Part 1: Establishing the Controls for Ensuring Laboratory Data Integrity
EU and FDA GMP Regulations Impacting Laboratory Data and Results
- EU GMP requirements
- MHRA and WHO Data Integrity Guidances
- FDA GMP requirements
- FDA Guidance documents OOS, Inspection of QC labs
- Inspection findings 483 and warning letters
- Defining Data Integrity, “complete data” and „raw data“
Principles for the Generation of Data
- Observational tests and instrument tests
- Training of staff
- Qualified analytical instruments and validated software
- Integrity issues
- Application of ALCOA+ principles
WORKSHOP I: Generation of Data
- What are the requirements for raw data integrity?
- Three scenarios covering
- a paper system
- a hybrid system
- a client server electronic system
Processing and Reporting of Data
- Paper / hybrid based systems
- Networked systems with electronic records and signatures
- Calculations and transformation of data manually and by computer applications
- Application of ALCOA+ principles to the process
- Calculating the reportable value and comparison with the specification
- Paper processes versus electronic processes
- Linkage with out of specification investigations (OOS)
WORKSHOP II: Processing and Reporting of Data
- Reviewing an analytical record
- Scenario covering paper based record and an electronic system
Reviewing Data
- Role of the second person review
- Determination that the reportable result is correctly calculated
- Identification and correction of errors for paper and electronic systems
- Do you have complete data?
WORKSHOP III: Data Review – Paper Records
- Application of ALCOA+ principles for the review of paper records
WORKSHOP IV: Facilitated Discussion
Paper, Hybrid and Electronic Reporting Processes
- Discussion of the strengths and weaknesses of reporting processes