With the progression of technology, it has become evident that there is a place for electronic documentation in clinical research.

One area of particular benefit includes the informed consent process. Electronic informed consent (eIC) has the potential to offer great advantages over the traditional paper consent process. If used correctly, eIC can serve as an effective tool for educating study subjects, managing informed consent records, and ensuring research participants are made aware of new information or study amendments.

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While not directly called out as required in the Food and Drug Administration’s (FDA) Quality System Regulation (21 CFR 820), a good Validation Master Plan (VMP) is critical to executing a solid process validation program.

A Validation Master Plan provides medical device manufacturers with a roadmap, by outlining the process validation requirements and providing justification for these requirements. Therefore, medical device manufacturers should understand what makes for a good Validation Master Plan.

What is the Purpose of VMP?

The Validation Master Plan is intended to represent the manufacturing validation life cycle. It should be created concurrently with the design and development effort and can be used as a tool for project planning.

Medical device manufacturers would not begin a product realization effort without a Design and Development Plan. Similarly, a manufacturing effort should not begin without a VMP.

The VMP is beneficial for planning purposes because it identifies anticipated resource needs and provides key input into scheduling of project timelines. It documents the scope of the validation effort, including impacted product, processes, procedures, facilities, equipment, and utility systems.

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Passed in July 2012, the Food and Drug Administration Safety and Innovation Act has notably changed the Food and Drug Administration’s authority regarding the collection of fees, the manner in which reviews of drug applications are conducted, access of patients to medications, and the participation of stakeholders in the process.

The legislation is expected to affect domestic and foreign manufacturers of pharmaceuticals, devices, and biologics considerably in the coming years. As such, pharmaceutical executives should understand the impact of this legislation.

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