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.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
www.3-14.com
Source Data expectations for the life sciences industry. Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
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; 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.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
www.3-14.com
Source Data expectations for the life sciences industry. Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
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; 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.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
An exploration of the topic of Data Integrity including consequences of international regulatory collaboration on the subject, highlights of recent overseas and international guidance documents, as well as common misconceptions.
Quick Overview: Pharmaceutical Data IntegrityPeter Dellva
Brief overview of the most important aspects of pharmaceutical data integrity. Slideshare includes pharmaceutical and biopharmaceutical industry key resources.
As per EU MDR, Post Marketing Clinical Follow-up (PMCF) is a continuous process where device manufacturers need to proactively collect and evaluate clinical data of the device when it is used as per the intended purpose. EU MDR gives more emphasize on PMCF data to confirm the safety and performance of the device throughout its expected lifetime, ensure continued acceptability of identified risks and detect emerging risks based on factual evidence.
Learn how Q-Pulse, a quality management solution, can help organisations within the life science industry to maintain data integrity. This is particularly critical for pharmaceutical companies.
Machine Learning for Predictive Data Analysis in Clinical ResearchClinosolIndia
Machine learning (ML) techniques have the potential to revolutionize predictive data analysis in clinical research by enabling researchers to uncover insights, make informed decisions, and develop more personalized treatment approaches. Here's how machine learning can be applied to predictive data analysis in clinical research
Data Cleaning and Validation: Best Practices for Data IntegrityClinosolIndia
Data cleaning and validation are critical processes to ensure the integrity, accuracy, and reliability of clinical data. These best practices can help maintain data quality and enhance the validity of research outcomes:
Define Data Cleaning and Validation Procedures Early: Establish clear data cleaning and validation procedures as part of the study protocol or data management plan. Define data validation rules, data range checks, and data cleaning criteria upfront to ensure consistency and adherence to predefined standards.
Use Electronic Data Capture (EDC) Systems: Implement EDC systems that offer built-in data validation checks, range validations, and skip patterns. EDC systems can prevent certain types of errors during data entry and facilitate real-time validation as data is collected.
Develop Data Validation Checks: Create automated validation checks to identify discrepancies, outliers, missing data, and inconsistencies. These checks can include cross-field validations, data range validations, and logical validations based on predefined rules.
Standardize Data Entry: Enforce standardized data entry formats and units to minimize variability and errors. Provide clear instructions to data entry personnel to ensure consistent and accurate data collection.
Implement Double Data Entry and Review: For critical data points, consider implementing a double data entry process where data is entered by two independent personnel. Any discrepancies between the two entries are flagged for resolution. A third reviewer can adjudicate discrepancies if necessary.
4DAlert data house platform is a sophisticated and user-friendly solution that enables efficient data management for any organization. Visit: https://medium.com/@nihar.rout_analytics/what-is-data-observability-ece66dcf0081
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.
Healthcare Data Quality & Monitoring PlaybookCitiusTech
The healthcare industry has made significant strides across the care continuum, but incomplete and poor data quality still remains a challenge. In this brief playbook, we share key challenges, important quality checks, and a 4 step approach to enhance data quality.
Data Entry India Outsource's article on 5 best practices to ensure effective data quality management and a focused plan for data governance. For more info - https://www.dataentryindiaoutsource.com/blog/5-best-practices-effective-data-quality-management/
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Almost all the regulatory bodies are expected to have Risk Based Quality System. Quality Risk and its assessment has tremendous output and benefits towards the Patient Safety.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
It is difficult to maintain the sterility and It is more difficult to investigate when the status is Non sterile. So this ppt narrate the way for you to investigate the Non sterility.
Solvent plays a crucial role in the reaction. So we should smartly work with solvent. This presentation tries to summarizes the role as well as the effects of the solvent on the different reactions.
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
In the Pharmaceutical, We can get accurate result of the whole population or Whole Batch only and only if Our Sampling Method is perfect and Accurate.
Sampling is also one of the IMP technique for the Statistical calculations.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
In Industry there are lots failures related to the routine process, Equipment and System by one or other means.
So one must analyze control such failures in manner that it will not affect your ultimate output and obviously that is your Product and its Quality.
It is real Art and Talent to make an effective Standard Operating procedure and understanding of the difference between guideline and SOP.
SOP should tell itself
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
4. Some of the Observations
4
Equipment Operator Share password of Admin/Supervisor to change the recipe
parameters for operating equipment.
Person doing calibration of weighing balance without placing actual weight and fill
the record.
Analyst generate the testing record for stability without testing the samples at
defined interval.
Aseptic operation performed using aseptic gowning although gowning sterilization
cycle not executed.
If you do not have documents, You have not done it.
If you have documents, It should not have DIB
10. 10
Metadata
Metadata is the contextual information required to understand data.
A data value is by itself meaningless without additional information about the data.
Metadata is structured information that describes, explains, or otherwise makes it
easier to retrieve, use, or manage data.
For example, the number “23” is meaningless without metadata, such as an
indication of the unit “mg.” Among other things, metadata for a particular piece of
data could include a date/time stamp for when the data were acquired, a user ID of
the person who conducted the test or analysis that generated the data, the
instrument ID used to acquire the data, audit trails, etc.
11. Why Data Integrity is Important ?
11
Undermines the safety and efficacy and/or assurance of quality of the drugs that
consumers will take.
Data integrity problems break trust.
We rely largely on trusting the firm to do the right thing when no one is seeing.
Data Integrity Issues Means Fraudulence
‘Veterinary Social Business Division’.
Hester shall further embark on similar financially sustainable models
through this new division, to serve the backyard and small animal holder
farming in rural India.
12. 12
Paper requirements = Electronic requirements
The requirement for retention and review do not differ
Depending on data format. Paper format and Electronic data format
Are subjected to same requirement
13. 13
Consequences of Data Integrity
BIG LOSS
Loss of Trust
Recalls
Form -483
Warning or Untitled Letter
Import Alert
Injection
Seizure
Application Integrity Policy Invocation
Non Compliance Report
Notice of Concern
Loss of job
Loss of Business
Loss of Money
17. “Firms should implement meaningful and effective strategies
to manage their data integrity risks based upon their process
understanding and knowledge management of technologies
and business models.”
17
www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
USFDA : 21 CFR 211 GMP regulations
19. “Data integrity is fundamental in a pharmaceutical quality system which
ensures that medicines are of the required quality. This document provides
MHRA guidance on GMP data integrity expectations for the pharmaceutical
industry. This guidance is intended to complement existing EU GMP, and
should be read in conjunction with national medicines legislation and the
GMP standards published in Eudralex volume 4.“
19
MHRA GMP Data Integrity
Definitions and Guidance for Industry January 2015
20. 20
Data
Raw Data
Metadata
Data integrity
Data Governance
Data lifecycle
Primary Record
Original Record
Computer System Transaction
MHRA Guideline Data Integrity
Audit Trail
Data Review
Computerized System
User Access/Admin role
Data retention
Data Archival
Data Back Up
Relational Database
Validation
21. 21
EU GMP : Eudralex
The rules Governing Medicinal Products in the European Union
Volume 4 : Annexure 11 : Computerized Systems
27. Not recording activities contemporaneously
Backdating
Fabricating data
Copying existing data as new data
Re-running samples
Discarding data
Releasing failing product
Testing into compliance
Not saving electronic or hard copy data
27
What Auditor Look for DI
Data Integrity for SISPQ
Safety
Integrity
Strength
Purity
Quality
28. Attributable — who acquired the data or performed an action and when?
Legible — can you read the data and any laboratory notebook entries?
Contemporaneous — documented at the time of the activity
Original — written printout or observation or a certified copy thereof
Accurate — no errors or editing without documented amendments
Complete — all data including any repeat or reanalysis performed on the
sample
Consistent — all elements of the analysis, such as the sequence of events,
follow on and are dated or time stamped in expected sequence
Enduring — not recorded on the back of envelopes, packets, Post-it notes or
the sleeves of a laboratory coat, but in laboratory note books and / or
electronic media in the CDS or LIMS
Available — for review and audit or inspection over the lifetime of the
record
28
Criteria for Integrity of data
ALCOA + - GDP
29. 29
Barriers to Complete Data
Biggest Barrier : Working Culture
However data integrity and the lack of complete data over the record retention period
compromised in a number of ways such as :
• Human Errors
When data is entered by mistake (an uncorrected fat finger moment)
Stupidity (not being aware of regulatory requirements or poor training) or
Willfully (falsification or fraud with intent to deceive)
• Selection of good or passing results to the exclusion of those that are poor failing
• Unauthorized changes to data made post-acquisition
• Errors that occur when data is transmitted form one computer to another
• Changes to data through software bugs or malware of which the user is not aware
• Hardware malfunctions, such as disk crashes
• Changes in technology where one item is replace when it becomes obsolete or no
longer supported, making old records unreadable or inaccessible
30. 30
Barriers to Complete Data
According to the FDA, the following are possible data integrity problems in the
laboratory that have been observed in the past :
Alteration of raw, original data and records (e.g., the use of correction fluid)
Multiple analyses of assay with the same sample without adequate
justification
Manipulation or a poorly defined analytical procedure and associated data
analysis in order to obtain passing results.
Backdating stability test results to meet the required commitments
Creating acceptable test results without performing the test
Using test results form previous batches to substitute testing for another
batch
Raw Data Manipulation
31. 31
Data Integrity – Rebuilding Trust
Know the Regulations & Intensity of Data Integrity
Perform a GAP Analysis
Determine the scope of the problem / Detect the integrity
Implement a corrective action plan (global) & Prevent the Integrity
Remove Individuals responsible for problems from CGMP positions
Complete a satisfactory inspection
32. 32
Detecting & Preventing Data Integrity Issues
Increase the frequency of review.
Do surprise / spot checks.
Have a procedures & Check list for review mechanism.
Compare hand writing styles / signatures.
Verify attendance / presence of the person.
Verify the traceability & log book entries.
Internal / External audits.
Trend the observations & provide the training
33. 33
Policies Procedures
Define a clear policy / procedure on various activities (e.g. Password policy)
Have clear procedure and controls over the electronic data / software
administration
Cross check Privileges Vs. Job responsibilities
Check the adequacy of the procedures.
34. 34
Strategic Planning
Determine the level of compliance that we are seeking
Identity the weakness and strengths in our computerized systems.
Conduct an inventory of our systems
Determine if the system must comply with part 11
Conduct the assessment using a checklist or spreadsheet
Provide documented Justification if certain system are exempt from Part 11
Implement and execute a remediation plan
Conduct the required follow-up as warranted
35. Quality Culture
Data Integrity issues
occur and are identified
by auditors as a direct
result of poor quality
culture within
organizations.
Quality Culture needs to
be promoted throughout
the whole organization.
35
37. 37
New Approach to Audit
Focus – Potential for fraudulent activity within your quality systems.
Assumptions : Will assume fraudulent activity is taking place if they identity
weaknesses in your quality systems.
“Guilty until proven innocent” approach to auditing! ‘
“Data to good to be true!”
38. 38
New Approach to Audit
Electronic data (Meta data) is preferred choice for regulatory authorities as this is
the original (“official”) data.
Mete data = data about data
Meta data is dynamic and can be queried / searched / trended.
There is a much higher probability of identifying fraudulent activity within an
organization if meta data is reviewed.
Hard copy (Flat data – printed, pdf, photocopy) is no longer considered to be
acceptable by regulatory authorities as this data is not complete and not original
If you state that paper is your raw data in your internal procedures this will alert an
auditor that you are probably not managing and reviewing electronic (meta) data
39. New Approach to Audit
5 key Data Integrity (DI) questions
Is electronic data available
Is electronic data reviewed
Is meta data (audit trails) reviewed regularly
Are there clear segregation of duties.
Has the system been validated for its intended use
The answers to the above questions will determine whether companies are
in compline with 21 CFR part 11 (Electronic records and signatures)
Leave the Original Meta data in the CDS and review / approval
electronically to avoid increased Data Integrity risk (the paperless lab)
39
40. 40
• The auditor will expect a suite of SOP’s to be in place to support Data
Integrity and minimize risk within your company
• Examples of typical SOP’s include
IT policies
System administration (CDS access, roles and privileges)
Data management and storage
Data acquisition and processing
Data review and approval
Data archiving and back-up
Anti-Fraud monitoring
41. IT : Password, Backup, Disaster Recovery, Date & Time
Administration : Levels of Access, No sharing password policy, Password change
frequency, Audit trail
Data Management : Data Archiving, Data Storage, Data protection
Data Processing : Avoidance of Multiple Processing, Save all the changes
Internal & External Data review : Review Checklist & Methodology
Anti Fraud Monitoring : Anti fraud or DI Officers, Anti fraud Audit
41
FDA Inspectors have been trained by Data Integrity and CDS experts!
They have detailed knowledge of your CDS and know
where to find the meta data to identify if fraudulent activity has taken place!
42. SHORT & SWEET LESSION
42
UNDERSTAND
REGULATORY
REQUIREMENT
DO
THE
GAP ANALYSIS
FILL THE GAP
OR
JUSTIFICATION