123ArticleOnline Logo
Welcome to 123ArticleOnline.com!
ALL >> General >> View Article

Caliber Lims

By Author: caliber universal
Total Articles: 3

OOT Trending – a proactive measure

Business Challenge
Identifying OOT results was a concern for the client for avoiding potential issues with marketed product, as well as avoid potential regulatory issues. The calculation of OOT trend for each every batch is complicated and cumbersome to perform manually or in excel sheets. There was a need for efficient and practical statistical approach to identify OOT results to detect when a batch is not behaving as expected. To judge whether a result is OOT, one must first decide what is expected and in particular what data comparisons are appropriate.
Based on the SOP the following decisions need to be made
• What statistical approaches are used to determine OOT criterion
• What data to be used to determine OOT limits
• What evaluation is performed if the minimum data requirement is not met
• What data should be used to update limits
• Who is responsible for comparing the result with the OOT criterion

Solution and Implementation

OOT calculations can be done on the fly in CaliberLIMS sample manager. OOT results are displayed to approver right after the sample analysis is submitted by the analyst. This helped the reviewer to do effective proactive measure in case there is an OOT for that batch.
CaliberLIMS has a capability of trending OOT in three ways:
• 3sigma
• Running average
• Giving a minimum and maximum range
This has helped the client to configure OOT for different products as per their SOP.
The solution is very flexible, effective and reduces redundant calculations that are being done by the analyst. An analyst can give the number of released batches to be compared with, subsequently the system takes the result value of previous batches and apply to the validated predefined formula in one of the of above mentioned ways and calculate the OOT.
This OOT is calculated in real time as when the test results are submitted and it is flashed to the reviewer before approving the results. This is of immense help to the QC manger, the manager will know the trend analysis and once he OOT is triggered by the system, the decision of OOS can be taken. Proactively the manager can issue a CAPA in case deviation and improve the process or material so that the test results across bathes are consistent.

Total Views: 253Word Count: 409See All articles From Author

General Articles

1. Why Eye Creams Are Important
Author: PharmacyOnNet

2. Preparing For Usa Basketball Tours Understanding The Organisations And Categories
Author: Brett Rainbow

3. Ipad Vs Smartphone Who Will Win The Experience Battle?
Author: Patrik Murphy

4. Avail The Service Of Radius Moving For Best Moving Experience
Author: radiusmoving

5. Hermal Mass Flow Meters - Finding A Value In Many Industries
Author: satheesh

6. A New Example For Cyber Threat Hunting
Author: Bradon Wilson

7. What To Do If Windows Is Unable To Run The Software Protection Service On A Local Computer.
Author: Bradon Wilson

8. The Hidden, Emotional Effects Of Acne
Author: Rahul Sharma

9. Importance Of Prescribed Supplements For Your Healthy Growth
Author: seotechincalteam

10. How Can I Invest In Cryptocurrency ?
Author: CryptoCoinX

11. Pharmasynth Offers Best Pcd Pharma Franchisee Opportunities For Business Partners
Author: jacobkayles

12. Ich Liebe Die Tatsache, Dass Es Zwei Kleider In Einem Geben Kann
Author: mekleid.de

13. Celebrate Your Partner’s Birthday By Sending A Stunning Flower Box
Author: Carl Glendon

14. What Happens During A Recession?
Author: Millennium-fx

15. Important Gold Trading Tips For Beginners
Author: Millennium-fx

Login To Account
Login Email:
Password:
Forgot Password?
New User?
Sign Up Newsletter
Email Address: