By Robert McDowall, Roger Smith
Guiding chromatographers operating in regulated industries and assisting them to validate their chromatography info platforms to satisfy facts integrity, enterprise and regulatory wishes. This e-book is an in depth examine the existence cycle and documented proof required to make sure a approach is healthy for objective in the course of the lifecycle. first and foremost supplying the regulatory, information integrity and process existence cycle specifications for computerised procedure validation, the publication then develops right into a advisor on making plans, specifying, coping with chance, configuring and checking out a chromatography facts approach prior to liberate. this is often via operational facets comparable to education, integration and IT help and eventually retirement. All components are mentioned intimately with case reviews and sensible examples supplied as applicable.
The e-book has been rigorously written and is correct modern together with lately published FDA info integrity tips. It presents unique suggestions on sturdy perform and expands at the first variation making it a useful addition to a chromatographer’s booklet shelf.
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Extra resources for Validation of Chromatography Data Systems Ensuring Data Integrity, Meeting Business and Regulatory Requirements
Incidents and problems with the operational CDS need to be documented, investigated and resolved where appropriate. Occasionally this may require the changes to the system that is the subject of the next chapter. ●● Chapter 32: Change Control and Configuration Management. No system retains the initial configuration for long once operational as changes will occur in all layers of the system. Controlling these changes and managing the overall system configuration is essential for maintaining the validation status of the CDS.
So we will start at the beginning and look at the first stages of the systems development life cycle (a defined life cycle is one of the foundations of computer validation that will be discussed in more detail in Chapter 6): ●● Understanding and optimising the underlying business process. ●● Defining and controlling the validation throughout the whole life cycle (writing the validation plan). ●● Specifying what you want the system to do (writing a user requirements specification). ●● Selecting the most appropriate system using the requirements defined in the URS on an objective basis rather than a subjective approach using a glossy brochure.
Overall, the aim is to give any reader the practical basis and confidence to perform any of the topics covered by this book. 2 Part 1: Understanding the Basics This part has been greatly expanded compared with the first edition of this book and now consists of six chapters that are used to introduce the topic of CDS validation and set the scene for the remainder of the book: ●● Chapter 2: Introduction to Chromatography Data Systems. This provides an introduction to the main functions of a chromatography data system, how they have evolved over the past forty years and how they need to evolve in the future for better efficiency and regulatory compliance.
Validation of Chromatography Data Systems Ensuring Data Integrity, Meeting Business and Regulatory Requirements by Robert McDowall, Roger Smith