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  A risk based approach to GxP Compliant Laboratory Computerized Systems in the COVID-19 Era and Beyond
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Laboratory Computerized Systems and data management operations are increasing in variety, sophistication and complexity in the GxP environment. Widespread reliance on these systems, along with their potential impact on data integrity, and the trend towards cost efficiency within companies, means that companies need achieve GxP compliance of laboratory computerized systems– within a reasonable budget and timeline.

The wide diversity of these systems, coupled with their capability for networking, makes it impractical and inefficient to have single approach to achieve GxP compliance for all systems. For example, a High Performance Liquid Chromatography (HPLC) with a Photo Diode Array (PDA) detector is much more complex than a pH meter, and will require a correspondingly more detailed and complex implementation, control and maintenance approach.

Poor management of laboratory computerized system acquisition, implementation and operation may result in:

  • Failing to meet process and user requirements
  • Unacceptable cost or time overruns
  • Risk of non-compliance
  • Data Integrity issues
  • On the other hand, there are major business benefits to both regulated organizations and suppliers, in delivering systems that defined and specified and are easier to support and maintain. Benefits include:
  • Reduction of cost and time taken to achieve and maintain compliance
  • Early defect identification and resolution leading to reduced impact on cost and schedule
  • Cost effective operation and maintenance
  • Effective change management and process for continual improvement
  • Enabling of innovation and adoption of new technology
  • Providing frameworks for user / supplier co-operation
  • Assisting suppliers to produce required documentation
  • Promotion of common, consistent, system life cycle, language and terminology
  • Providing practical guidelines and examples
  • Promoting pragmatic interpretation of regulations

Learning Objectives

This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation by:

  • Examining the system life cycle and its applicability for most laboratory computerized systems
  • Identifying characteristics that distinguish various types of laboratory computerized systems
  • Developing a rationale for scaling activities and effort based upon risk, complexity, and novelty
  • Defining a strategy for supplier assessments, and the effective leveraging of supplier knowledge, experience, and documentation
  • Applying the GAMP® 5 Quality Risk Management (QRM) approach
  • Defining necessary operational and maintenance activities
  • Recommending an approach to system retirement
  • Leveraging deliverables and activities for very similar or identical systems


DAY 01(11:00 AM - 5:00 PM EST)

  • 11.00 AM: Session Start
  • Lecture 1: Introduction and Background
  • Introductions / Participants’ Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)
  • Background
  • Industry Context
  • Key Concepts
  • Lecture 2: Quality Risk Management
  • Science Based Quality Risk Management
  • Quality Risk Management Process
  • Initial Risk Assessment
  • Implement & Verify Appropriate Controls
  • Review Risks & Monitor Controls
  • Lecture 3: Life Cycle Approach
  • Computerized Systems Life Cycle
  • Specification & Verification
  • Computerized System Validation Framework
  • Lecture 4: Life Cycle Phases
  • Concept
  • Project
  • Operation
  • Retirement

DAY 02(11:00 AM - 5:00 PM EST)

  • Lecture 5: GxP Compliance
  • Data Integrity
  • Security
  • Defining Electronic Records and Raw Data
  • Lecture 6: Risks & Implementation of Systems
  • Simple Systems (Analytical Balance,pH Meter, Electronic Pipette)
  • Medium Systems (LIMS / ELN)
  • Complex Systems (Robotics)
  • Lecture 7: Supplier Documentation & Services
  • System Development by the Supplier
  • Supplier Assessment
  • Supplier Good Practices
  • Leveraging Supplier Knowledge & Documentation
  • Quiz: Jeopardy!!!!
  • GxP Compliant Laboratory Computerized Systems

Who will Benefit

  • Lab Director
  • Lab Scientists
  • Computer Validation Professional responsible for defining and managing laboratory computerized systems in regulated life science industries
  • Information Technology (IT) personnel
  • IT support services
  • Management and Laboratory System users
  • Software Developers
  • Suppliers of Computerized systems including suppliers or:
  • Software
  • Hardware
  • Analytical instrumentation
  • System integration services
  • IT support services
  • Regulators


  • Pharmaceuticals
  • Biotech
  • Medical Device
  • Radiological Health
  • Blood Products
  • Companion Animals
  • Food
  • Cosmetics
  • Tobacco
  • Academia

FDA Faculty Carolyn Troiano

Faculty Carolyn Troiano

Award winning FDA Compliance Expert for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.