Sprecher
Dr Christopher Burgess, Chairman of the ECA Analytical Quality Control Working Group
Dr Bob McDowall, Member of the ECA IT Compliance Interest Group
Zielsetzung
These two 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. Second person review is a critical process that needs to be thorough and effective to ensure that data issues are picked up and resolved.
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 mainly 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. In preparation for the final sessions there will be workshops dealing with specific data integrity topics. At the end, attendees will read the laboratory audit report, determine if there are any findings and classify them. Then feedback selected audit findings to the quality control manager and head of quality assurance.
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.
Hintergrund
Data Integrity is currently the 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. In April 2016 a draft data integrity guidance was issued for industry comment.
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. Followed in July 2016 by a more general guidance for GXP data integrity.
In June 2016, the World Heath Organisation issued a final version of a guidance document which provides a more encompassing explanation of data integrity and also data governance expectations for regulated healthcare companies. EMA and PIC/S both issued draft data integrity guidance documents in August 2016. ECA have published two versions of Data Governance and Data Integrity guidance in 2016 and 2018. The GAMP Forum have published a Guide on Records and Data Integrity in 2017 and the first of three Good Practice Guides on Data Integrity - Key Concepts. Lastly, PDA have also issued a guidance document for pharmaceutical laboratories in August 2018.
The emphasis of all regulators 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.
Zielgruppe
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
Programm
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“
- Observational tests and instrument tests
- Training of staff
- Qualified analytical instruments and validated software
- Integrity issues
- Application of ALCOA+ principles
What are the requirements for raw data integrity?
Three scenarios covering
- a paper system
- a hybrid system
- a client server electronic system
- 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)
- Reviewing an analytical record
- Scenario covering paper based record and an electronic system
- 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?
- Application of ALCOA+ principles for the review of paper records
WORKSHOP IV: Data Review – Electronic Records
- Application of ALCOA+ principles for the review of electronic records
End of Course 1 / Registration for Course 2
Programme Course 2:
Self Inspections and Audits to Confirm Effective Data Integrity Controls
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
- 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
- Working in teams, attendees will analyse FDA warning letters to understand the regulatory concerns.
- Discuss and feedback session
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
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
- 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 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
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?
- 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
- 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
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