Software & Documentation
Installation Qualification (IQ)
To confirm that all equipments are installed as per specifications and having proper model and serial numbers mention on equipments and on documents.
Operational Qualification (OQ)
It verifies control operation features with alarm, software features, safety features etc.
Performance Qualification (PQ)
It defines that equipment is working within its operating range as per specification.
Design Qualification
It defines the detail design and specification of Equipment.
Software Features (21 CFR Compliance - Part-11)
- MKT (Mean Kinetic Temperature).
- Secured audit trail (User, Equipment, Alarm, Events).
- E Records and E-Signatures with Date and Time.
- Log data, Events and Audit trail data recording.
- Auto back up facility.
- Data generated on PDF format.
- All the alarm, door open etc event logged with reason matter.
- Password Encryption.
- Authorized multilevel Username and Password.
- Real time analysis and Graphical Analysis.