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Welcome to the AskaboutValidation forum.
Consult this forum for the latest news concerning the askaboutValidation community.
12-02-2013, 10:37 AM
Welcome to the AskaboutValidation Community! Introduce yourself here so we can get to know you better.
01-06-2014, 01:05 PM
Use this thread to post any questions you have about calibration and metrology.
calibration of in process...
02-27-2014, 02:53 AM
Cleaning Validation - what are your methods
04-17-2014, 11:16 AM
Equipment Validation - PLC's, SCADA's, Laboratory Equipment, Balances, pH Meters
04-17-2014, 12:25 AM
Good Validation Practice - For Process and Equipment Systems
Compeessed Air validation.
04-17-2014, 06:13 PM
Confused about HVAC's, post all your questions here.
Routine particle control
04-15-2014, 11:58 PM
Ask about validation of lab equipment and the methods used.
Swabbing method validation
04-17-2014, 05:38 PM
Process Validation or...
04-18-2014, 05:12 AM
Applicable Regulations, Standards, and Guidelines, Planning, Design Basics
Ozone in Pre-treatment
04-17-2014, 06:02 PM
How do you Evaluate Risk?
Risk Assesment SOP
03-14-2014, 01:56 PM
The Regulations and the Predicate Rules.
what are minimum requirements...
04-14-2014, 01:23 PM
Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Final Directive on Annex 11
10-21-2013, 12:24 PM
The Cloud is Coming - Are you ready to Go-Live?
Cloud Operational Work...
02-01-2013, 02:12 PM
What Software do you use In-House. What are the Pros and Cons
What is the best LIMS...
03-12-2014, 03:05 PM
A Risk-Based Approach to Compliant GxP Computerized Systems
computer system validation
01-06-2014, 08:04 AM
Best Practices - Worst Practices
Add on software
04-07-2014, 02:19 PM
At the heart of SAP functionality are approximately 10,000 data tables....need to know about the validation aspect?
Computer system validation
02-06-2014, 06:56 AM
Is it Software ? Is it Firmware - The Debate goes on!
Time to validate a SCADA
03-20-2014, 03:41 PM
Questions about CSV Documentation list them here.
Formulas in Statgraphics,...
10-26-2013, 04:09 PM
A robust network is also a well designed network!
Validation Plan for Networks
02-01-2013, 08:07 PM
Servers are auditable components of a system, post a question to find out more!
How to validate/qualify a...
12-30-2013, 06:23 PM
Assessing your suppliers is one of the key aspects of good validation practice. Post all supplier questions here.
Validation for change in...
08-26-2013, 01:13 PM
How do you create your MVP, who reviews it, who owns it?
Validation Plan for Robotic...
01-16-2014, 03:02 AM
FAT’s and SAT’s what is the difference between both of them. What details do you put in yours?
Difference between SAT and...
10-16-2013, 01:57 PM
This section has being created to discuss best practices for creating URS documents.
08-16-2013, 06:22 AM
Functional design specifications and how to create a successful one that meets all of the URS requirements.
DQ Outline Protocol based on...
11-24-2012, 07:56 AM
How do you set up your RTM documents, how long does it take you to create one from scratch? What do you trace in your RTM?
01-16-2014, 01:54 PM
What type of checks do you include in your IQ
Updating an IQ for COTS
06-19-2013, 03:15 PM
What type of checks do you include in your OQ
12-19-2013, 09:52 PM
What type of checks do you include in your PQ
Performance Qualification of...
03-05-2014, 11:31 PM
How do you record your deviations and discrepancies and how do you close them out?
01-11-2014, 06:26 AM
How detailed is your summary report, what details do you include in it?
Validation Summary Report...
11-24-2012, 07:58 AM
PART 211 - Current Good Manufacturing Practice
Hard Gelatin capsule shell...
Today, 06:16 AM
GAP - Good Auditing Practice Discussion Board
How does your organization...
06-12-2012, 05:34 PM
GCP - Good Clinical Practice Discussion Board
Free ICH-GCP Online Course
12-06-2013, 12:45 PM
GDP - Good Documentation Practice & Documentation Discussion Board
can Regulatory head...
04-14-2014, 12:47 AM
GEP - Good Engineering Practice Discussion Board
RLAF Velocity at working...
01-15-2014, 08:28 AM
GLP - Good Laboratory Practice Discussion Board
OOT criteria in API Analysis
01-03-2014, 10:11 AM
Quality Management Systems - ISO 9001:2000
Basic Concept of Quality...
01-27-2014, 11:45 AM
Quality Systems Regulations - The Law.
Training records - signatures
09-29-2013, 03:00 AM
All questions answered!
An Easy to Understand Guide...
11-01-2013, 01:51 PM
Please add any useful validation definitions or acronyms that our community may find useful
HVAC for secondary packaging
12-19-2012, 08:32 AM
This section is available to post any useful templates that other members may find useful in their own projects
Mlt validation protocol
04-08-2014, 03:47 PM
This thread is specially designed for our members to upload white papers of interest.
A Validation Approach for LIMS
03-12-2014, 03:02 PM
If you have any presentations that you think would be useful to other members, please feel free to post them in this section
Reference standards and...
04-04-2013, 04:21 AM
Six Sigma is a highly disciplined process that helps us focus on developing and delivering near perfect products and services
Sigma value for Process...
03-27-2014, 10:49 AM
(Component preparation, Formulation, Sterile Filtration & Lyophilization)
Fill & Finish Consideration...
05-11-2013, 06:52 PM
(Process Trends, Disposables & Utility-Facility Design)
Guide to Disposal of...
08-13-2012, 11:43 AM
Validation plan for ELISA...
08-27-2012, 12:26 PM
(Regulatory Updates across globe and Quality assurance)
FDA Guidance: Allowable...
03-18-2014, 05:26 PM
(Handling lab,Pilot, Scale-up and Manufacturing operations)
PQ and PV of fermenter
10-10-2013, 02:41 PM
Discuss the latest technologies, takeovers and turn of events in the life science world.
Pda technical report 59
03-28-2014, 11:26 AM
Anything that doesn't fit in the main forum, please post it here.
question on USP<61>
04-16-2014, 03:43 PM
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