"Validation has become a costly, time-consuming, labor-intensive process. Traditionally, engineers have developed protocols from scratch or by cutting and pasting from old protocols. These methods are expensive and inefficient and lead to a lack of standardization."

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cGMP Systems Validation Protocol Module (VPM), a module in a suite of integrated software applications, is a validation document generation system that helps automate the tediously expensive validation process. VPM provides a multi-user, shared knowledgebase and knowledge management system to develop standardized qualification protocols. This system utilizes standardized validation guidelines containing test procedures and data sheets, along with templates, to rapidly develop qualification protocols. Once developed, protocols and their associated templates, test procedures and data sheets remain in the knowledgebase for re-use, knowledge sharing and requalification.

Designed to produce protocols quickly and efficiently using guidelines and ‘wizards’, VPM eliminates the cutting and pasting techniques of the past. VPM uses guidelines to deploy standardized validation methodologies.

Guidelines define the IQ, OQ and PQ or PV tests recommended for system qualification and can be purchased directly from cGMP Systems, or they can be imported from your own existing methodologies. Each guideline includes instructional information to help users understand not only what they should do to qualify a system but also provides answers to the inevitable question "Why do we need to perform this test?"

Knowledge capture and sharing is greatly increased through the use of VPM. Protocol tests and data sheets can simply be dragged and dropped from one protocol to another, thereby reinforcing standardization, decreasing training time and improving document generation time.

As with all cGMP Systems modules, VPM includes extensive security, change history and audit trail functionality.  VPM's features enable group collaboration, improve change control and improve GMP regulatory compliance.

When used with our Engineering Specification Module (ESM), protocol data sheets are dynamically linked to the current specification data. Manual transposition of data from engineering drawings and spreadsheets to the protocol is no longer necessary, thereby reducing the costs associated with protocol deviations and errors.