Siemens The APOGEE Compliance Solution with Desigo CC— Technological Elements for 21 CFR Part 11 Compliance, Specification Sheet

Specification Sheet No A6V11273349 2021 APOGEE Compliance Solution with CC Technological Elements for 21 Part 11 Compliance U S FDA 21 CFR Part 11 was developed to the widest possible use of electronic technology support of electronic record and electronic signature While the use of electronic records is an industry trend to move to paperless is driven by the efficiencies of electronic media the increased reliability and data integrity potential electronic systems over manual processes The rule first issued in the spring of 1997 In 1998 the Technologies Division of Siemens Industry delivered the first APOGEE Compliance Solution to address compliance needs The APOGEE Solution continues to evolve and with revision provides users increased operational as well as a reduction in risk APOGEE Compliance Solution is a combination of and procedural elements designed to full compliance with 21 CFR Part 11 see 1 while minimizing the risk of failure procedural elements include system validation standard operating procedures and migration performed by the system installer technology portion of the solution includes the features of Desigo CC software and field firmware The technological elements necessary meet the requirements include record security retention audit trails system security and checks guiding principle of the compliance solution is to increase efficiency and reduce risk by the most effective mix of services and available at any point in time 1 The APOGEE Compliance Solution Records term electronic records can be applied to data many types of systems and applications Within APOGEE Automation System there are six types records generated by the system that can be critical compliance Trended Value Records Alarm Records System Activity Log Records Audit Trails System Configuration Parameters Custom Programs System Graphics APOGEE Compliance Solution addresses each throughout its lifecycle including the point of transfer through the APOGEE Automation to long term lifecycle management and The compliance solution consists of a series components and procedures working together The of any one of these significantly increases the of non compliance Industry Inc 1 of 5 and Digital Signatures Enhanced Logging and Audit Trails The information is automatically recorded in Desigo CC History Database when a object is modified or deleted Property Describes what part of an object changed Previous Value Displays the value of an property before the change deletion Value Displays the value of an property after the change deletion Comment Displays why a change to or of an object was made or more as to why an action was User Displays the user account that the change to or deletion of an Object Version Displays the current version the object CC Assisted Treatment Assisted Treatment feature for Desigo CC a structured process to manage the life cycle an alarm issue from initiation to resolution Assisted operating procedures enforce an ordered process that must be followed for each in alarm The individual steps can include alarm printout view predefined view graphic contents run reports and or operator actions the functionality of the Notification extension for alarm notification and Desigo CC long term for data management compliments Assisted as a critical alarm management application regulated facilities Desigo CC solution provides a robust data platform to secure and maintain specific records over their useful life It is not simply archiving or backup utility but an active data system supporting secure access to data providing the foundation and tools to convert data useful information The Desigo CC solution provides horsepower for supporting long term data needs in addition to effectively managing building systems Signatures refer to the digital representation a signature that is used to authorize or reports This functionality is reserved for authorization of compliance level reporting Signatures which often refer to the use of such as User ID password to track changes or access to system functions are used the APOGEE Compliance Solution but not be confused with electronic signatures As example inserting an electronic signature into a may require a digital signature Compliance Solution Elements technological elements of the APOGEE Solution represent the combined features application of the field panel firmware and Desigo workstation software While either can be to be compliant within its range of both must be implemented to ensure the comprehensive and effective compliance CC CC provides functionality for detailed tracking modifications and deletions of selected objects With CC you can track which property of an object changed its value before and after the change the change was made who authorized the and from where the change was made Desigo uses the concept of a validation profile to allow the the ability to identify which components of the receive enhanced logging Validation Profile Modifications and deletions to object that has the profile enabled will require a from the user and may require a user optional to execute the modification or Depending on how the object is set up attempting to modify or delete the object will required to enter a comment and be allowed to or enter a comment and be required to their user password to continue Any or deletion to a designated Object the user to enter in a reason for change is permanently attached to the electronic objects have revision numbers that are maintained by the Desigo CC Any editing of a designated object increments the revision number numbers may be used to track changes objects as an alternative or supplement to paper records The revision number is in the Log Viewer in the Desigo CC 2 of 5 Industry Inc CFR Part 11 Designed Features Archive Management Desigo CC provides key features of the Desigo CC solution that are to support 21 CFR Part 11 compliance Management of Electronic Records Desigo software provides long term management and of key electronic records These include records alarm records system activity and Assisted Treatment operating records Audit Trails The Desigo CC software provides audit trails on data within the Desigo CC and automatically records critical to records in the history database This the Desigo CC database the central place reviewing all audit trail information Security Desigo CC software uses multi integrated Windows security to ensure the right people have access to the right ensuring necessary record access to key stakeholders Direct Interface to History Database provides direct secure and reliable data exchange between the Desigo CC application and history database This interface reduces time and provides increased in the transmission of data to the long data management solution without having to logged at an intermediate location Advanced Electronic Records Processing and Desigo CC applications provide a range of report and processing tools to turn into information These include Alarm Summary Table with Chart Report detailed alarm event totaling total alarm time in tabular and summaries Summary Statistics Table with MKT Report designed to show key statistical including MKT Scatter Chart Repo