Project validation plan

Ongoing evaluation periodic review intervals Use of project validation plans Support programs and procedures Reference documents and definitions... 

The project validation plan is for individual projects (including equipment) or systems and is derived from the validation master plan. The project validation plan should be closely linked to the overall project and quality plan. 

The project validation plan is a live document that should be reviewed against each life-cycle step and any other validation milestones (as a minimum). Any changes to the plan should be identified on a revision history section within the document. The plan should be retained in the validation file and should be easily accessible. 

In the case of a computer system applied to a live manufacturing process and integral with plant equipment and the process itself, the project validation plan should specify the relationship of the computer system qualification activities and documentation with that of the corresponding plant equipment qualification and process validation. Indeed, the qualification activities and documentation of these elements of a computerized operation are sometimes combined. 

Execution of the project validation plan will provide control and full documentation of the validation. 

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. 

As part of the supply contract each supplier or subcontractor needs to provide a corresponding project and quality plan to identify and outline the procedures, standards, organization, and resources to be used to align with the requirements of the pharmaceutical manufacturer s project. The contractors and suppliers involved with GMP work should reference the project validation plan and identify the specific requirements that are to be addressed to ensure the appropriate level of documentation in support of the pharmaceutical manufacturer s validation program. 

It should be recognized that the URS is the base document for developing and testing the computer system and needs to provide clearly defined and measurable requirements. Authorities and responsibilities for provision of information for the URS must be stated in the project validation plan. 

The tender package documentation needs to provide all the elements necessary to define the project, and typically includes the project validation plan, a detailed scope of work, the URS, the documentation deliverables, and the associated commercial documentation. 

A decision not to perform the review (e.g., evidence that code is developed under a quality system and formal reviews have already been conducted and reported) should be documented in the project validation plan, complete with the rationale. It is recognized that under its software quality assurance program the supplier may conduct similar examination of the software using only internal resource. Considering GMP implications, the pharmaceutical manufacturer would normally require that the software designer or programmer does not carry out any software review in isolation. 

Qualification is the process of establishing appropriately documented verifications and tests that provide a high level of assurance that a computer system will operate in accordance with predefined specifications. The specific approach to be used for each level of qualification should be outlined in the project validation plan and needs to focus on the critical parameters, data, and functionality of the computer system. While there are no absolute lines to be drawn between qualification testing of a computer system, it is recognized that the qualifications listed below provide the necessary control and continuity throughout the validation life cycle and must be approved for the system to be released for use in the GMP environment. 

The validation report is a comprehensive summary that documents how the project validation plan has been satisfied. With reference to the qualification summary reports, the validation report serves as the approval document for all life-cycle activities and is the mechanism for releasing the computerized operation for pharmaceutical manufacturing use. Recommendations may be made for any follow-up audit or additional testing. 

The validation report must record all conclusions regarding the execution of the project validation plan, and for the satisfactory operation of the computerized operation in its operating environment it should be clearly stated as approved or not approved. 

Written procedures shall define how the system will be used and controlled, and periodic review of these procedures and the validation documentation status must be carried out. The periodic review procedure should define responsibilities and should include predetermined criteria for reporting that computer system validation is being satisfactorily maintained in alignment with the project validation plan. A GMP risk assessment should form part of each periodic review to reconfirm (or not) the findings of the previous risk analysis and provide information for any revalidation that is considered necessary. 

Project validation plans should be started during the early stages of a project. Initial project concepts and planning estimates should be elements in the creation of a project validation plans. The initial project verification activities will assess the project team s capability to produce a validated system and provide input for defining the level of testing effort expected. Project verification will identify any critical deviations to the expected project timing and quality levels, as well as other issues affecting the timely approval of the validation report. 

Changes are proposed, documented, requested, evaluated, approved, and tested prior to implementation. The quality unit should be responsible for managing both the entire process and all corresponding documentation associated with the change. Change control typically begins at an SDLC milestone defined in a project validation plan. The CRS should at least be fully designed, documented, validatable, and implementable. 

Validation Plans record standards, methods, and personnel involved to assure quality through the system development life cycle and to establish the adequacy of the performance of the computer system. The term Validation Master Plan is typically used for large or multiple computer system validation projects. Validation planning should be initiated at the earliest practicable opportunity and may be reviewed and updated through subsequent stages of the project. 

This is essentially the same document as described earlier for the Project Initiation phase but defining the scope of the supplier s role and responsibility. The Supplier Quality Plan should act as an extension to the Supplier Proposal and Contract of Supply. The Supplier Quality Plan should be approved before the Functional Specification is approved. If the supplier is an internal function of the pharmaceutical or healthcare company, these plans do not need to exist as separate documents but rather can be integrated within overall project Validation Plans, Project Plans, and Quality Plans. 

A project Validation Plan should be established for each IT application. The plan has the character of an SOP with the usual administrative regulation for these documents. The plan comprises the following elements ... 

Application software can be released for use if the project Validation Plan has been satisfactorily completed. This needs to be documented in a Validation Report. 

The project Validation Plan should take into account the following elements ... 

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