Validation Project Management Organization

The presentation phase The VIP team formally presents the profitability recommendations consistent with the objectives and constraints of the workshop and their implementation plans to the steering committee or the project management team. The steering committee then approves those recommendations that pass muster and authorizes the project team to begin the implementation effort. Often, this approval is conditional on early validation by subject matter experts within the project owner s organization, but not present within the workshop. This external feasibility check is meant to provide support to the project team for any additional resources and schedule time needed to fully incorporate the improvements into the project scope of work. 

To start with, the project organization must be defined. The different positions must be defined and people need to be found with the necessary knowledge to fill these positions. The most commonly required areas of expertise for a project leader are organizational know-how, social skills, project management knowhow, time management, validation know-how, and general technical know-how. A team member should have expertise in communication skills, validation know-how, and detailed technical know-how. 

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. 

The role of senior management is not limited to validation policies and procedures. Senior managers should also sponsor validation projects and ensure that the necessary supporting organization is established. Project roles will normally include the following ... 

The overall project itself requires formally structured planning and control in addition to the validation plans for the computerized operation. To provide this, a project and quality plan from the pharmaceutical manufacturer (or its nominated main contractor) is normally developed as a separate and complimentary document and needs to overview all activities, resources, standards, and procedures required for the project. The plan should define project-execution procedures, quality management procedures, engineering standards, project program, and project organization (with authorities and reporting responsibilities), and reference the project validation plan. There are instances in which the project and quality plan and the project validation plan can be combined into one document. 

This chapter has outlined the basic approach to implementing and validating an MRP II system. Managers must tailor their project approaches to match their particular business organizations, availability of in-house and external resources, scope, and size of implementation. Snccessfnl implementation, validation, and operation of an MRP II system will also depend to a great extent on ensuring the project does not "... 

There are two questions most commonly faced by validation organizations "What do we validate " and "How does validation differ from normal project activities such as Factory Acceptance Testing and Site Acceptance Testing " The answers are that we validate GxP critical aspects of the system, i.e., those aspects that can have a direct or indirect impact on product quality, safety and efficacy. Validation is essentiaily a term used to denote the additional rigor applied to the management and documentation of the each phase of the development and operational life cycle of the system. 

Today safe management and disposal of radioactive waste has become a valid objective in itself, independent of further exploitation of nuclear energy. However, in the public acceptance debates the two areas remain intimately connected. Anti-nuclear organizations commonly support political opposition to repository projects and some make their position even clearer by proposing to support disposal projects under the stringent condition that further peaceful use of atomic energy is abandoned. 

As stated, coordination is a balanced choreography of teamwork across the various elements of an organization and throughout the life cycle. Coordination facilitates harmonious organization of project efforts. It underscores the culture, executes the commitment, and validates the communication that management is tasked with achieving on successful projects. 

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