Summary:

Stability Automation Application Software consistently meets the criteria of FDA 21 CFR Part 11 throughout all its modules. FDA 21 CFR 11 stipulates that all electronic data must correspond to particular requirements, in order to ensure comprehensive documentation of all processes that is secure from manipulation. A significant element in FDA 21 CFR Part 11 compatible projects is, therefore, the audit trail.

Solution:

The system is constructed is based on the following points to comply with the FDA 21 CFR Part 11 regulations:

User Management Functionalities:
Password protected individual
Multiple User Level as per the User Rights.
Password Validity.
User Block/Unblock Facility.
Configurable Number of Wrong Attempt.
Minimum 8 Character password length.
Password Complexity.
Unique user account.
Audit Trial:
Tamperproof and Non-Editable Audit Trail Data Format.
The time stamp of the change of the parameter value and user making the change.
The audit trail records following details:
User Creation
User Login / Logout
Wrong attempts of login
User Block / Unblock by Administrator
Old value and new value of parameter change.
The timestamp of each event.
System Data Backup: HMI offers basic connectivity for data exchange with Central SCADA / MES / ERP by following means:
Through HTTPS and OPC Protocol
Through FTP and OPC Protocol
Electronic Data Record and Data storage:
Review of the reports on the HMI Screen for Production, Alarms and Audit Trail.
Storage limit can be interlocked in terms of the number of batches produced or % of the memory consumed.
Report Generation and Printing:
​​​​​​​Batch data is stored in secured database format and Batch Report can be generated using this data.
Report Printing
Case 1: By Using FTP and OPC Protocol:

FTP: File transfer protocol(FTP) is a way to connect two computers to one another in the safest possible way to help transfer files between two or more points.

Using FTP Server files are either uploaded or downloaded to the FTP server. When you’re uploading files, the files are transferred from a personal computer to the server. When you’re downloaded files, the files are transferred from the server to your personal computer.

OPC: OPC is implemented in server/client pairs. The OPC server is a software program that converts the hardware communication protocol used by a PLC into the OPC protocol. The OPC client software is any program that needs to connect to the hardware, such as an HMI. The OPC client uses the OPC server to get data from or send commands to the hardware.

Application Software developed using LabVIEW and Communicated with Beijer HMI over FTP Server and OPC Communication to read and write data for Stability Chamber system, this application allow user to get different variants of Beijer HMI models, Alarms, Proces Parameters, Batch result & Audit trails can be viewed on screen with filtering options.

Case 2: By Using HTTP and OPC Protocol:

HTTP: Basically, HTTP(Hyper Text Transfer Protocol) is a TCP/IP based communication protocol, that is used to deliver data (HTML files, image files, query results, etc.) on the World Wide Web. It provides a standardized way for computers to communicate with each other. HTTP specification specifies how clients’ request data will be constructed and sent to the server, and how the servers respond to these requests.

Application Software developed using LabVIEW and Communicated with Beijer HMI over HTTP and OPC Communication to read and write data for Audit Trails and Batch reports, this application allow user to get different variants of Beijer HMI models, Batch result & Audit trails can be viewed on screen with filtering options.