Computer validation management cycle

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. 

Essentially, the eCTD is a transport format for facilitating electronic submissions. The eCTD serves as an interface for industry-to-agency transfer of regulatory information while at the same time, taking into consideration the facilitation of the creation, review, life cycle management, and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The eCTD represents a major advance in the submission of information to support an NDA. In the future, companies may be able to send their submissions to several regulatory authorities simultaneously with a single stroke of a computer key. 

The final staffing life-cycle phase is entitled maintenance and covers the prospective validation of new computer system systems and periodic revalidation of current computer systems. This phase is typically managed in-house, using work packages contracted to suppliers. At this stage, a set of... 

In conclusion, while RAD projects offer many advantages, they also pose certain risks, and thus require careful, competent, realistic management to ensure that they deliver validated computer systems. RAD must not be used as an excuse to circumvent necessary life-cycle controls and documentation. 

Compnters are widely used in analytical laboratories for instrument control, data evaluation, and data management, and are subject to all validation and verification activities. Verification and validation activities to assess compnter systems used in analytical laboratories cover all life-cycle phases, from nser Reqnirements Specifications, design, development, and manufacturing to installation and operation. In this case stndy, users of computer systems will find guidelines on ... 

---