Conference Posters - 2019

Embracing Technology to Ensure Quality in Organisations which both Sponsor and Host Research Brendon James & Dr Nick Morley, Royal Cornwall Hospital Trust

As an organisation which both hosts and sponsors research, we have developed electronic software to capture and collate findings from audit and monitoring reports to identify and respond to weakness in the systems and processes. The Quality Assurance Database (QuAD) is an innovative, purpose built, electronic system designed to facilitate audit and monitoring of research projects which are conducted in accordance with the principles of good clinical practice.

QuAD The Quality Assurance Database

Site or Sponsor develops audit plan to address weakness

Sponsor performs monitoring visits

Report or just findings captured in Quad Findings from multiple reports collated to identify weakness and system failures Site and Monitor address the findings  Whilst eliminating the need for paper files the most significant benefit of the database is that it provides the sponsor and trial management team the opportunity to collate findings from audit and monitoring reports to give complete oversight.  QuAD can be used to determine how well all research staff, research teams and departments involved in research are working in accordance with the standards at single or multiple sites for single or multiple studies.  By combining data from other sources it is also possible to relate findings from a series of reports to a single individual which might otherwise be overlooked from a single report.

QuAD provides a rapid and effective means of improving the standards of research at site, ultimately to ensure the health and wellbeing of participants and the integrity of the study data. QuAD in an essential tool for sponsor oversight

Enhancing Quality in Research at University Setting

R.M. Vilanova, S. Mata, J.O. Bernad, M. García, C. Navarro Quality Research Service, Agency for Quality Assurance, University of Barcelona

Key strategy Core facilities ISO 9001 certification

Support activities Control of Standard Operating Procedures (SOP)

GLP Archive

ICH Q10 for GMP customers Custody of certified standards

some GLP requirements in animal facilities for GLP customers.

Research groups

Knowledge transfer GLP ISO 9001 ISO17025 GMPs

Non regulated framework

Training

Staff in quality systems ( GLP, ISO 17025 and ISO 9001 )

In apparatus calibration of common use in laboratories (balances, pipettes, thermometers, incubators and UV-Vis spectrometers Teachers and technical staff as internal auditors of ISO 9001

Conclusion

The strategy developed by the Quality Research Service together with the additional support activities offered contributes to enhance quality in research at the University of Barcelona.

Implementing Quality Systems in University Core Facilities: a Strategy to Spread Quality Culture in Research R.M. Vilanova, C. Navarro Quality Research Service, Agency for Quality Assurance, University of Barcelona

Core Facilities: centralized scientific research infrastructures that allow research scientists shared access to sophisticated and expensive technologies.





Research groups: Obligation to release reliable and reproducible data to scientific community and society.

Lack of experience using Quality Management tools Track from samples to results

Equipment of high performance and the most current technology

Accessible to a wide range of scientists

Benefits

QA System

Core facilities values Well trained and expert staff

Data integrity Verification and calibration of equipment Validated methods Control of standards and reagents Training of students by expert staff

Core facilities are a good place to implement Quality Assurance best practices, spreading the quality culture to many researchers and contributing to the reliability of research data

Ensuring ICH GCP Compliance in Semi-Virtual Clinical Trials Using Direct to Patient (Off-Site) Research Nurses – Practical Considerations for Sponsors and CROs Background Number of trials involving “home care”, “direct to patient” or “Off-Site” component has been steadily increasing over the past 20 years. The use of off-site Research Nurses has further increased with the move towards virtual (or site-less) trials. Although technology has driven the change to this more decentralised trial model, the use of off-site Research Nurses is a key component of the more patient centric model.Following the ICH E6 (R2) update, European Medicines Agency (EMA) Inspectorate Working Group (WG) issued two new posts on the Q&A website in Dec 2018 to further clarify how compliance with ICH E6 (R2) can be achieved and what steps must be taken when including an external Off-Site Nursing provider (“Provider”) in any trial model.

Objectives The intention is to identify different categories of actions and responsibilities from the Sponsor/ Contract Research Organisation (CRO), Investigator Site (“Site”) and Provider, to comply with ICH GCP E6 (R2).

Sponsor/CRO Essential Documents Study design, patient condition and drug indication support and justify off-site services. Protocol and other key documents (e.g. Lab Manual) identify procedures to be carried out off-site. Informed Consent Documentation reflective of off-site process including data sharing (with provider and partners e.g. courier).

Approvals & Permissions

IRB/IEC and Competent Authority approval of Protocol and ICD containing Off-Site procedures.

Patient Safety

Sponsor/CRO and Site agreement (e.g. mCTA) refers to the Provider and how delegation of Investigator duties will be documented.

Data Integrity

Oversight

Review of source data worksheet template.

Ensuring Provider has procedures for quality control and quality assurance (vendor qualification).

Monitoring of data.

Regular communication with the -Site and Provider.

Patient Safety

Data Integrity

Oversight

Pre-visit handover between Site and Off-Site nurse to ensure all relevant safety information is completed.

Pre-agreed timelines for return of completed worksheets.

Regular contact between Off-Site Nurseand Site.

Data Integrity

Oversight

Quality control processes for data collected off-site.

Timelines for data provision to sites.

Secure storage of worksheets before return to Site.

Off-Site Nurse attending Site Initiation Visit and periodically visiting the site.

Regular communication between Site and Provider to schedule visits and exchange feedback.

Risk Management Plan to include risks associated with off-site procedures.

Financial agreement between Sponsor and Provider.

Site Essential Documents

Approvals & Permissions

Methods The available guidance was reviewed and interpreted by the members of the Illingworth Quality Assurance department, with further input and clarification from the Medicines and Healthcare products Regulatory Agency (MHRA), EMA and Health Research Authority (HRA) was obtained.

The results were categorised, and responsibilities assigned to each stakeholder (Sponsor/CRO, Site and Provider).

PI review of Provider Nurse’s CV and acceptance of proposed resource.

Contracts & Agreements Written agreement confirming delegation of Investigator duties, as well as assurance of pre-engagement checks (training and experience) between the Site and Provider.

Other Institution requirements (e.g. insurance or indemnification arrangements).

Conclusions Sponsors/CROs looking to implement virtual and semi-virtual trial models to achieve patient centricity should ensure early engagement of both the Site and the Provider.

This will allow for open communication and appropriate, documented division of responsibilities across all parties, in turn ensuring regulatory compliance.

Contracts & Agreements

Provider Essential Documents

Develop instructions for the Off-Site Nurses based on the protocol and relevant manuals.

Due diligence checks on the Protocol, ICD and other documentation to ensure OffSite procedures are adequately described.

Approvals & Permissions

Contracts & Agreements

Patient Safety

Strict process to ensure protection of Subject Identifiable Information.

Detailed country-specific due diligence to ensure compliance with data protection Financial agreement with regulations. the Sponsor, delegation Ensuring Life Support training agreement with the of Off-Site Nurses.

Strict pre-engagement Investigator (may be Study specific risk assessment checks for each per trial or a master for off-site visits. potential Off-Site agreement with individual Health and safety risk Nurse. scope of work). assessments for conducting offOR site visits.

Tri-partite agreement “Meet the Patient” visits at Site including all stakeholders. prior to the first off-Site visit.

StaySafe® platform for emergency notifications.

Procedure for direct reporting of SAEs and other AEs of interest to the Site.

Natalia Janik and Nikki Cooper, Quality Assurance Managers at Illingworth Research Group Ltd.

Passionate about research, compassionate about patients

Email: info@illingworthresearch.com

Website: www.illingworthresearch.com

Consideration of appropriate management of the GLP computerized system for data integrity - Analysis of data integrity issues from FDA warning letters Isao Watanabe: Shin Nippon Biomedical Laboratories, Ltd. Drug Safety Research Laboratories (SNBL DSR), Kagoshima, Japan Co-author: Japan Society of Quality Assurance (JSQA), GLP Division, Study Group 3, Subgroup 2, Team A

Introduction

Method

Globally, data integrity findings have been issued

Step 1

Result

Collected the FDA warning letters of data integrity issues related to computerized systems Search on FDA website Warning letters from April 2016 to August 2019 33 warning letters from 9 countries in cGMP

Data integrity issues according to data lifecycle phase Archive/ Retrieval Review/ Reporting/Use

Regulatory inspection

What should be the focus point to improve data integrity at the GLP facility in Japan ?

Is staff training sufficient ?

Are effective controls in place for legacy systems ?

In facilities where sufficient training on data integrity is not provided to staff, there is a concern that a lack of understanding will cause data integrity issues.

Also, many facilities use legacy systems (insufficient functionality) and effective controls are required to ensure data integrity in such systems. Therefore, we adopted the methods described herein to consider appropriate management of the GLP computerized system focused on data integrity in Japan.

Purpose

Warning Data Integrity Issue Letter No.

320-16XX

The trial injection data files were stored on separate drives from the reported test result data.

320-16XX

Multiple integrations were conducted without justification.

・・・

・・・

Data lifecycle phases* Generation Processing Review/ Archive/ Destruction Reporting/Use Retrieval

Focus point

*One issue may be classified into multiple phases

Phase

Main finding

Generation

Inadequate control of computer clock or audit trail Sharing a username and password Storing on separate storage from the reported data Multiple integrations or data deletion without justification System administrator rights are assigned to staff with a direct interest in the data Only the passing result was reported in the official record.

Review/Reporting/Use

(There were no applicable issues in this phase. ) Destruction

Processing

Discussion and Conclusion

Certificates of Analysis can be manipulated or deleted Unable to retrieve the data Archive/Retrieval

Data lifecycle

Generation

62 issues were categorized into the 5 phases

Processing

To identify the focus point to improve data integrity based on categorizing according to the data lifecycle.

FDA warning letters

Step 2 Categorized the data integrity issues of the FDA warning letters to the 5 phases of the data lifecycle

The extracted findings from the FDA warning letters were categorized into the 5 phases of data lifecycle.

About 85% of data integrity issues extracted from FDA warning letters were categorized in the early phases of data lifecycle (generation and processing). Data integrity issues are likely to occur in the early phases of data lifecycle and may be the inspector's focus point.

As a result, it is considered that the priority for GLP facilities to improve its response to data integrity should be focusing on the generation and processing phases of the data lifecycle. We plan to conduct activities to propose to Japan GLP facilities, measures for data integrity focusing on the generation and processing phases of the data lifecycle and to establish procedures for that purpose.

Focus point of the data lifecycle to improve data integrity at the GLP facility from this approach Generation Processing

Challenges of abuse liability studies conducted in compliance with GLP Barbara Vaccarini1, Michela Tessari2, Massimo Breda3 and Gabriele Pesavento1 Aptuit (Verona) Srl, an Evotec Company, Via Alessandro Fleming, 4-37135 Verona Italy, 1Quality Assurance, QU; 2Abuse Liability/Safety Assessment, PCD; 3Preclinical Sciences & GLP/GCP Compliance

1. Introduction

2. Regulatory Requirements

The preclinical abuse liability assessment is a critical component in the development of new molecular entities (NMEs) with targeted or indirect effects on the central nervous system (CNS) supporting the safety evaluation as required by the Regulatory Agencies (FDA, 2017; ICH M3 [R2], 2009; EMA, 2006).

Recent FDA guidance recommends that preclinical abuse liability evaluation must be conducted in compliance with GLP.

Drug abuse is defined as the intentional, non-therapeutic use of a drug product or substance to achieve a desired psychological or physiological effect.

Specific preclinical abuse-related studies are usually conducted in rats once the therapeutic dose range is determined after completion of Phase 2 clinical trials in order to evaluate:  whether a drug has rewarding or reinforcing properties (self-administration study and conditioned place preference study)  whether a drug has subjective and interoceptive effects that are similar to known drugs of abuse (drug discrimination study)  the ability of a drug to produce physical dependence after chronic administration (spontaneous withdrawal symptoms)

http://www.med-associates.com/medlines/Summer2012/InYourLab-Summer2012.html

However, the requirement for GLP compliance in this specific field is difficult due to:  the nature of the studies, where experimental designs are complex and phase progression is based on individual animals’ behaviour, thus not predictable in advance  the validation of computerised systems that have been developed to be used in a research environment  a complex data flow from the acquisition to the statistical elaboration and final reporting

From Solinas et al., Nature, 2006

Figure 1: Schematic representation of an operant chamber used for a self-administration experiment (upper figure) or drug discrimination experiment (lower figure).

3. GLP implementation approach

QUALITY ASSURANCE PROGRAMME Figure 2: Data flow from acquisition to archiving

Figure 3: GAMP 5: a Risk-Based Approach to Compliant Computerized Systems.

Risk assessment to identify the critical steps and put in place the controls and check points to mitigate the risk on data integrity in these steps: 1. Data acquisition 2. At the end of acquisition data are saved on the lab computer as a text file that is automatically transferred in a secure network area 3. Data are loaded into a non-editable MS Access database through MED2Access tool; validated queries are then executed to assess the data 4. If further data analyses are required, the data are imported in SAS for statistical elaboration and 100% quality checked 5. Data are moved from the secure area to an electronic archive

Following the GAMP guideline a risk based approach has been used to commensurate the validation effort of the systems used for data acquisition, transfer, elaboration and archive:  MED-PC for operant chamber control and data acquisition  MED to Access tool is a bespoke tool for data transfer  SAS for data elaboration  NuGenesis for electronic data archiving

Corporate Headquarters: Evotec SE, Manfred Eigen Campus, Essener Bogen 7, 22419 Hamburg, Germany

Email: info@evotec.com

Web: www.evotec.com

The Quality Assurance Programme is based on a documented risk based approach.

The following inspections are performed:  Protocol/Amendment  Study-based inspections on critical phases identified with support of Study Directors/Scientist  Process-based inspections are conducted to monitor procedures or processes of a routine and repetitive nature  Facility inspection that covers the laboratory  Report and data review  Periodic compliance review of computerized systems

Improvement of Quality Assurance Systems for Advanced Therapies Medicinal Products development Castagnaro Laura1,3, Zancan Stefano1,2, Albertini Paola1,2, Corti Consuelo3, Parezanovic Vanda4, Cicalese MariaPia1,3, Zino Elisabetta1,4, Costantini Rossella1, Ciceri Fabio1,3, Naldini Luigi1, Aiuti Alessandro1,3 1 2 3 4

- San Raffaele Telethon Institute for Gene Therapy (SR-TIGET), IRCCS San Raffaele Scientific Institute, Milan, Italy - Telethon Foundation, Milan, Italy - Stem Cell Program, IRCCS San Raffaele Scientific Institute, Milan, Italy - Organization & Quality Management Office in Research, IRCCS San Raffaele Scientific Institute , Milan, Italy

Directed by Prof. Luigi Naldini, the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET ) is a joint venture between Fondazione Telethon and IRCCS Ospedale San Raffaele (OSR), San Raffaele Scientific Institute. It was established in 1995 in order to create new standards of care for Rare Diseases, translating our basic research discoveries into gene therapy treatments for patients. For each developmental step different standard and requirements have to be followed, so different Quality Assurance systems have been created in order to regulate basic research/pre-clinical/ clinical and clinical trial steps. QA systems are strictly connected to each other in order to achieve the common final goal ensuring regulation compliance and data integrity. This poster describes how these Quality Systems have been improved during time, how they are interrelated and how they play a key role in the new strategies development.

SR-TIGET ATMP DEVELOPMENT MODEL Basic Research

Pre-Clinical Research

Clinical Research

IDEA! Pre-Clinical Proof of concept

in vivo and in vitro model

Phase I to III Clinical Proof of concept

Registration phase

GENE THERAPIES DEVELOPED in SR-TIGET Starting as basic research, in the last 20 years many gene therapies trials have been developed in the academic contest of SR-TIGET.

Clinical Study Reports, MAA

Market Access

Achieved also with Pharma Industry Alliances

SR-TIGET QUALITY IMPROVEMENT MILESTONES of SR-TIGET Clinical research unit Trial Office (TCTO) and 2010 Creation Paediatric immunehaematology/Clinical Research Unit (UOPI)

Begin of GSK Partnership

First Patient treated ADA SCID TRIAL

WAS&MLD TRIAL

BTHAL TRIAL

2000

2010

2015

Creation of GLP SR-TIGET Test Facility (GLP TF) Lab for pre-clinical studies according to GLP standard, certified by Italian Ministry of health

2016

Creation of SR-TIGET Clinical Lab (TCL) Lab for the execution of analytical test for clinical trials according to GCP/GCLP standards

OSR Stem Cell program (SCP) Units: Adult Haematology Transplant, Bone Marrow Harvest, Therapeutic Apheresis, Cell Manipulation Lab Clinical Procedures for ATMP

Paediatric Immunehaematology Unit (UOPI)/TCTO Clinical trial: Development of new clinical trial, clinical operation, patient management

SR-TIGET Clinical Lab (TCL) Clinical trial: Biological sample manipulation, analytical test

2018

2019

ISO 9001:2015 certification both for UOPI (2008) and TCTO (2011) UOPI is part of OSR Stem Cell Program JACIE accreditated since 2014 Both UOPI and TCL are authorized to conduct Phase I Clinical Trials (2018), as per minimum requirements requested by Italian Medicines Agency (Determina AIFA n 809/15).

QUALITY SYSTEMS INTERACTIONS

ACTIVITIES INTERACTIONS

Preclinical studies: biodistribution, Tox tumorgenicity, analytical methods validation Clinical trial: analytical methods validation

2016

MPS1 TRIAL

Other quality standards and certifications, related not only to Clinical Trial, are instrumental to ensuring high quality processes, data integrity, privacy and patient safety.

Moreover, GMP and GDP external facilities (manufacturer, courriers) are involved but general knowledge of their principal processes and quality systems is an essential condition to mantain a correct overview in a clinical trial.

GLP SR-TIGET Test Facility (GLP TF)

STRIMVELIS

…GxP ALONE?

Physicians and Office staff dedicated to development of clinical trials according to GCP

2014

ADA SCID Market Asses (AIFA, EMA, NICE)

Partnership from GSK to OTL First 100 pt treated

OSR (ISO 9001 based Quality System) SCP

• • • •

CAPA, Trial SOPs, Internal Audit Trial Indicators

UOPI • SOPs general and Unit specific • Internal Audit JACIE • Clinical Indicators

TCTO

• GCLP methods SOPs • CAPA

TCL

• General SOPs • Internal Audit GCP/ISO

• Internal Audit • Methods Validation

• GLP methods SOPs • CAPA

GLP TF

A Quality Manager for each system is appointed, responsible for the set up and maintenace of standards requirements and adequate communication between different systems.

Surveys in nutritional research, what matters for QA compliance?

Helene Clavien, Quality Manager Clinical Development Unit Nestlé Research, Lausanne Switzerland Nutritional surveys are not clinical trials but imply collection of health-related personal data.

Compliance with ethical and scientific principles is essential, though adherence to full ICH GCP may not be applicable.

• What might go wrong in survey research type?

• What are the likelihood and consequences if something goes wrong?

• How to control and mitigate the risks?

Quality Management – QA and QC Medical Expertise - CRO / Vendor

Appropriate informed consent process Data handling compliant as per local data protection and privacy laws

Data integrity

Trial Design - Trial Management Investigator selection - Allocation of responsibilities Compensation to subjects and investigators - Financing Notification/Submission/Review to regulatory authorities - IRB/IEC

Investigational Products Management Safety Adverse reaction reporting

Record access - Monitoring – Audit – Non compliance Trial closure

-

Clinical trial study report

Health, nutrition, and lifestyle surveys are agile research tools for understanding trends and emerging concerns in nutrition and health. Used effectively, risk-based approach is the best tool to support compliance decisions and ensure data integrity. .

3rd European QA Conference in Dublin, November 2019

Introduction

Conventional

Reporting results in a regulatory laboratory, has evolved rapidly through electronic systems becoming more complex and gaining in functionality. While technology has moved on at a rapid rate, has our approach to auditing the generated data kept pace?

Have the following questions been asked: Where is the risk?

Where should the effort of audit be focused?

Background 1

MHRA trend analysis of GLP findings from 2014/15 - 2017/18 show a 6.5 fold increase in major deficiencies categorised as Study Conduct. This can be partially explained by the increased use of e-systems, of increasing increasing complexity and the publication of the MHRA Data Integrity Guidance.2 A key function of QA is to provide assurance to stakeholders by performing compliance assessments (audits). The conventional approach to these assessments is reactive; a greater benefit to the organisation is for them to be proactive.

The Challenge The conventional audit checks the final values against the raw data and verifies the work can be reconstructed. The audits performed are either observational (observing the phase being performed) or retrospective (recreating the work using records/raw data, SOPs, work instructions and plans) Key areas frequently overlooked; the steps to generate the final reported data the e-system controlling the process or phases of the process interviewing personnel re-occurring issues

Observational Audit; None

Observational Audit; Sample Receipt Sample Storage Preparation of standards,samples

Retrospective Audit; Regulatory requirements met?

Retrospective Audit; Review records for: sample receipt standards samples

Observational Audit; Retrospective Audit; Instrument Setup Instrument setup Loading of samples Sample Sequence

Observational Audit; Retrospective Audit; None Sample review of reported numbers

Observational Audit; Retrospective Audit; Evidence of QC None

Innovative

Plan / Request

Preparation

Analysis

Reporting

Review

Observational Audit or Retrospective Audit; Assignment of Responsible Person Generation of plan / request Set-up of electronic system (e-system) Quality Control

Observational Audit; Sample Receipt, how automated i.e barcodes Sample Storage Preparation of standards, samples Retrospective Audit; e-system interrogated for anomalies audit trails changes to set-up

Observational Audit; How the values are transferred to the report

Planning the audit programme When planning an audit programme the entire process from cradle to grave should be considered.

Process map the entire sequence of events from observing the process and identify the steps which are; managed by an e-system interaction between e-systems e.g instrument software to LIMS managed by human intervention If the process or steps are managed by the e-system it is not necessary to audit for every study. The functionality of the e-system must be understood. Is there functionality to interrogate the records to identify potential issues? Such as audit trails or running queries. The audit must provide confidence of the functionality and continual validation status of the e-system. Records must be available for any changes to the system by the use of change control.

If the process or steps are managed manually the impact of an error in that step must be assessed for risk. It is not necessary to audit for every study if there is historical evidence the process or steps are robust.

Observational Audit; How the QC is performed What is checked; audit trails, manual entry Is the QC suitable for the e-systems in use?

Process map

Observational Audit; None

Retrospective Audit; None

Case Study QA identified values which had been omitted from the table of sample concentration data provided for audit. Values missing were from an entire ‘analytical run’. The findings were reported to the responsible scientist. QA reported that this was a common occurrence and yet had not been investigated.

Routine audits did not identify any issues with the analytical phase.

A non-routine audit comprising of the data transfer from the e-system to the final reported data format, a CSV file, was conducted.

The Documented Process (SOP) A CSV file is set-up for each study The CSV file was designed for multiple data transfers from the e-system On each data transfer the CSV file is saved as a new document therefore no overwriting of files The file name format was studynumber_date The run data and CSV file is subject to QC check as each is completed. The request for QC is against a specific file name The Observed Process Analyst opened the latest CSV file as identified by the date in the file name with the notification 'File in Use the file is locked for editing' this message was ignored and the data was transferred The CSV file was saved with the prefix ‘copy’ This generated a 'copy' of the CSV file - the analyst was unaware of what this meant The CSV file was QC'd as each run completed therefore no errors found Investigation When the file is opened by another user the error message appears. A copy is created which does not include the data added by the other user The folder containing the CSV files included duplicate files with the prefix ‘copy’ Analysts were not transferring data to the latest version of the CSV file.

Release

Observational or Retrospective Audit; Final approval of data Transfer to stakeholder

Electronic versus human intervention

Functionality validation status

Risk assessment

Advancing the audit programme Learnings from the case study Process mapping of the steps from e-system to tables detailed the documented procedure and did not reflect the actual process followed The testing of the transfer from the e-system to the CSV file had not included concurrent users System error messages were not questioned or investigated and there was no documented process for the handling of errors Version controls of the CSV file were not appropriate Routine audits did not cover the entire processes of the study There was no verification that the QC process was appropriate There was no check of the complete final data set QA findings were reported in isolation without a method of identifying recurring issues

e-Systems The ideal purpose of an e-system is to generate records which minimises the level of manual recording.

To design an audit program two elements must be considered; Human intervention Validated functionality The audits must be tailored according to the e-system, frequency of use, impact on the data and regulatory requirements.

The audit programme must be reviewed but when? e-system changes new e-systems has risk been lowered areas identified as an increased risk changes in the regulatory requirements changes in the facility Revisit the process map, verify if the sequence of events have evolved, this can be conducted during the audit program or as a separate exercise.

Final thoughts The conventional approach to audits and audit programmes may not always suitable with e-systems. In order for audits to be aligned to current technology there must be an understanding of the entire process; both e-system and human intervention points within. QA should fully understand the e-system; how data is generated, managed and how to interrogate to reconstruct the analysis to be able to design an integrated audit program within the quality system.

References 1. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/7 69279/GLP_Deficiency_metrics_2017_2018.pdf 2. MHRA 'GXP' Data Integrity Guidance and Definitions, March 2018

Contact us for more info Authors www.tmqa.co.uk Cate Ovington, Principal Associate or visit TMQA on stand #21 Rita Silvestre, Associate