By Robert McDowall, Roger Smith
Guiding chromatographers operating in regulated industries and supporting them to validate their chromatography information platforms to satisfy facts integrity, company and regulatory wishes. This ebook is a close examine the existence cycle and documented facts required to make sure a approach is healthy for objective through the lifecycle. before everything delivering the regulatory, info integrity and procedure lifestyles cycle requisites for computerised process validation, the ebook then develops right into a advisor on making plans, specifying, handling hazard, configuring and trying out a chromatography facts procedure prior to unlock. this is often through operational features equivalent to education, integration and IT help and at last retirement. All parts are mentioned intimately with case reviews and useful examples supplied as acceptable.
The publication has been conscientiously written and is true brand new together with lately published FDA information integrity tips. It presents specified tips on reliable perform and expands at the first variation making it a useful addition to a chromatographer’s e-book shelf.
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Additional info for Validation of Chromatography Data Systems Ensuring Data Integrity, Meeting Business and Regulatory Requirements
Sample text
In addition, this chapter begins the discussion on risk based second person review by looking at which audit trails and the types of work that should be reviewed. 12. If you are new to the subject, these chapters are intended to give you an understanding of the topics and to lead to further reading if necessary. It also provides a current refresher for experienced computer validation professionals who want an update to the subject. 3 Part 2: Planning the Work Planning any validation project is critical and Chapters 8–11 cover the following topics in this area: ●● Chapter 8: CSV Risk Management – System Risk.
The role of a CDS in research and development and production (GMP) can be for determining the impurities of raw materials and finished products, in process control and stability testing, whilst in GLP development laboratories a system can be used for the measurement of a drug and their metabolites in biological fluids from non-clinical and clinical studies to determine the absorption, distribution, metabolism and excretion (ADME) of the compound. Regardless of the role of the regulated laboratory, there is a need to validate to show that the CDS, including LC-MS and LC-MS-MS data systems, are fit for their intended use as required by the applicable GLP or GMP regulations as well as 21 CFR 11 (electronic records; electronic signatures rule) and EU GMP Annex 11.
1 Are the User Requirements Adequately Specified? 1 What Do the Regulators Want? 1 All is Well or Are There Problems? 8 Has the Test Passed or Failed? 1 What Do the Regulators Require? 2 What Do the Regulators Require? 7 How Should the Second Person Review be documented? 1 What Do the Regulators Want? 1 Business Rationale: How Important are Your Data? 2 What is Backup and Recovery? 7 Hot or Cold Backups? 1 What Do The Regulators Want? 1 Single Document or Multiple Documents? 1 What Do the Regulators Want?