About Volunteering with LSIT

We are a non-profit, 501(c)(3) organization focused on pulling together the regulatory agencies, the standards institutes, the healthcare and life science communities and the IT industry to drive change for earlier adoption of IT and compliance with critical processes and issues such as Part 11.

The Issue

LSIT is focused on enabling trust of information technologies utilized in medical research, medical product development, governmental approval process and patient management. LSIT believes if the life and health sciences community and the government regulators can come to trust IT as a valuable tool it will expidite the process from discovery to the patient.

The Solution

LSIT's first effort is to develop Good Informatics Practices (GIP) in conjunction with international standards bodies and best IT practices. Our Scope will be range from research on through product commercialization and to the patient. We intend to develop a deep, publicly available guidance addressing the implications and requirements of both the gauntlet of regulatory requirements, such as Title 21 CFR Part 11, as well as the most applicable and robust standards and practices of ISO, IEEE, CMM, SEI, PDA, GAMP, GCDMP, HL7, and the cGxPs.

LSIT believes that publishing the GIP Guidance will serve as a first step in achieving a trusted reference specifically tailored to the IT departments of the life and health sciences community and the government regulators themselves. Additionally, it will offer the financial decision makers a better understanding and knowledge of industry requirements and allow them to better to manage and control costs, resource allocation, and ROI.

We have recently begun to engage the U.S. Food and Drug Administration in our GIP development cycle to ensure we have the appropriate level of buy-in from regulators.

The Bottom Line

If we can make sense of the regulatory requirements for IT and pull together the Standards Organizations that are most appropriate in Life Sciences, we can help companies leverage better, faster, and less costly IT solutions from discovery to commercialization.

The GIP Difference

The depth and scope of Good Informatics Practices will rival that of other GxPs (See Scope of GIP). GIP will be a true guidance document that not only promises to save the life sciences industry significant time and costs, but fare more importantly promises to rapidly advance global public health through the more rapid development of medical advancements.