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In-house Training Programme

Requirements for Data Integrity in GMP Laboratories

Time Content
09.00 h 0. Introduction to Course and Instructor
  • Outline of the day
  • Set expectations and introduction to the trainer
09.15 h 1.Why is Data Integrity Important?
  • Able Laboratories fraud case 2005
  • Rewriting Compliance Program Guide 7346.832 for Pre-Approval Inspections
  • US and EU: Complete data and raw data requirements
  • Data Integrity Training for FDA Inspectors: summary of the training
  • Inspection of computerised systems is changing: paper to on-line
  • Summary of recent company warning letters dealing with data integrity
  • MHRA approach to data integrity and internal audits
  • GAMP SIG for data integrity
  • The need for a data integrity plan
10.15 h 2. Role of Management in Data Integrity
  • Role of Senior and Laboratory Management in ensuring data integrity or promoting data falsification and fraud
  • Failures to address poor data integrity practices and no training
10.45 h Break


11 h 3. Principles of Data Integrity
  • The ALCOA+ criteria for data integrity
  • Paper versus hybrid versus electronic systems
  • Scope: production information versus laboratory data: why are laboratory data higher risk?
11.45 h 4. US 21 CFR 211 and EU GMP Chapter 4: Complete data v raw data
  • Why complete data and raw data are important for understanding data integrity
  • EU GMP Chapter 4 requirements for raw data
  • 21 CFR 211 requirements for laboratory records: complete data
  • FDA Level 2 guidance: paper versus e-records
  • Complete data / raw data example for a CDS
12.30 h Lunch


13.30 h 5. Ten Compliance Commandments for Laboratory Systems
  • Outline of the 10 key areas for data integrity
14.15 h 6. Facilitated Discussion / Workshop on Key Data Integrity Topics
  • Recording results on paper
  • Configuration of software applications
  • Unique user identities for all users
  • Unauthorised access
  • Appropriate access privileges for each user role
  • Is my chromatographic system ready? Role of “test” injections
  • Audit trails – options for older systems
  • Standalone versus network systems
  • Protecting electronic records of standalone systems
15.30 h Break (may be taken earlier with the long data integrity topics discussion)


15.45 h 7. Workshop: Developing a Data Integrity Plan
  • Key requirements for a data integrity plan and procedure
  • Prioritise systems: select one or two systems to take through process
  • Remediate, retire or replace?
  • Resources and management backing
16.45 h 8. Key Learning Points and Final Discussion
  • Summary of Data Integrity Requirements
  • Final Discussions
This training course is also available for two days.

GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.


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