• auditaadvanceequipment@gmail.com, info.auditaa@gmail.com
  • +91 93709 65719

CFR Part 11 Complice Software

  • Software developed based on 21 CFR Part 11 Compliance
  • Reports Includes: Temperature & Rh master data & Scanner Data Report, Graph Reports, Machine Alarm Reports, Machine Audit Reports, Software Audit Reports, MKT Reports in Non Editable Pdf Format
  • Electronic Signature
  • Password Complexity & Expiry, and Block User if more than 3 wrong password attempts
  • Connectivity: Ethernet LAN Cable, can be connected to any PC to Machine within same Network
  • User Management, access based on Level
  • Offline Record can stored upto 1 lakh records, and Downloads within 1 mins
  • Multiple Chamber Connectivity Option
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Data Logger

Data Logging :

  • Temperature & RH data record are stored in Memory with Date & Time Stamp.
  • Upto 1 Lakh Record can be saved in Internal Memory respectively.
  • Scanner Data will also be recorded if Scanner is available.
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Alarm Logging :

  • Temperature & RH data record are stored in Memory with Date & Time Stamp.
  • Upto 1 Lakh Record can be saved in Internal Memory respectively.
  • Scanner Data will also be recorded if Scanner is available.

Audit Logging :

  • User Operation will be recorded & stored in Memory with Date & Time Stamp.
  • Upto 1 Lakh Record can be saved in Internal Memory respectively.
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Printer :

  • If Printer is Connected, Direct Online Data

Software Salient Features :

  • Our Software comply the 21 CFR Part 11 guidelines set by the FDA (Food and Drug Administration), mainly Recoding Electronic Record and Signature which are considered Equivalent to Paper Records and Handwritten Signatures.
  • Our Software is an Advance PLC HMI base Software
  • Our Software is designed to Control and Monitor Parameters of the Equipments Provided by Our Software ADVANCE EQUIPMENT.
  • Our Software is designed to Monitor Parameters of the Equipments from any PC within the Server of the Pharmaceutical or Scientific Organization assigned by the Organization.
  • Our Software has the following function
  • One Software connects multiple equipment of different Departments irrespective of Equipment's locations.
  • High Speed Ethernet Connectivity
  • User friendly UI.
  • Multiple User Group Creation.
  • Multiple User Creation assigned with specific user group.
  • User Login, Logout with Correct User ID and password.
  • Password Protection Alphanumeric Password.
  • User Lockout on Multiple wrong attempts.
  • Password Length Settable.
  • History of Login Logout Of user.
  • Equipment Master Sensor TEMPERATURE and HUMIDITY Data Report.
  • Equipment Scanner Sensor TEMPERATURE and HUMIDITY Data Report.
  • MKT Report.
  • MKRH Report.
  • Alarm Event Report.
  • SMS and Email for Alarm and Events.
  • BIOMETRIC Access.
  • Audit Trail Report for User Login Logout.
  • Audit Trail Report for Equipment all activity Performed.
  • Audit Trail of Software
  • Header of the Reports with Customer Company Name, LOGO, Set Values, Set Values Limits, Time Stamp of Report Creation, Verification.
  • and more