Part 1: The learning objectives are firstly, understand the data integrity requirements of a GMP regulated laboratory in Pharmaceutical organisations and contract labs from sampling to reporting. 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.
Part 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.
Background
Data Integrity continues to be the major concern with both 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 FDA issuing three versions of Compliance Program Guide (CPG) 7346.832 that covers Pre-Approval Inspections in 2010, 2019 and 2022. The latest version extends the objectives to include Quality in Pharmaceutical Development. Since 2015, various regulatory authorities have published data integrity guidance documents e.g.
MHRA: 2 versions of a GMP guidance in 2015 and a GXP guidance in 2018
WHO: two guidance documents in 2016 and 2021. The 2016 version is more comprehensive and contains the best description of ALCOA criteria in any regulatory guidance.
FDA: issued an interpretation of CGMP about data integrity in a Q&A format in 2018
PIC/S: published their final version of PI-041 guidance in 2021 and FDA: issued a draft guidance for Remote Interactive Investigations in 2023
Moreover, EU GMP Annex 11 for computerised systems and Chapter 4 on documentation are being updated to enhance the requirements for data Integrity. Industry bodies have also been active with the GAMP Forum publishing a Records and Data Integrity Guide in 2017 and three Good Practice Guides. APIC and PDA have issued guidance documents on the subject.
Finally, ECA have issued the 3rd Edition of a Data Governance and Data Integrity Guide that delegates will get a free electronic copy of.
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.
Part 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, work- shops and discussions attendees are taken through the process from sampling to generation of the reportable value to understand data integrity issues.
Part 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.
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
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Data Governance, Integrity & Quality, Regulations and Guidance
Summary of EU and FDA GMP requirements
MHRA, PIC/S and WHO Data Integrity Guidances
FDA Guidance documents OOS, Inspection of QC labs
Inspection findings 483 and warning letters
Defining data integrity, “complete data” and „raw data“
Analytical Process Mapping and Where Are the Vulnerabilities
Essential to map the process and identify all steps for traceability
SOPs, analytical procedures & training of staff
Internal and external auditing support
Identifying data and the controls to ensure integrity
WORKSHOP I: Assessment of an Analytical Process for Data Integrity Vulnerabilities of a Pharmacopoeial Loss on Drying Assay Presented with a pharmacopoeial Loss on Drying (LOD) analysis attendees identify any data vulnerabilities in the process
Role of Sampling in Ensuring Data Integrity
Why is proper sampling the key to ensuring the integrity and reliability of analysis?
What are the key features of sampling?
Principles for the Generation of Data
Qualified analytical instruments and validated Software
Recording observational tests and instrument/system tests
Identification of key vunerabilities
Application of ALCOA++ principles
WORKSHOP II: Generation of Data
What are the requirements for raw data integrity?
Three scenarios covering:
a paper System
a hybrid System
a networked electronic System
Processing and Reporting of Data
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)
WORKSHOP III: Processing and Reporting of Data
Reviewing an analytical record
Scenario covering paper based record and an electronic system
Reviewing Data and Collating Records
Identification and correction of errors for paper and electronic systems
Do you have complete data?
WORKSHOP IV and facilitated Discussion: Reviewing analytical records; Do we have to check everything? Using technical controls to aid the Reviewer
WORKSHOP V: Data Review of an Excel Template Application of ALCOA+ principles for the review of paper records
Second Person Review including Audit Trail Review
Role of the second person review
Determination that the reportable result is correctly calculated
Identification and correction of errors for paper and electronic systems
Facilitated Discussion: Reviewing audit trails by exception
WORKSHOP VI: Facilitated Discussion
Paper, Hybrid and Electronic Reporting Processes
Discussion of the strengths and weaknesses of reporting processes
Key Learning Points and Final Discussion End of Part 1 / Registration for Part 2
Programme Part 2:
Introduction to the Course
Data Integrity Self Inspections and On-Site and Remote Audits of Hybrid and Electronic Systems
Observations and findings
Remote audits: practicalities, limitations and Problems
Overview of the FDA Draft Guidance on Remote Interactive Evaluations 2023
WORKSHOP VII: 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 VIII: Audit of an Excel Spreadsheet
Attendees will be given an example of a spreadsheet
What questions need to be asked to determine if there is sufficient Data Integrity and control?
Feedback from the teaching team
WORKSHOP IX: Auditing a Hybrid Standalone System
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 X: Auditing a Networked Laboratory System – Audit Trail Review
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?
Can the attendees find what those issues are?
Feedback and discussion with the teaching team
WORKSHOP XI: Electronic Signature Auditing
Use of electronic signatures can mask some Data Integrity issues
Can the attendees find what those issues are?
Feedback from the teaching team
WORKSHOP XII: 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 XIII: 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 XIV: Feedback to the Auditees
Teams will present the audit conclusions and the findings to the Head of the QC Laboratory and the business process owner of the Systems
Discussion with the auditees of the findings
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
Testimonials
Seminar Programme as PDF