Validation Articles

Validation Deviations – An Important Part of Any Validation Project
May 20, 2013 | General Validation, Validation Articles
Validation deviations are just a part of life when you are working through validation protocols and test scripts; it’s highly unlikely that you will ever complete a full validation project without raising the odd validation deviation here and there. So what is a Deviation or Exception? It’s quite simple it’s an error or a failure [...]
New Book Release: Writing & Executing a Software Validation Protocol: Plain and Simple
May 15, 2013 | Software Validation, Validation Articles
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results. While this book was written primarily for those new to validation projects and the effort required gathering sufficient [...]
Software Validation Security Testing – 12 Items to Consider
May 7, 2013 | Software Validation, Validation Articles
I haven’t see a system yet that didn’t check password access, but most testing of Security features stops there. Even though Security is one of the critical “Big Three” drop-dead validation issues, it doesn’t get much attention by most companies. Therefore, you often see findings like this one made in an FDA 483: Testing of [...]
Software Validation in a Nutshell! The 5 Minute Guide to Understanding the Principles
April 19, 2013 | Software Validation, Validation Articles
Computer System Validation in a Nutshell! The 5 Minute Guide to Understanding the Principles 1. What is Software Validation? Software validation is part of computerized system validation (CSV). Computerized system validation defined as a documented evidence with a high degree of assurance that the software/computerized system, functions as per software design and user requirements in [...]
Top Tips When Creating a URS for a Purified Water System
April 9, 2013 | Process Validation, Validation Articles
A User Requirement Specification (URS) is issued by the user to define the system requirements. Issuing a URS serves many purposes. For example it: Specifies the system’s parameters, regulations, and standards Establishes the base for pricing the new system Establishes the base for design, manufacturing, and validation Specifies deliveries Try to keep the system requirements [...]
Top 22 Reasons Why Risk Assessments are So Difficult?
April 2, 2013 | General Validation, Validation Articles
We all know the story, we need to validate a process/equipment/software so let’s use a risk based approach to apply scientific rationale and just test the components that are critical and key to enhancing patient safety and product quality. In reality performing a successful quality risk management approach is very difficult and often leads to [...]
Common Mistakes Made in Software Validation Operational Qualifications (OQ)
March 25, 2013 | Software Validation, Validation Articles
Overly Complex Test Objectives The reason you don’t want to cram as many functional features as possible into one test is that, in case one of the functions fail, you end up having to fail of the functions. This is because, if you are testing nine different things simultaneously and there is a major crash [...]
Validation Master Plans Vs Project Validation Plans
March 13, 2013 | General Validation, Validation Articles
As with all validation life-cycle documents, a validation master plan is a formal document produced by the pharmaceutical manufacturer. The plan should require that all validation documentation is under a strict document control procedure with issue and revision of documents controlled by means of an approval tables, identifying the name, signature, date, and level of [...]
Technology Trends Facing Life Sciences in 2013
March 4, 2013 | Validation Articles
According to PMLive.com, pharmaceutical companies and other players in the life sciences industry need to get to grips with new and potentially disruptive technologies to help them emerge from a challenging operating environment, says a new report. It is no secret that drugmakers have been taking a battering in recent years on the back of [...]
Reducing Validation Time and Cost: How GAMP & Risk Based Approaches are Reducing Costs
February 18, 2013 | Software Validation, Validation Articles
There is an expression: “Tell me what you believe, and I will be able to predict how you will act!” Many life science organizations generally accept that computer system validation takes a long time, costs a lot of money, and is difficult to manage effectively. Computer systems validation is generally accepted to contribute 25% to [...]
Showing Insufficient Deviations to Support Comprehensive Testing
February 5, 2013 | Software Validation, Validation Articles
This one is tricky and by its nature highly controversial, deviations are not bad things when handled correctly they are a legitimate part of any system testing and should not be looked upon as bad work by the analyst. When an auditor assesses a system, they will rely on years of experience validating the same [...]
The Concept of Air Handling System Validation
January 29, 2013 | Equipment Validation, Validation Articles
The degree of cleanliness of air in the pharmaceutical manufacturing and related operations area should be established depending on the characteristics of products and operations in the area. In order to establish and maintain such standards, careful attention has to be exercised to keep the standards from the stage of design and construction through to [...]
Process Control Systems GAMP 5 Software Categories
January 21, 2013 | Software Validation, Validation Articles
In the article Validation Determination the use of categorising software was discussed and how this can support the approach to the validation. In this post we are looking at types of software which fall in to these categories for Process Control Systems / Automation Systems. Categorising software is used to support the approach to the [...]
Software Master Validation Plan
November 6, 2009 | Software Validation, Validation Articles
The validation plan is a strategic document that should state what is to be done, the scope of the approach, the schedule of validation activities and tasks to be performed. The plan should also state who is responsible for performing every validation activity. Once reviewed the validation plan should then be signed off by the [...]
No Longer 3 Golden Batches, So Just How Many Process Performance Qualification Batches Should I Run?
December 10, 2012 | Process Validation, Validation Articles
The debate on the number of batches used to determine if a process is validated or not has come under some scrutiny since the update of the US FDA’s Guide to Process Validation in 2011. As a result of the update, industry has tried to come up with a number of ways to help to [...]
Event Driven and Time Driven CSV Revalidation
November 27, 2012 | Software Validation, Validation Articles
Revalidation is part of keeping your system in a validated status. It can be Time-Driven or Event-Driven. It is recommended that a revalidation SOP be generated to cover the determination of the need for, and the documentation requirements of, any revalidation effort. A full validation effort encompasses a systematic and comprehensive testing of all cGxP [...]
Product Selection Criteria for Retrospective Validation
November 20, 2012 | General Validation, Validation Articles
For a product to be considered for retrospective validation, it must have a stable process, that is one in which the method of manufacture has remained essentially unchanged for a period of time. The first step in the product selection process is therefore to obtain a summary of changes in the method of manufacture. In [...]