Manufacturing Resource Planning validating

Configurable application software usually includes custom configurable packages such as Manufacturing Resource Planning (MRP 11), Documentum , Maximo and so on. Validation of such systems requires an audit of the supplier and validation of any bespoke application software. 

Validating Enterprise/Manufacturing Resource Planning Systems... 

The basic validation approach is no different from that applied to other information management systems, such as a Manufacturing Resource Planning (MRPll) system or a Laboratory Information Management System (LIMS). An approach based on the validation life cycle in GAMP [4] is appropriate. Figure 10.3 shows how validation documentation relates to the project activities. 

This section describes two examples of IT applications that require their supporting networks to be validated. The first example describes a Manufacturing Execution System (MLS) based on a LAN and the second example describes an Enterprise Resource Planning (ERP) application that uses a WAN. 

The purpose of this book is to provide a generic format for a Master Validation Plan, also often called a Validation Master Plan (VMP), using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. The intent is to show basic format and samples of contents for all the sections of the plan, because it provides a road map for validation to establish FDA requirements master validation procedures, validation programmes, execution protocols, and resources planning and scheduling. 

The pharmaceutical manufacturer must ensure that personnel are trained to an appropriate level in GMP and validation planning and requirements to enable them to adequately perform their function. This applies to any resource used in connection with GMP compliance and validation life-cycle activities and documentation. A training program should be in place and individual training records maintained. The records and suitability of external resources used by suppliers or contractors should also be examined. 

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. 

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. 

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