Webinar on Integration of Enterprise Requirements Planning (ERP) and Legacy FDA-Regulated Systems
This webinar will benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
- (1888PressRelease) October 19, 2016 - We will discuss the importance of applying industry best practices when planning, executing and validating the integration of a laboratory system (Laboratory Automation System (LAS), Laboratory Information Management System (LIMS), eNotebook, etc.) with a business system, such as an ERP or similar type of enterprise or supply-chain automation system. These are commonly integrated in manufacturing companies that use large-scale, enterprise-wide solutions for automating the production, testing and distribution processes in pharmaceutical, biotechnology, medical device or other related FDA-governed industries, and rely on data from laboratory systems to feed information about product quality and/or release.
Typically, any laboratory system in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process) must be validated in accordance with FDA guidelines for computerized systems. By integrating such a system with a business system, the business system must also comply with FDA's requirements for validating the laboratory system. Otherwise, the "clean" laboratory system would be tainted by the "dirty" business system.
In addition to validation considerations, security must also be evaluated. Any data that resides on the laboratory system that must be kept confidential or secured in some way must continue to be treated the same way once integrated with a business system. Those users accessing the business system must also not be able to enter or alter data directly into the laboratory system, unless it is clearly a requirement based on the process being followed. There should be a distinct segregation of duties, as well, meaning all best practices for ensuring that the person responsible for entering data is not the person responsible for reviewing and/or approving the data.
Areas Covered in the Session :
-Gain an understanding of laboratory system computer validation planning, execution and management concepts, and how these efforts apply to any integrated business system
-Discuss the best practices necessary to develop an integrated laboratory and business data collection, analysis and reporting computer system validation program
-Identify the key input and output points that will warrant greater scrutiny as the integrated system is tested and validated
-Discuss the steps for validating systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs
-Learn how to leverage these practices across all systems by creating a standardized program for integrating FDA-regulated and non-regulated systems
-Understand the additional training that must be provided to business and IT staff involved in the integration process
-Discuss the communications necessary to maintain all integrated systems in a validated state, as required, as any changes are made to subsystems or components
-Interactive Q&A Session
Who Will Benefit:
-Information Technology Analysts
-Information Technology Developers and Testers
-QC/QA Managers and Analysts
-Compliance and Audit Managers
-Computer System Validation Specialists
-GMP Training Specialists
-Business Stakeholders/Subject Matter Experts
-Business System/Application Testers
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