About LSIT: The Purpose

Our purpose is to safeguard public health by increasing trust in Life Sciences and Healthcare information technology (IT) through the development of open, publicly available, best practice IT guidelines which will help organizations manage risk and adhere to optimal compliance standards.

We will achieve our mission by establishing ourselves as the trusted resource for Good Informatics Practices (GIP) Guidance. Our charter is to facilitate collaborations for developing open, publicly available GIP within the life sciences and healthcare communities.

Helping Support IT Leaders in the Life Science Industry

An IT Leader is constantly evaluating new technologies, seeking solutions to specific problems and needs, analyzing all things IT, while always scanning their departments and business units for trouble and maintenance that include:

• Downed systems, risk management, security
• Updates, patches, and upgrades
• Interdepartmental integration
• Capacity, performance
• Storage, allocation

IT leaders need answers to regulation questions:

• What do I need to do for regulation purposes?
• When do I need to ensure systems meet regulatory requirements?
• How do I communicate IT compliance to regulatory bodies?

Frustrated IT leaders might sense that they spend too much time and/or costs in reactionary mode, as opposed to developing strategies, and planning and deploying IT systems.

As a consortium of leaders from the full spectrum of life and health sciences, with experts working in: research, IT, business, systems, regulatory affairs, standards and more, LSIT provides solutions to these IT leaders in the form of the GIP.

Why LSIT?

• We are collaborating with regulatory agencies and standards bodies to effect change in our industry by clarifying the complexities of regulations and standards.
• We understand the critical nature of safeguarding IP assets. As most corporate informational assets reside within the IT architecture, it is critical that IT leadership be proactive about protecting the company's IP, trade secrets, and clinical data.
• Our strong network of professionals and leaders is highly proficient in the nuances of the various regulatory agencies. An IT leader must face compliance of over 40 global regulatory agencies and their directives including: Sarbanes Oxley, FDA Part 11, ISO, GxPs, NIST, EPA, and HIPAA. Increasingly, he or she will comply with regulations of the worldwide regulatory agencies as well.
• GIP is developing the first Good Informatics Practices Guidance Document (GIP) which will leverage best practices from over 55 world class experts to address the basic requirements and complexities of:
  • Regulations such as GxPs, 21 CFR 11, HIPAA, EPA, SOX, etc.
  • Standards such as NIST, IEEE, CMM, ITIL, SEI, QSR, CDISC, ISO, HL7, etc.

What does this mean to the IT Leader?

• The GIP document will become the comprehensive playbook, endorsed by regulatory bodies. It will address critical aspects in an IT environment from Security to Data Management, and Validation. CIO/IT Leaders will create solutions, replacing or improving current systems through a good informatics practice which will positively contribute to the company's bottom line
• Unique Life Science regulatory requirements will be addressed globally in a forum where everyone speaks the same language - communicating trust IT.
• Accelerating the development process from research to commercialization is the driving objective, and IT is the force that powers it.

Ultimately the CIO/IT Leader has three choices:

• Continuously scan the a disparate array of global resources for regulatory issues and best practices
• Spend vast amounts of resources each year to hire multi-disciplinary experts that combine regulatory affairs, IT/ engineering, and internal audits, to audit and manage IT compliance and standards, and train the teams
• Join LSIT and get first hand knowledge for immediate implementation