A risk based approach to GxP Compliant Laboratory Computerized Systems

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

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

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