user access and disabeling of "Save As" from Excel®. Watermarks on printout to identify status of the file.
- Uses data base to store all information of files. Allows easy search of data. Convenient Windows like tree strucure to organize data as required.
- Web based software deployed on intranet with thin client on individual PCs.
- Installed and commissioned in a matter of days, existing Excel® templates easily imported.