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……..
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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……..
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•
•
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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.
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