Validation management

The interventions compared need to be relevant to the health and social care choices faced by decision-makers. Unless do nothing is a valid management strategy, comparison of a new intervention with placebo is not appropriate for an economic evaluation. Since there are a number of dmg therapies and non-pharmacological approaches to the management of people with dementia, the relative cost-effectiveness of these needs to be... 

It is the responsibility of the technical services manager, validation manager, and contractors to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

Team comprising micro lab in charge, QC manager, production manager, and validation manager will be responsible for investigation, which will include, but not be limited to ... 

OECD (1999b) Final record First Meeting of the OECD Validation Management Committee for the Screening and Testing of Endocrine Disrupting Substances — Mammalian Effects, Tokyo, Japan, 8-10 February 1999. Paris, Organisation for Economic Co-operation and Development. 

Problems encountered in HPLC analysis most often stem from a lack of knowledge of the influence of the slight variation of the experimental parameters (pH, temperature, solvent composition, flow rate, etc.). The analyst has to set up the list of parameters and their possible interactions. There are hardware parameters (e.g., flow control, temperature control, lamp current) and software parameters used to interpret and report the results from stored data. The use of factorial designs is of great help. Software such as Validation Manager, from Merck, produces, in a table for each parameter and interaction, its percentage and confidence interval as well as information to help the analyst in concluding the study. 

At the completion of the documentation, a final report should be drafted to indicate the conclusion and acceptability of the installation. The final report must be approved by the departments that approved the protocol. These are likely to be engineering/technology, production quality assurance/quality control and operations, and the validation manager. Approval of the final report by the relevant departments makes the way clear for proceeding with operational testing. 

The notifications list the duties of the validation manager as requested by article 10 of the control regulations. A concrete comparison of the notification with other countries requirements is difficult due to the nature of the translation process for example, the interpretation of synchronous validation as being equivalent to concurrent may be misleading. 

Computer System Validation Management. The type of committees, the definition of project managers (responsible users), and their respective duties should be described in detail. 

During the implementation or update process, the introduction of a computer validation management cycle will provide a top-down approach to integrate computer systems validation strategies in order to support the project. Figure 5-1 suggests a computer validation management cycle. 

As with any process, an improvement mechanism is required in order to enhance the computer validation management cycle. The improvement mechanism will be identified based on experience in using the SLC, validation practices, and the analysis of software metrics. The following sections describe the overall scope of each document or activity. Detailed description of each activity can be found in other chapter of this book. 

FIGURE 3.2 Relationship between Prospective and Retrospective Validation Management. 

Throughout the validation management process there shonld be formal opportunities to review validation practices. The status of validation work is likely to change some existing systems may be decommissioned, new systems may be planned, and the priorities of the current inventory work may vary due to changing company needs. Validation Policy and Validation Procedures may change as a result of new regulatory requirements or feedback from project experience. 

Test facility management - System owner - IT responsible - Validation manager - Validation team - Quality Assurance... 

Validation Manager, Pfizer Limited, United Kingdom... 

---