Programme Part 1
Establishing the Controls for Laboratory Data Integrity
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
WORKSHOP III: Data Review of an Excel Template
Collation and Reporting Results
- 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 IV: Paper, Hybrid and Electronic Reporting Processes
- Discussion of the strengths and weaknesses of reporting processes