The Underpinnings of Good Informatics Practices

Seminar Overview | Agenda | Seminar Rationale

Seminar Rationale

Over two hundred senior life sciences professionals, from around the globe revealed the key areas of greatest need in their industry: IT Security, Data Management, Testing & Validation, and IT Infrastructure Operations. The results of this 2005 online survey conducted by the Life Sciences Information Technology (LSIT) Global Institute are clear: trusted IT guidance is critically needed in the Life Science and Healthcare Industries.

This seminar is designed to address these top 4 areas of greatest need through case studies, identification of best practices, and discussions with industry experts. We sincerely hope to communicate with you, the various strategies, ideas, processes and risks that will help you be more effective in your company.

About Good Informatics Practices

The integration of IT into the life sciences and healthcare is rapid and profound. This integration has a real potential for reducing both the time and cost of bringing new medical products from discovery to the patient. The one main inhibiting factor is "trust". Trusting that these very complex IT tools, computational processes, and resulting data are in fact—accurate and scientifically valid throughout changes in Information technologies, is critical for all stakeholders and gatekeepers alike.

Trustworthiness and reliability will be established by weaving appropriate international IT standards in with best IT practices and applying detailed consideration to the special need of the life sciences and healthcare community. The resulting effort will produce GIP guidance publications which will be continually updated openly to the global community. These good informatics practices will become the playbook for trusted IT within Life Sciences.

The Need for GIP

GIP will be the catalyst for reducing barriers for adopting enabling technologies. Information Technology is a strategic component to the success of a company in today's competitive and complex environment. IT leaders, given a chance to have the basic, core requirements, standards, and compliance issues defined and addressed would then be free to implement IT solutions that are truly enabling the company to move forward efficiently, rapidly, and effectively.

The Underpinnings of GIP - What Makes GIP Sound and Usable?

GIP is built on a foundation of using the Risk Based Approach by a team of multi-functional, multi-talented experts who bring in holistic perspectives and critical thinking. GIP has never been done before in a public arena; therefore, the concept of starting from a green field allows LSIT to be innovative and creative while we seek out the best and most effective practices, as we diligently maintain a focus on quality, compliance, and practicality.

We believe GIP will create a definition of Trusted IT and deliver Trusted IT through addressing the complex environment of IT standards, processes, and issues that life science and healthcare companies face. By having one go-to source that is comprehensive for IT in any life science or healthcare environment will allow one to see the bigger picture. A comprehensive, transparent, and commonly accepted GIP will ensure Trusted IT.

About the Life Sciences Information Technology (LSIT) Global Institute

LSIT is a not-for-profit 501 c(3) who is pulling together the regulatory agencies, the standards institutes, and the healthcare and life science communities to drive change for earlier adoption of IT and compliance to critical processes and issues such as Part 11.

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

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.