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Content archived on 2024-05-24

Process and Product Validation for SMEs


This project aims to support small manufacturing companies to comply with the complex and strict legislation regarding validation of processes and products (which are critical to health). This will be achieved by providing a workbook and software system to support SMEs in complying with the legislation (via a subscription service).
The project will focus on manufacturing sectors where control of processes and products is critical to health, specifically the medical equipment and pharmaceutical sectors. The project duration will be 18 months, and the wider impact of the project results will be facilitated by the VALIDATE web-site. The results are expected to improve health and safety of SME products, and reduce the burden of compliance, and reduce the risks of non-compliance to the legislation.

This project aims to support SMEs comply with the complex and strict legislation regarding validation of processes and products (in sectors critical to health).
This will be achieved by developing a novel methodology (workbook) for SMEs, which will guide SMEs through the activities of compliance with validation regulations. The aim is to increase confidence (to 100%) in the consortium SMEs that they comply with the standards.
A hypertext guidance system and a management software system will be developed, which will guide and support SMEs in compliance with product and process validation legislation. This will reduce the burden of the validation exercises by 50%.
The results will be assessed and their quality measured against the original user specifications. The results will be disseminated to a wide SME audience, reaching over 500 SMEs during the project, and will be available from the project internet site.

Work description:
The following main (exploitable) results will be produced:
- The "VALIDATE" workbook, containing a practical methodology for small businesses for process and product validation.
- The "VALIDATE" hypertext guidance system, which will use the contents of the workbook as expert knowledge and present it interactively to users.
- The "VALIDATE" software system, an integrated system providing the user with some statistical tools and reporting functionalities, specifically aimed at small businesses

To achieve the results successfully, the consortium will adopt a three phase plan:
Phase 1: Preparation:
During this phase, the full detailed project plan will be set out. A comprehensive survey of requirements will be performed. The requirements of the users will be fully collected, analysed and specified.
Phase 2: Implementation:
The development of the workbook, the hypertext system, and a software management system will be the main tasks within this phase. An evolutionary approach will be adopted for this phase to ensure that the users are presented with early results for assessment. The majority of activities within this phase will be performed in parallel.
Phase 3: Validation:
User acceptance and assessment of the achieved results will be the main activities.
The users will go through comprehensive training activities prior to the acceptance and assessment.
The results of the validations will be used for refinement of the results.
The results will be assessed for their quality and the impact that they have on the SMEs.
Throughout the project, dissemination activities will take place, including the internet site.
The site will contain the major project results, plus project information, and all the published materials.
The exploitation plan will be developed during the project, and will contain planned commercial activities.

The project will have 3 milestones and a mid-term review.
The first will be at month 6, when the requirements have been specified.
The mid-term review will be at month 9, when the methodology structure has been defined.
The second milestone will be at month 12, when the methodology workbook and guidance system have been completed.
The final milestone will be at the end of the project, when the "VALIDATE" management system has been developed and the results have been assessed.

Call for proposal

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Participants (5)