Lab Data Integrity, Part 2 Self Inspections and Audits to Confirm Effective Data Integrity Controls

15-16 June 2016

Prague, Czech Republic

Course No 15528

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Speakers

Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Dr Bob McDowall, McDowall Consulting, UK

Objectives

These two new courses have the following objectives:

Course 1:
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.

Course 2:
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.

A checklist will be provided to all attendees for the auditing of computerised systems for data integrity.

Note that this course will focus only on hybrid and electronic systems and will not consider paper-based data integrity.

Background
Data Integrity is currently a major concern with both the FDA and European Regulatory Agencies. Many 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.

Background

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. European Inspectors have also undergone training in data integrity. As the regulators are tightening their inspection approaches it is important that managers, supervisors and users in regulated GMP laboratories understand the issues concerning data integrity within the GMP regulated laboratory.

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. In September 2015, the World Heath Organisation issued a draft guidance document which provides a more encompassing explanation of data integrity and also data governance expectations for regulated healthcare companies. In 2016, the FDA is also expected to issue a guidance for industry on Data Integrity Questions and Answers.

The emphasis of both MHRA and WHO is on the ALCOA principles to outline regulatory expectations for ways to ensure the integrity of data over the life cycle. This is reflected in the way the two courses will be presented.

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.

Target Group

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

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 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
Security 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

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
Application of ALCOA+ principles

WORKSHOP II:
Recording of Data
Audit of an analytical record
Scenarios covering paper based record, a hybrid system and an electronic system

Transforming Data
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
Application of ALCOA+ principles

WORKSHOP III:
Data Transformation
Application of ALCOA+ principles to
Paper process
Hybrid system

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)
Application of ALCOA+ principles

Key Learning Points and Final Discussion

End of Course 1 / Registration for Course 2

Programme Course 2:
Self Inspections and Audits to Confirm Effective Data Integrity Controls

Introduction to Course & Key Learning Points from Course 1
Data integrity concerns of regulators
FDA Compliance Program Guide 7346.832 for PAI
MHRA and WHO data integrity guidance documents
Role of management in ensuring data integrity
Key learning points from Course 1

Data Integrity Self Inspections and Audits for Hybrid and Electronic Systems
Data integrity audits of computerised systems
Understanding the data life cycle of the system to be audited
Validated system can have data vulnerabilities
Presentation and discussion of the data integrity audit checklist

WORKSHOP I: Risk Assessment and Prioritisation
So much to do but so little time – risk management in practice
When conducting a data integrity audit which areas within a pharmaceutical quality system will be the focus?
Feedback and discussion with the teaching team

WORKSHOP II: Auditing Spreadsheets
Working in groups attendees will be given a printout of a spreadsheet
What questions need to be asked to determine if there is sufficient data integrity and control?
Feedback and discussion with the teaching team

WORKSHOP III: Hybrid Systems Auditing
A laboratory system is used in hybrid mode
What questions should the auditor ask to determine if there are any data integrity problems?
Feedback and discussion with the teaching team

WORKSHOP IV: Audit Trail of Electronic Systems and Electronic Signature Auditing
Review of audit trail entries is a key data integrity requirement of Annex 11
Attendees will review the printout of an audit trail to determine if there are any data integrity issues to be raised?
Use of electronic signatures can mask some data integrity issues
Can the attendees find what those issues are?
Feedback and discussion with the teaching team

WORKSHOP V: Preparing for the Data Integrity Audit
In the first of three linked workshops, attendees will be given a laboratory scenario to answer the following questions:
What will be the composition of the audit team?
What will be their skills?
What will be the duration of the audit?

WORKSHOP VI: Observations and Findings During a Laboratory Audit and Planning the Closing Meeting
Each team 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

WORKSHOP VII: 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

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