Data Integrity Validation Keynote Address Boston August 2016Ajaz Hussain
Critical Update — Navigate the 2016 FDA Data Integrity Compliance Draft Guidance and Other Global Regulations
Evaluate the Global Regulatory Landscape
Expectations of the 2016 FDA Draft Guidance
Overcome Top Challenges
Proactive Approach to Assurance of Data Integrity
Bonus Material
Identifying Drug Interaction Candidates in Real-World DataNeo4j
Speakers: Kathleen Mandziuk, Vice President, Patient Strategy and Digital Health, PRA HealthSciences
Nathan Smith, Senior Principal Data Scientist, PRA HealthSciences
Kerry Deem, Associate Director, Programming, PRA HealthSciences
These are the slides for a presentation I gave at the Health Informatics Scotland on October 7, 2015 - summarizing joint work with Konstantin Knorr, David Aspinall, and Kami Vaniea on security and privacy in health apps (or lack thereof).
Risks of Open Payments and Medicare Part D Dataqordata
This SlideShare is aimed at providing a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. Compiled by Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, it will also present information about the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.
Data Integrity Validation Keynote Address Boston August 2016Ajaz Hussain
Critical Update — Navigate the 2016 FDA Data Integrity Compliance Draft Guidance and Other Global Regulations
Evaluate the Global Regulatory Landscape
Expectations of the 2016 FDA Draft Guidance
Overcome Top Challenges
Proactive Approach to Assurance of Data Integrity
Bonus Material
Identifying Drug Interaction Candidates in Real-World DataNeo4j
Speakers: Kathleen Mandziuk, Vice President, Patient Strategy and Digital Health, PRA HealthSciences
Nathan Smith, Senior Principal Data Scientist, PRA HealthSciences
Kerry Deem, Associate Director, Programming, PRA HealthSciences
These are the slides for a presentation I gave at the Health Informatics Scotland on October 7, 2015 - summarizing joint work with Konstantin Knorr, David Aspinall, and Kami Vaniea on security and privacy in health apps (or lack thereof).
Risks of Open Payments and Medicare Part D Dataqordata
This SlideShare is aimed at providing a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. Compiled by Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, it will also present information about the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.
The Danger of Big Data by Kerry Bodine - Forrester research
Service design teams can glean big data insights from social media, financial systems, emails, surveys, call centers, and digital and analog sensors. But companies that fixate on amassing new data sources put themselves at risk of neglecting small data insights gathered through qualitative research methods. How can firms achieve balance?
The Exhaustive Study for “23andMe Market” Research Report is added on Orbisresearch.com database. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.
Managing The Risk of Open Payments - Validate Spend Report Before CMS Submissionqordata
This presentation is meant to help you understand how you, as a pharmaceutical company, can protect yourself from risks of audit and fines even before you submit your final report to CMS.
As many blockbuster drugs reach their patent cliffs, pharmaceutical companies and their service providers are searching to make drug development a more efficient process. Here are just a few of the trends to look for in the coming years.
Learn more: http://bit.ly/1LSIgwJ
2012 DIA eSource monitor-site-sponsor relationshipEd Seguine
This presentation discusses some of the unique impacts on the clinical trial process for Monitors, Sites, and Sponsors as they adopt electronic source records.
Galen healthcare solutions Healthcare Information Technology 2017 Year in Rev...Justin Campbell
In the ever-changing and fast-paced world of healthcare IT, there can be a lot to keep up with. As 2017 wraps up and we look towards 2018, we take the opportunity to review the major happenings in the industry this past year, and explore key focal areas for the next. We’ve compiled insights gleaned from our market research conducted through attending industry conferences, gathering healthcare executive perspectives, and observing what is occurring in practice, to distill the key areas of focus for 2018. We’ll examine topics critical to the success of Healthcare Delivery Organizations (HDOs) including:
Application Portfolio Rationalization – Data Migration & Archival
Patient Engagement through Telehealth & Telemedicine
Clinician Engagement, Satisfaction, and Data-Driven Clinical Optimization
Clinical Decision Support – Syndromic Surveillance, Sepsis Prevention
Quality Payment Programs – Medicare Advantage, HCC & PCMH
Interoperability – HIE, APIs, Patient Identity & Matching
This webinar will provide a blueprint to assist healthcare information technology stakeholders in understanding key issues affecting the healthcare industry. Attendees will gain insightful resources and analysis of the healthcare information technology landscape in 2018. Register now to learn how these key trends could affect your organization and what you can do to prepare.
Why should a health plan invest in integrated solutions when providers have more to gain? How to remove the risks of moving forward without an industry standard? Safe harbor investment? Is an all-payer/all-provider solution even possible today? How do I justify an investment in workflow automation and backend system integration? This is a webinar on extension of the successful conversation on claims attachments raised at WEDI National 2016. Three healthcare vendors came together to discuss how to overcome key challenges by leveraging current investments in a multi-vendor model.
US value & outcomes-based, innovative bio / pharmaceutical contracts are set to be big news in 2018. Learn the latest trends and understand which payers, manufacturers & therapy areas are leading the way.
Next Generation Compliance: Using Analytics to Reduce Compliance Riskqordata
In this SlideShare, we will cover a compliance officer’s perspective on using analytics to enhance existing compliance and monitoring programs.You will also get a hands-on walk-through of top three methods that compliance officers can use to effectively monitor spend programs and reduce spend submission risks throughout the year.
Canadian AI 2014 Conference Keynote - Deploying SMC in PracticeKhaled El Emam
There is significant pressure to link and share health data for research, public health, and commercial purposes. However, such data sharing must be done responsibly and in a manner that is respectful of patient privacy. Secure multi-party computation (SCM) methods present one way to facilitate many of these analytic purposes. In fact, in some instances SCM is the only known realistic way allow some of these data disclosures and analyses to happen (without having to change the law to selectively remove privacy protections). This talk will describe two recent real-world projects where SMC was applied to address such data sharing concerns. The first was to measure the prevalence of antimicrobial resistant organism (e.g., MRSA) infections across all long term care homes in Ontario. A SMC system was deployed to collect data from close to 600 long term care homes in the province and establish a colonization and infection rate baseline. The second project pertains to securely linking large databases to allow de-duplication and secure look-up operations without revealing the identity of patients. This system performs approximate matching while maintaining a constant growth in complexity. In both of these cases a number of theoretical and engineering challenges had to be overcome to scale SCM protocols to operate efficiently and to transition them from the laboratory into practice.
Considerations for companies debating implementing blockchain based databases...Darshan Kulkarni
Enabling patient engagement using block chain based databases. This presentation looks at current silos, potential future silos and discusses solutions that have been offered
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
The Danger of Big Data by Kerry Bodine - Forrester research
Service design teams can glean big data insights from social media, financial systems, emails, surveys, call centers, and digital and analog sensors. But companies that fixate on amassing new data sources put themselves at risk of neglecting small data insights gathered through qualitative research methods. How can firms achieve balance?
The Exhaustive Study for “23andMe Market” Research Report is added on Orbisresearch.com database. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.
Managing The Risk of Open Payments - Validate Spend Report Before CMS Submissionqordata
This presentation is meant to help you understand how you, as a pharmaceutical company, can protect yourself from risks of audit and fines even before you submit your final report to CMS.
As many blockbuster drugs reach their patent cliffs, pharmaceutical companies and their service providers are searching to make drug development a more efficient process. Here are just a few of the trends to look for in the coming years.
Learn more: http://bit.ly/1LSIgwJ
2012 DIA eSource monitor-site-sponsor relationshipEd Seguine
This presentation discusses some of the unique impacts on the clinical trial process for Monitors, Sites, and Sponsors as they adopt electronic source records.
Galen healthcare solutions Healthcare Information Technology 2017 Year in Rev...Justin Campbell
In the ever-changing and fast-paced world of healthcare IT, there can be a lot to keep up with. As 2017 wraps up and we look towards 2018, we take the opportunity to review the major happenings in the industry this past year, and explore key focal areas for the next. We’ve compiled insights gleaned from our market research conducted through attending industry conferences, gathering healthcare executive perspectives, and observing what is occurring in practice, to distill the key areas of focus for 2018. We’ll examine topics critical to the success of Healthcare Delivery Organizations (HDOs) including:
Application Portfolio Rationalization – Data Migration & Archival
Patient Engagement through Telehealth & Telemedicine
Clinician Engagement, Satisfaction, and Data-Driven Clinical Optimization
Clinical Decision Support – Syndromic Surveillance, Sepsis Prevention
Quality Payment Programs – Medicare Advantage, HCC & PCMH
Interoperability – HIE, APIs, Patient Identity & Matching
This webinar will provide a blueprint to assist healthcare information technology stakeholders in understanding key issues affecting the healthcare industry. Attendees will gain insightful resources and analysis of the healthcare information technology landscape in 2018. Register now to learn how these key trends could affect your organization and what you can do to prepare.
Why should a health plan invest in integrated solutions when providers have more to gain? How to remove the risks of moving forward without an industry standard? Safe harbor investment? Is an all-payer/all-provider solution even possible today? How do I justify an investment in workflow automation and backend system integration? This is a webinar on extension of the successful conversation on claims attachments raised at WEDI National 2016. Three healthcare vendors came together to discuss how to overcome key challenges by leveraging current investments in a multi-vendor model.
US value & outcomes-based, innovative bio / pharmaceutical contracts are set to be big news in 2018. Learn the latest trends and understand which payers, manufacturers & therapy areas are leading the way.
Next Generation Compliance: Using Analytics to Reduce Compliance Riskqordata
In this SlideShare, we will cover a compliance officer’s perspective on using analytics to enhance existing compliance and monitoring programs.You will also get a hands-on walk-through of top three methods that compliance officers can use to effectively monitor spend programs and reduce spend submission risks throughout the year.
Canadian AI 2014 Conference Keynote - Deploying SMC in PracticeKhaled El Emam
There is significant pressure to link and share health data for research, public health, and commercial purposes. However, such data sharing must be done responsibly and in a manner that is respectful of patient privacy. Secure multi-party computation (SCM) methods present one way to facilitate many of these analytic purposes. In fact, in some instances SCM is the only known realistic way allow some of these data disclosures and analyses to happen (without having to change the law to selectively remove privacy protections). This talk will describe two recent real-world projects where SMC was applied to address such data sharing concerns. The first was to measure the prevalence of antimicrobial resistant organism (e.g., MRSA) infections across all long term care homes in Ontario. A SMC system was deployed to collect data from close to 600 long term care homes in the province and establish a colonization and infection rate baseline. The second project pertains to securely linking large databases to allow de-duplication and secure look-up operations without revealing the identity of patients. This system performs approximate matching while maintaining a constant growth in complexity. In both of these cases a number of theoretical and engineering challenges had to be overcome to scale SCM protocols to operate efficiently and to transition them from the laboratory into practice.
Considerations for companies debating implementing blockchain based databases...Darshan Kulkarni
Enabling patient engagement using block chain based databases. This presentation looks at current silos, potential future silos and discusses solutions that have been offered
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
Webinar slides on Data Integrity 101
Organized by: One Quality Solutions Ltd.
Date: 19 May 2023
Time: 09:00-10:00 pm (BST)
Data Integrity in Pharmaceutical Industry is a hot topic now. Due to emerging technology, maintaining integrity of data is a very big challenge. If the challenges are not managed appropriately, there is high potential to receive regulatory enforcement actions including FDA 483s, warning letter or shut down of the pharmaceutical plant. So, it is very important to understand the basic requirements of Data Integrity.
Topics:
1. Introduction to Data Integrity
What is Data Integrity?
Why it is important?
Key Definitions
2. ALCOA+ Principles
History of ALCOA+
ALCOA+ and ALCOA++
3. Document Control
Example observation from Warning Letter
How to implement document control?
4. User Access Management
Example observation from Warning Letter
How to implement user access management?
5. Audit Trail Review
Example observation from Warning Letter
How to implement audit trail review?
Speakers:
Mohammed Raihan Chowdhury
Head of Quality Systems and Services
One Quality Solutions Ltd.
Ex-Data Integrity Lead of Novartis Bangladesh
and
Sharmin Afroz
Sr. Asst. Manager, Product Development-ARD
Data Integrity Expert of Laboratory Instrument
Radiant Pharmaceuticals Ltd.
Bangladesh
Host:
Najmun Nahar
Marketing Executive
One Quality Solutions Ltd.
Pinch-Hitting in Heidelberg 16 October 2013Ajaz Hussain
Last minute request to fill gaps in the program due to US Gov shutdown. Key topics: Process Validation, Continuous Manufacturing, Statistical Confidence, Quality by Design.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Tr...Target Health, Inc.
DIA 2019 presentation by Dr. Jules Mitchel with Michelle Eli (Lilly) and Tom Haag (ex-Novartis) based on their experience with Lilly collaborating on Target Health's paperless clinical trial system.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
Incorporating Commercial and Private Data into an Open Linked Data Platform f...Alasdair Gray
The Open PHACTS Discovery Platform aims to provide an integrated information space to advance pharmacological research in the area of drug discovery. Effective drug discovery requires comprehensive data coverage, i.e. integrating all available sources of pharmacology data. While many relevant data sources are available on the linked open data cloud, their content needs to be combined with that of commercial datasets and the licensing of these commercial datasets respected when providing access to the data. Additionally, pharmaceutical companies have built up their own extensive private data collections that they require to be included in their pharmacological dataspace. In this paper we discuss the challenges of incorporating private and commercial data into a linked dataspace: focusing on the modelling of these datasets and their interlinking. We also present the graph-based access control mechanism that ensures commercial and private datasets are only available to authorized users.
http://link.springer.com/chapter/10.1007/978-3-642-41338-4_5
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
As per the USFDA guidelines there are about 38 drugs has banned in India due to poor handling of DATA INTEGRITY SYSTEMS. We at Marcep Inc. proud to announce the need of an hour by organizing the above mentioned training program.
Register early as all the locations are fast filling to avoid disappointment.
Presentation: Data Integrity – an international regulatory perspectiveTGA Australia
This presentation will provide an overview of the international regulatory perspective on data integrity and discuss some of the key points highlighted in recently released guidance documents from across the globe.
Data integrity - Regulatory Perspective and Challenges: santoshnarla
Data Integrity: Regulatory Perspective and Challenges.
This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges.
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1. Page 1
DATA INTEGRITY
Monday, April 27, 2015
"This presentation is compiled from resources available on the world wide web.
“Drug Regulations” is a non profit organization which provides free online resource
to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.”
2. Page 2
DATA INTEGRITY
Data Integrity is assuming greater
importance in cGMP’s.
Quality of raw materials, in process
materials and finished goods can not be
assured with out data integrity.
Data integrity issues are 21 CFR Part 11 and
severe CGMP violations.
3. Page 3
DATA INTEGRITY
If the integrity of laboratory data is
compromised.
o Products may not comply with regulatory
authorization terms.
o Products can not be released for sale.
In recent past FDA has Increased its focus on
data integrity and reliability.
Similarly MHRA and Other regulatory bodies
have increased focus on data integrity.
4. Page 4
DATA INTEGRITY
Inspectors are examining data based on
multiple regulations and standards.
o CGMP
o Good Laboratory Practices (GLP),
o Good Clinical Practices (GCP) and
o The Application Integrity Policy.
5. Page 5
DATA INTEGRITY
“Guilty until proven innocent” approach.
Historical approaches based on technical
justification and scientific rationale not
adequate.
Emphasis on providing evidence that the
analytical results are not fraudulent.
6. Page 6
What is DATA INTEGRITY?
Data integrity is the assurance that data
records are accurate, complete, intact and
maintained within their original context,
including their relationship to other data
records.
This definition applies to data recorded in
electronic and paper formats or a hybrid of
both.
7. Page 7
Ensuring DATA INTEGRITY:
Protecting original data from
Accidental modification
Intentional Modification
Falsification
Deletion
8. Page 8
DATA INTEGRITY:
Data Integrity key to
Reliable and trust worthy records
Record that will withstand scrutiny during
regulatory inspections.
According to FDA, which uses the acronym
ALCOA, data need to be “attributable,
legible, contemporaneous, original, and
accurate.”
10. Page 10
Revealing list of DATA INTEGRITY observation in
FDA Audits:
“…..trial injections…..”
“results failing specifications are retested
until acceptable results are obtained….”
“…..over-writing electronic raw data…..”
“…….OOS not investigates per XYZ SOP….”
“……appropriate controls not established…..”
“……records are not completed
contemporaneously…”
“….observed back-date entry in logbooks.”
14. Page 14
DATA INTEGRITY:
Data integrity is the assurance that data a consistent
,accurate , reliable and accessible
Data
Assuring
Accuracy
Completeness
Consistency
Reliable
Accidental-Un intentional
Unauthorized-Malicious
Generating
Transforming
Maintaining
Entire life cycle
NOT
Altered
Destroyed
Modified
22. Page 22
Data Integrity Regulations:
FDA inspects for electronic data integrity
during the pre- and post market product
approval process.
21 CFR Part 11 commonly referred to as
the “data integrity regulation.” Four goals
listed by FDA.
Assess the industry’s comprehension or
continuing misinterpretations of Part
11.
Determine how firms are ensuring the
integrity of electronic records.
Extend scrutiny of data, quality-related
and computerized system validation-
related Form 483 inspectional
observations since 2007.
23. Page 23
Electronic & Paper Data:
Comparisons between secure electronic data
and data in paper format
For software compliant to 21 CFR Part
11 (9) & with appropriate technical
controls.
Electronic data are more secure, more
difficult to manipulate or change, and
any changes are easier to detect.
Changes to paper data, such as a
printed chromatogram, are simpler to
make, but much harder to detect.
24. Page 24
Electronic & Paper Data:
Comparisons between secure electronic data
and data in paper format.
Defining paper records as “raw data”
(the so-called typewriter rule) does not
satisfy the predicate rules.
Printed paper copy of the
chromatogram will not be considered a
true copy.
Although this comment was made
about chromatographic data, the
principles have much wider
implications.
