Validation Management Cycle

The implementation or update of a computer system is planned and executed in accordance with the organization s own project management practices. It is the project manager s responsibility to take into account the technological requirements, standards, procedural controls, regulatory requirements and related guidelines, and industry standards. 

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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. 

Policies define the general principles and philosophy that are required within an organization. Each company should have written and approved validation policies that communicate the expectations of senior management for the execution of a validation project. 

Retrospective validation or qualification is discouraged, but may be applicable in some situations, where a statistically significant number of batches with consistent formulas, procedures and analytical methods are available. Sufficiently detailed past processing and control records must be available for retrospective validation studies to be considered. 

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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. 

When I wrote this in 1993,1 had hoped to define validation in terms of how it was to be accomplished. I also introduced the concept of a validation life cycle (see later section) as the appropriate means by which to manage its... 

A management review will usually be conducted periodically, with one or more validation reports used as feedback on the overall validation program. Although shown as the last phase of management cycle, reviews can and should take place throughout validation. The review endeavors to draw out lessons from the validation conducted to date, to consider the impact of any regulation developments, and to report any recommendations. The overall aim is the continuous improvement of the company s validation capability. 

The approach to standardized software should follow a variant of the V-Model called the X-Model (see Figure 14.1). Assuming that the standardized software has been developed under a suitable quality management, the end user validation can be abridged from the full bespoke software validation life cycle. 

Following an established validation life cycle, such as the V-Model promoted by ISPE, is a proven method of building Quality Assurance into software projects. Good project management and validation practices are close cousins. 

One of the major factors to be considered when implementing a GxP-compliant EDMS is validation. The basic validation approach is no different from that applied to other information management systems such as MRP 11 or Laboratory Information Management Systems (LIMS). An approach based on the validation life cycle in GAMP is appropriate. Figure 34.3 shows how validation documentation relates to typical project activities. Validation permeates all stages of the implementation process, as described below. 

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What is wrong with this model Nothing in principle, but the question arises, "What about validation " The validation life cycle includes specification, design, build, installation and qualification, which is not greatly different from the classic project management model that was rejected earlier in this section. 

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. 

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

Guidances recommend an integration of software life-cycle management and risk management activities. Software validation and verification activities must be conducted throughout the software life cycle [12,14]. Software verification and validation are terms frequently confused. Software verification is defined as the process that provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase... 

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