INFORMATION TECHNOLOGY POLICY

 

Intox does not have a single, separate document entitled “Information Technology Policy”. However, all IT related operational aspects have been well addressed so as to comply with the OECD principles of GLP. Intox SOP/MN/30 entitled “Computer / Electronic Information Technology System” is the master SOP for this purpose. It is to be read along with several other related SOPs.

 

IT system at INTOX is a general purpose, multi-user system. It provides electronic services such as raw data capturing via Provantis (LIMS), word-processing, spreadsheets, e–mail, databases etc. and provides a gateway to internet. The IT system at INTOX would provide the staff with secure tools to improve business processes. The result is increased efficiency and effectiveness.

 

Access to the system is via workstations operating as Windows-family operating systems. These workstations connect to INTOX Server over a Windows network through a local area network (LAN).

 

IT systems at Intox are designed to comply with OECD GLP principles defined in OECD GLP guidance document no. 17. To meet this goal, following procedures have been standardized and documented in the form of SOPs as listed below.

 

SOP Number                         SOP Title

 

INTOX/SOP/GN/41        Use and maintenance of Computerised Systems.

INTOX/SOP/DP/04        Data security backup system.

INTOX/SOP/GN/42        Installation of vendor supplied software.

INTOX/SOP/DP/06        Statistical programme validation and record keeping.

INTOX/SOP/GN/93        Validation of Computerised Systems.

INTOX/SOP/GN/79        In-house IQ, OQ & PQ of Computerised system.

INTOX/SOP/GN/92        Provision of IT resources and complaint Management.

INTOX/SOP/GN/94        Data security compliance management

INTOX/SOP/GN/91        Preventive Maintenance.

INTOX/SOP/AR06          Archiving of electronic media records

INTOX/SOP/GN/78        User requirement specification