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Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Dr Bob McDowall, McDowall Consulting, UK
These two new courses have the following objectives:
The learning objectives are firstly, understand the data integrity requirements of a GMP regulated laboratory in Pharmaceutical organisations and contract labs and secondly, how laboratory personnel can ensure compliance and be able to defend their positions. Records generated by three processes will be taken through the presentations and workshops: paper only with records maintained in a laboratory notebook or controlled sheets, hybrid system with signed paper records with underlying electronic records and an electronic system using electronic signatures.
The auditing course will develop the understanding of what is required for a data integrity audit of a laboratory computerized system and then develop the principles, based on workshops and discussions, of how to audit hybrid and electronic laboratory systems The scope of auditing a system for data integrity will be developed during the course along with a risk based prioritisation of the key areas to focus audit attention on. The attendees will audit one computerized system and then feedback the audit findings to the laboratory manager and business process owner.
Note that this course will focus only on hybrid and electronic systems and will not consider paper-based data integrity.
Data Integrity is currently a major concern with both the FDA and European Regulatory Agencies. Several FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally. The regulatory concern has been responded by the FDA issuing Compliance Program Guide (CPG) 7346.832 that covers Pre-Approval Inspections. This document became effective in May 2012 after Agency inspectors received training in data integrity where they focus on computer systems and not the paper output. The CPG objective 3 covers the laboratory data integrity audit. Furthermore in August 2014, the FDA issued Level 2 guidance on their web site about the sharing of login credentials for computerized systems and the use of test injections for testing into compliance.
In Europe, the UK’s MHRA in December 2013 gave notice to regulated users to begin conducting data integrity audits of their own systems and those of their suppliers from the beginning of 2014. Similar to the FDA, European Inspectors have also undergone training in data integrity. The UK has also gone further by writing to the major suppliers of chromatography data system software requesting copies of the application and documentation to that the MHRA can understand how they operate and how falsification could occur.
As the regulators are tightening their inspection approaches it is important that managers, supervisors and users in regulated GMP laboratories understand the issues around data integrity. In March 2015, MHRA issued an updated Data Integrity Guidance containing an expansion of the expectations of data integrity governance together with a list of 19 definitions and expectations for each one.
Course 1 focuses on three types of record that can be found in analytical laboratories working to GMP: paper, hybrid computerized system and electronic workflows with electronic signatures. Through presentations, workshops and discussions attendees are taken through the process from analysis to generation of results to understand data integrity issues.
Course 2 takes the principles from the earlier course and develops them to enable attendees to be able to conduct effective internal audits or self-inspections of either hybrid or electronic systems in compliance with EU GMP Chapter 9. This is achieved mainly via a series of interlinked workshops with a few presentations. This course will focus only on hybrid and electronic systems.
These courses will be of significant value to:
Managers and scientists from Quality Control and Analytical Development Laboratories wanting to understand the data integrity and audit process
Quality Assurance personnel
Contract Research Organisation and Contract Manufacturing Organisation laboratory and QA personnel
Auditors (internal and external) responsible for assessing laboratory quality and data integrity
Programme Course 1:
Establishing the Controls for Ensuring Laboratory Data Integrity
EU and FDA GMP Regulations Impacting Laboratory Data and Results
EU GMP requirements
MHRA Data Integrity Guidance
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
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
Recording of Data
Paper based systems
Hybrid systems with paper printouts and electronic records
Stand alone systems containing only electronic records
Networked systems containing only electronic records
Recording of Data
Audit of an analytical record
Scenarios covering paper based record, a hybrid system and an electronic system
Converting laboratory data to information
Identifying and handling errors on paper as well as electronic systems
Calculations performed manually and by computer programs
Issues with truncation and rounding of numbers
Integrity and security issues of the records generated during transformation
Using Excel correctly
Data from printout transcription, rounding, truncation
Collation and Reporting Results
Calculating the reportable value and comparison with the specification
Paper processes versus electronic processes
Linkage with out of specification investigations (OOS)
Key Learning Points and Final Discussion
Programme Course 2:
Self Inspections and Audits to Confirm Effective Data Integrity Controls
Introduction to Course 2 & Key Learning Points from Course 1
Data integrity concerns of regulators:
FDA warning letter and EU non-compliance concerns about data integrity
FDA Compliance Program Guide 7346.832 for PAI
MHRA requirement for self inspections to focus on data integrity
Role of management in ensuring data integrity
Key learning points from Course 1
Identifying the Laboratory Controls to Audit for Electronic and Hybrid Systems
Group work with facilitated discussion to take the data integrity cycle and establish the controls required at each stage
This establishes what could be covered in a data integrity audit
Risk Assessment and Prioritisation
The data integrity cycle with the audit objectives developed in Workshop I will be applied to one of three systems (hybrid and electronic systems) to obtain a risk based approach to auditing
FDA Key Laboratory Data Integrity Concerns
Using some real FDA warning letters the teams will cross check that the output of Workshop II is congruent with the FDA concerns around laboratory
Attendee validation of an updated audit list
Pulling it All Together
Based on many years of the teaching team’s laboratory experience, presentation of their top 10 non-compliances based on FDA and EU regulations and audit experience will be given
There will be an opportunity to discuss and compare the output from Workshop III against this knowledge base and experience
Preparing for the Data Integrity Audit
Based on the selected scenario the attendees will determine the preparation needed for a laboratory audit
Feedback and discussion with the teaching team
Observations and Findings During a Laboratory Audit and Planning the Closing Meeting
Each teams will be provided with an audit of a laboratory with observations
Teams will determine if there are any data integrity non-compliances with the regulations and laboratory procedures
Teams will determine if any observations are findings (non-compliances) and grade the severity of each one
Prepare for the closing meeting with the Head of the Laboratory and the business process owner of the systems
Feedback to the Auditees
Teams will present the audit conclusions and the findings to the Head of the Laboratory and the business process owner of the systems
Discussion with the auditees of the findings
Review of the Course and Key Learning Points