Press Release

LSIT Executive Briefing

Contacts:

San Diego, California, USA, October 24, 2006 -- On October 20, 2006, the Life Science Information Technology (LSIT) Global Institute held an Executive Briefing for its board members and volunteers. The purpose of this meeting was to give an update of the progress in developing the Good Informatics Practices (GIP) Guidance Document that will serve as a reference guide of regulatory & standards requirements for life science or healthcare organizations. This GIP Guide involves the collaboration of governmental regulatory agencies, life science companies such as big pharmaceuticals, biotechs and medical devices as well as medical research organizations and Academia.

The Good Informatics Practices Guidance Document (GIP) is a comprehensive body of information of regulatory requirements and currently used standards pulled together in one reference guide for an IT department of a life science or healthcare environment.

Similar Guidance Documents have been developed addressing federal regulatory requirements by the U.S. Food and Drug Administration (FDA) in such references as: Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and the Code of Federal Regulations (CFR), Part 11.

The need for GIP is great and continues to grow as IT vendors bring out faster and more comprehensive technology solutions serving the life sciences and healthcare communities. All functions within a life science organization require significant use of multiple IT platforms. Their intellectual property, knowledge management, and data are on IT systems that must be trusted and secure. There is no other broad Guidance that is complete and focused for IT departments in life sciences and healthcare environments.

The Executive Briefing went on to present the use of a Risk Based Analysis to address the growing issues in such areas as: Security, IT/Enterprise Infrastructure, and Verification & Validation. The Risk Based approach is going to be used for all 16 chapters that will make up this Guidance Document. This approach is used to decipher the level of exposure or vulnerability that might present for the company and develop a process that is appropriate to the level of need for the company. Risk assessment, is a practice of identifying factors that can negatively influence a function. In the case of any life science or healthcare organization the first measure of risk is to the patient, where human lives and their health and safety are assessed and regulated in every step of the way.

Barbara Nollau, Executive Consultant with Global Life Sciences, gives an example of the variability of risk in two IT functions where the level of rigor or mitigation goes up with the level of impact:

A case in point is a patient's clinical data which has many regulations including HIPAA for controlled access and data management policies.

In a regulatory agency such as FDA they rely more and more on companies using a Risk Based approach. FDA's, Douglas C. Throckmorton, MD, Deputy Director, Center for Drug Evaluation and Research, states that in "[In current] [Cgmp] there are guiding principles that include: Science-based policies and standards, Risk-based orientation, integrated quality systems orientation, international cooperation, and strong public health protection." These are all focus areas and points for collaboration within GIP.

GIP Guidance that uses a Risk Based approach will allow appropriate levels of process and detail to each situation of an IT function.

About LSIT Global Institute:
The LSIT Global Institute is a not-for-profit organization, whose members will become an alliance from: Life Sciences Industry, Information Technology Industry, Academia, Research Institutes, Healthcare providers, and Regulatory Agencies. The LSIT invites specialty standards bodies to participate and contribute to GIP Guidance. The Institute's mission is to facilitate collaborations that create open, publicly available Good Informatics Practices (GIP) for the Life and Health Sciences community, and accelerate improvements in global public health. This is achieved by weaving appropriate international IT standards in with IT best practices and applying detailed consideration to the special needs of the life and health sciences community.
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