Generates Alarms for different machine controls i.e. Over under Temperature, Low air
pressure, NFD bypass, foils joints ( optional ). Emergency stop, VFD faults etc.
Easy to edit all parameters, as entire operation is controlled from single PLC.
User interface through touch screen HMI.
Three level password protection.
Tower lamp for showing machine status
21 CFR COMPLIANCE DETAILS:
The system works under below compliances:-
1. Access Management:
Password-protected individual user accounts.
Password and User ID policy (Individual unique ID and Password, minimum length and strength of User ID and Password).
Automatically limit number of failed login attempts.
Automatically record unauthorized login attempts.
System shall ask to change the password to user periodically (at settable interval of time) by giving prior notification on each logging. Time for prior notification shall be settable at customer end.
Automatically password protects HMI systems when idle for short periods. (Auto log-off facility & auto log-off time is settable at Admin level in HMI.
2. User management system & Privileges
The user rights are defined at all user level as per Customer requirements at development time only.
User Rights cannot be defined for Individual user/person. Individual user automatically gets rights as per his level.
User level can be change in to Admin level in HMI.
Access levels as Operator, Supervisor, and Administrator. Configurable user access rights at admin level. (Any user can be move to any level for example: if user' A' is Operator after few days Admin can change his level as Supervisor then user 'A' will automatically gets Supervisor Rights).
Read only Access to Unauthorized user (system should prevent the delete, copy, paste, etc. operation from unauthorized user).
3. Electronic Data
Save all batch records, reports data in human readable form and suitable for inspection and review.
Generated data shall not be edited or altered. (Data archive format should be non-editable).
Facility to store data in files/folder to alternate location at authorized user level.
4. Audit Trail
System should track all Creations, Modifications, and Deletions performed in the system. All activity should be logged between login and log out with time and date along with user details.
All critical hardware related errors and warning should be logged in audit trail. (E.g.: Low disk space, Communication fail, power fail, etc.)
Time & date should be synchronize with local time and should not be editable through unauthorized user.
System shall prevent to modify or delete audit trail.
Audit trail records can save in Customer PC it as long as possible depending on space available on its Hard disk.
5. System & Data Backup
Software shall have facility for auto data back-up to customer PC or connected central server. Separate path should be provided for Back-up in HMI at admin level. Auto back-up should be in "Time Series".
User shall not be able to save or relocate the data/result files; it should be controlled through software only.
Date format should be DD/MM/YY & time format 24hours i.e HH:MM:SS. (Time should be as per Indian Standard Time Zone i.e GMT+5.30 Hrs
Software shall have facility to generate Batch report, Audit trail report & Alarm report.