Good Informatics Practices (GIP)

GIP: Fueling the Life Sciences Innovation Engine
Good Informatics Practices (GIP) is an implementable IT system and process guidance for life sciences executives, technology practitioners and auditors designed to optimize and build a trusted IT ecosystem. Gain actionable information on how to efficiently…and cost-effectively bring trusted medical products to market.

Harness the transformational value of IT within your organization with GIP modules available at the HIMSS eBookstore

What is GIP?

Good Informatics Practices (GIP) is a proven methodology for aligning IT governance with institutional governance. The GIP Guidance is a comprehensive resource for implementing a trusted IT ecosystem for ensuring the reliability and effective use of critical health data. The Guidance includes regulatory requirements (e.g., GLP, GMP, GCP and Part 11), standards, best practices and case studies. It also has practical tools such as sample documents, check lists, standard operating procedures, methodologies and specific best IT practices used by life sciences executives, senior management, technology practitioners, and auditors.

The Need for GIP

In a highly regulated and competitive industry like life sciences, ensuring the reliability and privacy of data and information systems is critical for medical product development. HIMSS GIP addresses the challenges of transformational value of information and communications technologies (ICT) that link medical product development to healthcare providers and patients.

This body of knowledge promotes standardization of IT systems and processes used across the life sciences industry. This in turn, ensures that product quality and individual privacy are uncompromised in the development of medical products. As life sciences companies engage in R&D and share pre-clinical safety testing and related data with providers, HIMSS GIP helps avoid costs and process redundancies currently required to validate data from different departments and outside organizations.

GIP Brings Value

As the healthcare and regulatory landscapes continue to change, the body of knowledge contained in HIMSS GIP reference tools enables companies, regulatory agencies, and the healthcare providers to trust the IT business processes that impact medical product quality. HIMSS Life Sciences GIP is built on Risk Based Approach (RBA) and Quality By Design (QbD), scaled in direct proportion to risks to human health and public safety.

Adherence to GIP will increase the standardization of IT systems, ensuring the accuracy and reliability of the healthcare data in the life sciences sector. In addition, GIP offers a body of knowledge that acts as:

  • A tool for senior IT executives and directors involved with strategic planning initiatives and business development
  • A resource for IT professionals and analysts
  • A method for building IT processes, good governance and effective regulatory compliance into organizations
  • A guide for CFOs struggling with IT budgets
  • A reference for a variety of roles within organizations in which productivity depends on effectively and efficiently accessing IT tools and data artifacts

Beneficiaries of GIP

GIP is intended be used by the decision makers such as the CIO, CFO and/or COO who are driving IT budgets and planning. It will also benefit any person or company managing or using IT while performing business services within organizations governed and regulated by domestic and international government agencies and ministries whose prime purpose is to protect public health. The interested audience may include:

  • Life Sciences Industry Senior Management in Strategic Business Development
  • Life Sciences Industry Technology Practitioners
  • Auditors and Regulators
  • Internal Quality Organizations

Additionally, GIP will bring value to those in other disciplines, who work on any sort of IT system and have compliance responsibilities, which could include disciplines in: Quality Assurance, Regulatory Affairs, Verification & Validation, Security, Data Management, Project Management, Qualification, and Clinical Affairs.

Scope

GIP will address the most prominent areas of IT systems and practices for a health or life sciences organization globally. GIP is a body of knowledge encapsulated into modules that include the topics of Data Management, Infrastructure, Risk Management, Security, Training Practices, and Verification & Validation. Each module aggregates best practices in managing computer systems. Modules contain citations to the applicable federal regulations, references to appropriate standards, use cases and case studies, as well as employable tools such as sample documents, check lists, standard operating procedures, methodologies and specific best IT practices.

Additional Information and Resource

The following resources provide additional information about GIP:

Obtaining GIP Modules

To obtain your copy of a GIP module, please visit the Good Informatics Practices category of the HIMSS eBookstore, or click below: