Solution for Pharma Industry
Introduction

The Pharmaceuticals Industry comprises of all departments like any other organizations but the major critical department is the Research Laboratories wherein the security is of major concern as it is vulnerable to threats like product tampering this can be neutralized by restricting access of the unauthorized users in the secured premises.

Several ready solutions to assist the Pharma sector in Good Manufacturing Practices (GMP), such as:

Key Features

  • Door Interlock for the Clean Rooms and other production facilities for Good Manufacturing Practices.
  • Access control measures to restrict movements of personnel across production facilities to prevent contamination, as per the US FDA guidelines.
  • Biometric logical access for critical Pharma machinery integration possible (PLC).
  • 21 CFR Part 11 compliant software.
  • Rack level access control in the Data Centre and Server Room.
  • Time Synchronized Access Control Events integrated with CCTV at critical access areas.
  • Access Control at any other vital points where it may be necessary to restrict or regulate entry.
  • Centralised Multi-location recording and analysis of staff attendance in factories, branches, warehouses etc with an OTP (One Time Password) to maximize authentication of fingerprint registration and to control Date Time Management.
  • Enterprise level in-house developed Cloud based software platform with a number of very useful MIS Reports and analysis for the management.

smart-i Solutions

  • Door Interlocking System (DIS) for Clean Rooms etc, to control Dust/ Airflow/Temperature:- The basic logic of DIS says that a door will open only if one or more doors, under the given logic, are closed. The door logic is authorised user configurable. For example, while Door 1 is open Door 2 may open too but not Door 3 which will open only when Door 1 is closed. Smart I DIS can control up to 8 doors, interlocking them in a single loop.

  • Access Control System for Production/Admin/Lab with restrictions as per US FDA Policy:- If a user is permitted entry to one type of lab he will be denied entry to another lab on the same day, to prevent cross contamination, in keeping with "Good Manufacturing Practices (GMP), for Finished Pharmaceuticals".

  • Biometric Logical Access Integration with PLC:- Helps ensure that the production of a batch commences only when authorised by the QA.

  • 21 CFR part 11 Compliant Access Control Software:- The Smart I Access Control Software is 21 CFR Part 11 Compliant. It has MS SQL Database at the backend and generates a complete Log file for all the Transactions/Events/Changes/Editions in the software.

  • Rack Level Access Control in the Data Centres and Server Rooms:- This is a 2 tier access control solution wherein the 1st tier provides access control on the door to the Server Room or the Data Centre. The 2nd tier provides access control at the Rack level i.e. on each Rack. This solution is available for new racks with OEM arrangement as well as in the form of a retrofitting solution for the existing racks.

  • Time Synchronized Access Control Events integrated with CCTV and Access Control Integration:- For added security and audit.

  • Access Control at any other points of entry:- It may be required to restrict or control access at a number of other locations in a Pharma facility. Smart i Systems can be of assistance.

  • Centralised Multi Location Time Attendance System, with an OTP and with centralized monitoring:- Smart I offer multi location Web Based Attendance Software solutions which can be monitored real-time by the central office. The One Time Password or OTP maximises authentication of fingerprint registration, date/time recording etc for better control.

  • Web Based Enterprise Level in-house Software:- Enterprise level in-house developed Web based software platform with a number of very useful MIS Reports and analysis for the management.

  • Visitor Management System:- Under the Smart i VMS one can specify locations where an authorised visitor can gain access and not at any other.

smart-i Pharma Solution
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