Kay
QMS is a comprehensive and validated software that
covers Quality Control Laboratory , Quality Assurance
dept. and Regulatory Affairs. The objective of
the system is to control the product quality , assurance
of the quality of everything related to the product
including the process of production , implementation
of GMP (Good Manufacturing Practices ) , removal
of manual work and creation of an error free documented
system , saving the precious time of analyst from
doing calculations on calculator and then performing
the documentation of it . So the system saves time
and resources to enhance cost efficiency .
Functionality of the software for QC module is that it maintains all the test specification , offers formula wizard to the user to create test formula and get simple entry from user like wt. of the sample etc. then performs all the calculations and approve / reject /hold the material /product according to the testing. All the calculation i.e raw data report , Analytical reports , logs and graphical reports are generated automatically by the system saving atleast
50% of work load .
For Quality Assurance it offers international standard of documentation and maintain track records and generate graphical reports .
For Regulatory affairs it maintain all the documents of product registration
alert for registration renewal and information about pending registration.
QMS is a result of extensive research and
development for laboratory software . Kay QMS was validated under the CSVP rules and procedures
defined and explained by Eli-Lilly (Erl Wood - UK). Kay
releases upgrade versions of QMS and
performs validation for all upgrades.
Kay QMS has proven track record in Pharmaceutical
industry , it is was implemented at Eli-Lilly
Gohar in year 2002, successfully running in Getz Pharma
since year 2004 and at PharmEvo in end year 2006.
