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QUALITY CONTROL
MANAGEMENT SYSTEM
(QCMS)
A product for automating the
working of QAQC department of
pharmaceutical company.
ABOUT QCMS

•

QCMS is an Electronic Data Management System
designed to assist quality control groups .

It is designed for :• Carry out routine analysis
• Status of analysis at any time
• Proper control on specifications
• Critical review of data
• Comply to quality control stands for various
• Reduction in paper work
• Online distribution of documents.
• Complies 21 CFR Part 11.
Cont……..

•
•
•
•
•
•

Reminder for Documents due for Internal review.
Retrieving Historical version of documents.
All the specifications with pharmacopial version is well
controlled.
Less user interaction is required for analysis
Scheduling can be done for any batch.
All kinds of certificates can be generated online
Cont……..

•
•
•
•
•
•

Status of analysis can be monitored at any moment of time .
Find decision will be made by the system based on data.
Audit trail for all the transactions are maintained
Yearly trend data reports can be taken.
Option of connection with MS_Word and MS_excel.
Data can be exported in the required format.
QCMS PROCESS
Raw Material
RAW
MATERIAL
PHASE

INPROCESS
PHASE

Raw Material

Raw Material

Material

(Mixed Raw Material
as input
to In-Process)

Stage - 1

Stage - n
Finished Product

FINISHED
PRODUCT
PHASE

Packing

STABILITY
PHASE

Stability

Packed
Finished Product
Raw Material
RAW
MATERIAL
PHASE

Batch No.
B1
QC Ref. No.
QC1

Raw Material
Sampled
Released
Analysis

Raw Material

Batch No.
B2
QC Ref. No.
QC2

QC3

Material

(Mixed Raw Material
as input
to In-Process)
Batch No.
B4
QC Ref. No.

INPROCESS
PHASE

Batch No.
B3
QC Ref. No.

Stage - 1

Sampled
Analysis
Released

QC4

Batch No.
B5

QC Ref. No.
QC5

Stage - n
Finished Product
Batch No.
B25

FINISHED
PRODUCT
PHASE

Packing

STABILITY
PHASE

Stability

QC Ref. No.
QC25

QC Ref. No.
Packed
QC26
Finished Product
Care-QCMS Architecture on MVC Pattern
ASP.NET Page(AJAX,.ASCX
User Control, XSL)

Caresoft .net application Framework
Business
Wrapper
Class

Top Bar Control

Left
Bar

Working Area

Caresoft
.net Application
Framework

Exception
Block

Business
Class
Data
Access Layer

SQL server

XML
Various Status in Care-QCMS
Events

Batch Status

Sample Status

Batch Creation

Available

-

Assign Sample

Sample Recording

-

Sample Recording

Test Assignment

Sampled

Assign Test

Analysis

Test Assigned

Test Result Recording

Verification

Analysis Finished

Verify Sample

Approval

Verified

Approve Sample

Final Approval

SetApprovePass,
SetApproveFail,

Release Sample

Released,Retest,Fail

ApproveRetest
Released,Test or fail
Our Locations

• India
• Contact for Research Paper/White Paper/Schema :
Mr. Vishvas Yadav
Director ~ Codoca Mtvcola Marketing Advertising And

Outsourcing Pvt. Ltd. India , (India)
Phone 91-888472639, 91- 9036236527 , 91- 8884640956
Mail Id: sales@codocamtvcola.co.in
Thanks
To
All
Of
You…..

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Mission vishvas reasearch paper on qcms

  • 1. QUALITY CONTROL MANAGEMENT SYSTEM (QCMS) A product for automating the working of QAQC department of pharmaceutical company.
  • 2. ABOUT QCMS • QCMS is an Electronic Data Management System designed to assist quality control groups . It is designed for :• Carry out routine analysis • Status of analysis at any time • Proper control on specifications • Critical review of data • Comply to quality control stands for various • Reduction in paper work • Online distribution of documents. • Complies 21 CFR Part 11.
  • 3. Cont…….. • • • • • • Reminder for Documents due for Internal review. Retrieving Historical version of documents. All the specifications with pharmacopial version is well controlled. Less user interaction is required for analysis Scheduling can be done for any batch. All kinds of certificates can be generated online
  • 4. Cont…….. • • • • • • Status of analysis can be monitored at any moment of time . Find decision will be made by the system based on data. Audit trail for all the transactions are maintained Yearly trend data reports can be taken. Option of connection with MS_Word and MS_excel. Data can be exported in the required format.
  • 6. Raw Material RAW MATERIAL PHASE INPROCESS PHASE Raw Material Raw Material Material (Mixed Raw Material as input to In-Process) Stage - 1 Stage - n Finished Product FINISHED PRODUCT PHASE Packing STABILITY PHASE Stability Packed Finished Product
  • 7. Raw Material RAW MATERIAL PHASE Batch No. B1 QC Ref. No. QC1 Raw Material Sampled Released Analysis Raw Material Batch No. B2 QC Ref. No. QC2 QC3 Material (Mixed Raw Material as input to In-Process) Batch No. B4 QC Ref. No. INPROCESS PHASE Batch No. B3 QC Ref. No. Stage - 1 Sampled Analysis Released QC4 Batch No. B5 QC Ref. No. QC5 Stage - n Finished Product Batch No. B25 FINISHED PRODUCT PHASE Packing STABILITY PHASE Stability QC Ref. No. QC25 QC Ref. No. Packed QC26 Finished Product
  • 8. Care-QCMS Architecture on MVC Pattern ASP.NET Page(AJAX,.ASCX User Control, XSL) Caresoft .net application Framework Business Wrapper Class Top Bar Control Left Bar Working Area Caresoft .net Application Framework Exception Block Business Class Data Access Layer SQL server XML
  • 9. Various Status in Care-QCMS Events Batch Status Sample Status Batch Creation Available - Assign Sample Sample Recording - Sample Recording Test Assignment Sampled Assign Test Analysis Test Assigned Test Result Recording Verification Analysis Finished Verify Sample Approval Verified Approve Sample Final Approval SetApprovePass, SetApproveFail, Release Sample Released,Retest,Fail ApproveRetest Released,Test or fail
  • 10. Our Locations • India • Contact for Research Paper/White Paper/Schema : Mr. Vishvas Yadav Director ~ Codoca Mtvcola Marketing Advertising And Outsourcing Pvt. Ltd. India , (India) Phone 91-888472639, 91- 9036236527 , 91- 8884640956 Mail Id: sales@codocamtvcola.co.in