Metasys® for Validated Environments (MVE ... - Johnson Controls

Traceable Electronic RecordsElectronic records are more efficient and easier tokeep than manual records, but most electronicrecords can be easily altered. Therefore, the FDArequires all electronic means of record keepingincorporate traceable electronic signatures and beavailable only to authorized users. The use ofAdobe® Acrobat® software and the MVE systemauthenticates electronic signatures to validatedocument review. Microsoft SQL C2 Security tracesdatabase alterations. These features preserve theintegrity of the data and simplify Part 11 validation.Figure 10 shows an example of a Mean KineticTemperature report for a typical product storage cabinet.In this case, readings are collected from three differentareas of the cabinet in addition to a single humiditysample. Each location provides a minimum, maximumand average reading. The Mean Kinetic Temperature isalso indicated for the selected sample period. Once theresearcher reviews the report for accuracy, she appliesher electronic signature that is then affixed to the report.Anyone who receives the report electronically can clickon the signature for verification of authenticity. Anyonewho attempts to modify this report once signed nullifiesthe signature, and the report identifies the document wasaltered after signing.Extensive Subsystem Integration LibraryThrough the Metasys Compatibility Program,Johnson Controls has developed the world’s largestlibrary of software drivers to integrate third-partydevices and subsystems. From air handlers andchillers to Programmable Logic Controllers (PLCs),particle counters and other vendor BuildingAutomation Systems (BASs), integrated devicesseamlessly become part of the MVE system and aregranted the same data security and electronictraceability features for Part 11 as native Metasyscomponents.Figure 10: Status Report with Electronic SignatureMetasys for Validated Environments (MVE) Product Bulletin 9