21 CFR Part II Compliance
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PRODIGY DELIVERS THE COMPLIANCE TOOLS YOU NEED In 1997, the FDA issued regulations originally designed to qualify the electronic submission of data. These regulations were designed to provide criteria for acceptance of electronic records as equivalent to paper records. Since that time the scope of the regulation has expanded to include most instruments that can maintain an electronic record of results. Similarly, the EPA has introduced CHROMERR (Cross- Media Electronic Reporting and Record keeping Rule) into environmental analyses. User Login Administration Site Name: |demo Authorizedpersonnel (other than the system administrator) may access the "User Login Administration" panel only to change their password. 21 CFR part 11 requires that the instruments employed be able to track the active operators, control their access to sensitive operations and record their Prodigy satisfies this requirement by demanding the active operators log into the software with a valid password before any further action is permitted. Further, the system administrator alone has the authority to add new users, de-activate obsolete users, and assign specified user permission levels. The log-in icon is available at all times after successful login and allows easy transition between active operators. Audit Trail lO-OTtE HodtmNtmi METHOD >M-rr '< r~-.r.-)l' lUXta HnlnNnr MrlHiin AnJFnJ^l™ lillhri riidnU*™ MFThrHD hdhrfi^in H22J5 HodfwNmn METHOD v.yf-g..- WNK HrcKwNmt METHOD <4tJ FWiyLna ■«;.■.'-■:■ HodtoiHtfM ML1HJD A^PHtiqlM Recent changes are identified with asterisks for easy recognition. All actions and instrument conditions must be recorded in an audit trail. Prodigy offers an audit trail sorted by • Once a method name is selected, all of the analyses for that method appear • Highlighting an analysis block (see highlight to left) displays a snapshot of all of the method parameters active • Subsequently, selecting an analytical line reveals all of the information for the data acquired at that line.

Calculation Validation Results | Scans 1 Profiles Calc Validation | Image | Ctrl Chrt | Report | Line |jiffl||j|i|§ff|j Print || 21 CFR part 11 requires that the ability to regenerate reported data Prodigy software offers a Calculation Validation display for every analytical • This display shows the raw data for each analytical wavelength. • The peak and background locations. • Peak and background intensities. • Background correction. 21 CFR part 11 requires that Prodigy automatically saves the results for every analytical • Each measurement name is added to an analysis tree which •...