2018 - Ensuring Integrity and Security of Laboratory Data

Eight key FDA/EU requirements for integrity and security of laboratory data
How FDA inspectors check integrity and security of data
Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters?
The importance of limited access to 'individual users' rather than to groups
FDA compliant definition, acquisition, maintenance and archiving of raw data
Critical integrity and security issues during the entire life of laboratory data: from data acquisition through evaluation to archiving
Examples how to ensure and document data integrity
Documenting changes of laboratory data: paper, hybrid systems, electronic
The importance of electronic audit trail to document data integrity
Review of electronic audit trail: who, what, when and how
Ensuring timely availability through validated back-up and archiving
Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions