Data, Information and Knowledge - An overview presentation covering for production, laboratories and QA. Link to regulations e.g,
- Data, information and knowledge
- US GMP regulations: 211.68(b), 211.180(d), 211.188 and 211.194(a-e): complete data and complete information
- EU GMP Chapter 4 regulations – raw data principles outlined from a GMP perspective
Cutting Through the Confusion and Fog of Regulatory Terms
Currently there are many terms used in GMP regulations and data integrity guidance documents. What do they mean? How are they relevant to debate? Definition and interpretation of
- Original record / record
- Raw data – MHRA GMP and US GLP definitions
- Data and metadata
- True copy
- Complete data
- Initial data
- Translating raw data for a GMP environment: should we treat manufacturing and laboratory the same when it comes to raw data?
Interpretation of Raw Data for Production Systems
Using a manufacturing process that is automated by standalone PLCs, PLCs linked to a SCADA system and an automated Manufacturing Execution System, what constitutes raw data will be outlined.
- Raw Data for PLCs
- PLCs linked to a SCADA system
- SCADA linked to a Manufacturing Execution System
Interpretation of Raw Data for Laboratory Systems
Using a process involving a chromatography data system and a LIMS, what constitutes raw data will be outlined in two scenarios
- Hybrid CDS and manual input to the LIMS
- Electronic CDS with automatic transfer to the LIMS
- Managing sample management and preparation records
Workshop: Defining Raw Data for Production, QA and Laboratory Systems
This workshop is intended to reinforce the two previous presentations. Attendees will be given laboratory, quality assurance and production scenarios to define raw data. Outputs will be discussed with the course
Can a True Copy be Raw Data?
- This brief presentation will start from the definitions of raw data and true copy and explore if and how a true copy can be considered raw data.
Workshop : What are Raw Data for quality decisions
- Identifying GMP quality decisions?
- For each quality decision – define the raw data