Good Informatics Practices

What is GIP?
The Good Informatics Practices Guidance Document (GIP) is a newly drafted comprehensive body of information of regulatory requirements in the form of existing (GLP, GMP, GCP and Part 11) and currently used standards compiled in one reference guide for an IT system of a life science or healthcare environment.

The Need for GIP
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. Today there is extensive additional work required by each IT system to achieve a "trust" level within an organization. Since there is no broad reference guide that is complete and focused for IT department / systems in life sciences and healthcare environments there is a critical need for an organization to develop this guideline.

Why is GIP critical?
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.

What difference will GIP make?
GIP will add value through helping company's progress to contemporary IT solutions. GIP will level the playing field where barriers such as security, validation and data management, for example, are complex, confusing and costly. If the five communities: Life Science Industry, Medical and Scientific Research, IT Industry, Government Regulators, and Healthcare Providers can reference such a Guide as GIP to develop consistencies in areas of Verification and Validation, QA, Security and Data Management, the ease for partnering, data sharing, mergers, integration, and FDA compliance would be tremendously improved. There is considerable cost savings with a resultant ROI clearly identifying the benefit of adopting GIP as a reference document.

GIP as best practices will come forth to benefit other areas such as research, marketing, sales and operations by freeing up IT resources to serve the strategic and tactical requirements of an organization. Better practices mean better quality systems throughout. Quality reduces risk and enhances the likelihood of success.

What is the Cost of not having GIP?
If we keep doing what we're doing, we'll keep getting what we're getting. For big pharma, banking on blockbusters are farther and fewer to come while with the FDA's mandate to move quickly has resulted in a backlog of approvals for submissions by sheer volume alone. It is expressed that the number of clinical trials will triple (3X) in the next 5 years...

The Life Science industry is struggling to contain costs and improve the drug development process timeline. IT as a strategic asset rather than a continuous series of reactionary events will serve to play a key role in achieving these goals. Adopting a GIP guideline will better position the industry and individual organizations to realize lower costs and reduced timelines for development. GIP will add value through helping companies transform into contemporary IT solutions, accelerating the time from discovery to commercialization.

It will create a level of consistency in processes and quality in IT that FDA and other regulatory agencies have come to expect with other guidelines, easing the audit/inspection experience for all.

It will develop a level of comfort that comes with clarity and understanding that consistent IT processes are in place and well understood by all those involved. Thus, IT systems will be progressive rather than piecing solutions together for the short term need.

For example, companies currently don't track the cost of validating a companywide IT system. They validate because they have to be compliant. If the validation process were streamlined and consistently done, with GIP there are significant costs savings and efficiencies to be realized. Additionally, GIP will keep a focus for helping IT align with the business strategies and goals. That alignment goes right to the bottom line.

Who is the user of GIP?
GIP is built by using a Risk Based approach chapter by chapter, sub-section by sub-section to address the needs and issues at the appropriate level of a life sciences company, who express different risks and needs by size and maturity from big pharma to device companies or small Biotechs.

The end user is any decision maker who has accountability for deployment of IT resources. In a Life Science or Healthcare organization typically a user will have approximately 10 years of IT experience and some knowledge of the regulated environments in life sciences.

This Guidance document will circumvent many global barriers (i.e. primarily legacy systems that cannot integrate, commercial software needing to be validated, security parameters needing to be defined), because of using the risk based approach. These are guidance that are best practices in any culture, any life science organization, and on any system. As they address appropriate needs at the appropriate level for the company.

One of the most serious concerns facing any Life Science or Healthcare organization is the retention, training and development of key knowledge workers. By adopting GIP, thus eliminating the need for constant reworking of existing or acquired systems, there is an increased utilization of in-house talent yielding more efficient training and retention of corporate knowledge.

About Good Informatics Practices (GIP)
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, 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 published and continually updated openly to the global community

Good Informatics Practices (GIP) is intended to be a version controlled series for the IT professional engaged in the life sciences and healthcare communities. Although initially the GIP series will be a broad overview of all IT issues in the life sciences and healthcare, this will serve as a base for further development into specific IT issues relating to specialty areas of the life sciences and health communities. As it evolves, the GIP series will cover medical research and the industrial life sciences sectors (pharmaceuticals, biologics, medical devices and diagnostics). Eventually the GIP series will also address the needs of the healthcare provider and payor with issues ranging from interoperability of data, images, information and the privacy of it all.

LSIT has begun building the foundation for this growth by developing a more generalized version that encompasses the global aspects of life sciences information technology. LSIT requires appropriate funding to develop this broad overview so as to initialize further development of the dependent and related specialty issues. LSIT will eventually develop GIP for the entire spectrum of the health and life sciences research enterprise, but this will be done from a perspective of a wide angle lens that speaks to the core fundamentals

About GIP and The Life Sciences Industry
The GIP publication will be released in version control series. It will eventually span the use of Information Technology (IT) throughout the life sciences and healthcare community. GIP will consist of both best IT practices and appropriate published IT standards. The goal of the publication will be to serve the IT, life sciences and healthcare communities and government regulators as a trusted reference source.

The initial GIP publication will be a high-level overview and broad in its scope and purpose. LSIT believes this will serve as a general reference guide to other specialty GIP publications.

Over time, the GIP series will address specialized use of the IT within various areas of the life sciences and healthcare community. This will include the medical research area and four main life sciences industrial sectors: pharmaceuticals, biologics, medical devices and diagnostics. Also the GIP series will address specific areas important to healthcare providers.

Click here for the GIP draft Table of Contents.

Click here for an example of the IT Spectrum of the Life Sciences.