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Quality Management System at Pharmaceutical Industry

Quality Management is a comprehensive concept that encompasses all aspects that individually or collectively influence product quality. It includes Good Manufacturing Practice (GMP) which ensures medicines are consistently manufactured and controlled to achieve quality standards suitable for their intended use. Quality Control is part of GMP and includes sampling, specifications testing, and documentation to ensure required and relevant testing is conducted and products meet quality requirements before release or distribution. Quality Risk Management is a key enabler used throughout the product lifecycle as part of an integrated Quality Management approach.
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0% found this document useful (0 votes)
136 views85 pages

Quality Management System at Pharmaceutical Industry

Quality Management is a comprehensive concept that encompasses all aspects that individually or collectively influence product quality. It includes Good Manufacturing Practice (GMP) which ensures medicines are consistently manufactured and controlled to achieve quality standards suitable for their intended use. Quality Control is part of GMP and includes sampling, specifications testing, and documentation to ensure required and relevant testing is conducted and products meet quality requirements before release or distribution. Quality Risk Management is a key enabler used throughout the product lifecycle as part of an integrated Quality Management approach.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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KNOWLEDGE SHARING

QUALITY MANAGEMENT SYSTEM


IN PHARMACEUTICAL INDUSTRY
BPOM Workshop

Bandung, May 2023

rakhmat.yuwono@id.etanabiotech.com
+62 08121874839
Term
Learning Matrix
70 : 20 : 10 Model
“Our Discussion”
…recent story in pharmaceutical industries
and some stories before ...

The Elixir Contamination in


Contamination in
Sulfanilamide Sulfathiazole Thalidomide
Isosorbide Tablet
Disaster Tablet
• 1937 • 1940 • 1960 • 2012
• Use of • Contaminated • Teratogenic • Contaminated
Diethyleneglycol by • 10 – 15 by
as Solvent of Phenobarbital thousand cases Pyrimethamine
Sulfanilamide • 300 Death in baby-born – Anti Malaria
• Toxic • 50 % Death • 100 death,
• 107 Death thousands
hospitalized
What’s in common ?
THE PRODUCT ARE……
“COMPLY WITH IT’S SPECIFICATIONS”
…..BUT IT WAS LETHAL
a reminder …
We are in the industry to manufacture LIFE
SAVING, CURING and PAIN MITIGATING
pharmaceutical products

…where there is NO ROOM for ERROR , NO


SECOND CHANCE if something goes wrong and
the incorrect medicine is delivered to the ailing
patient so it can be a question of people’s life

And that patient could be us, our family members


or our friends.
a reminder …

“obat adalah produk yang digunakan oleh


konsumen hanya berdasarkan ASAS PERCAYA
karena mutu produk tidak dapat ditentukan
oleh pasien sebelum produk digunakan …..

BERBAHAYA jika terjadi kesalahan”

….the trust is in “our” hand…


Each & Every
It is the responsibility of EACH and
EVERY member of the
pharmaceutical fraternity to deliver
drugs that ensure Efficacy,
Quality and Safety in
… EACH and EVERY unit of our
batches,
… EACH time and EVERY time

Patient Patient Patient

Pharmaceutical Technology Commercial Product


Development Transfer Manufacturing Discontinuation
How to Achieve ?

… there must be a comprehensively designed and


correctly implemented Pharmaceutical Quality System
incorporating Good Manufacturing Practice and Quality
Risk Management – PIC/S. 2022

… diperlukan Sistem Mutu yang didesain secara


komprehensif dan diterapkan secara benar serta
mencakup Cara Pembuatan Obat yang Baik dan
Manajemen Risiko Mutu – CPOB. 2018
Quality Management - Scope

GLP GLP - Good GCP - Good Clinical


Laboratory Practices Practices

GVP GCP

GMP - Good
Practices GRP - Good
Manufacturing
Regulatory Practices
Practices
GDP GRP

GMP GVP - Good


GDP - Good
Pharmacovigilance
Distribution Practices
Practices

Pharmaceutical Technology Commercial Product


Development Transfer Manufacturing Discontinuation
Regulatory - CPOB
Pedoman CPOB Edisi 2018
Bab I : Sistem Manajemen Industri Farmasi
Regulatory - CPOB
Pedoman CPOB Edisi 2018,
Bab I : Sistem Manajemen Industri Farmasi
Regulatory – EU GMP
EU Guideline for GMP, Chapter I : Pharmaceutical Quality
System
Regulatory – WHO GMP
Annex 2 WHO Technical Report Series, No. 986, 2014, Good
Manufacturing Practices for Pharmaceutical Products:
Philosophy – Responsibility

FIT FOR THEIR


INTENDED USE Responsibility
▪ Pharmaceutical Industry
▪ Supplier
▪ Distributor

DRUG

COMPLY TO
MARKETING DO NOT PLACE
AUTHORISATION PATIENTS AT
OR CLINICAL RISK
TRIAL
AUTHORIZATION
Inadequate
▪ Safety
▪ Quality
▪ Efficacy
Philosophy – Responsibility

• Manajemen puncak bertanggung jawab untuk


pencapaian sasaran mutu, yang memerlukan partisipasi
dan komitmen dari personel pada semua tingkat di
berbagai departemen dalam perusahaan, juga pemasok
dan distributor
• Tambahan tanggung jawab legal diberikan kepada
pemegang Izin Industri Farmasi (IIF) dan kepada
Pemastian Mutu
• Ketersediaan personel yang kompeten, bangunan dan
sarana serta peralatan yang cukup dan memadai.
• Kepala Bagian Pemastian Mutu memiliki tambahan
tanggung jawab secara hukum
“Quality – Update, Paradigm
& Trends”
Trend in Quality

▪ Pada pembuatan obat, pengendalian menyeluruh


adalah sangat esensial untuk menjamin bahwa
konsumen menerima obat yang bermutu tinggi.
▪ Pembuatan secara sembarangan tidak dibenarkan
bagi produk yang digunakan untuk menyelamatkan
jiwa, atau memulihkan atau memelihara Kesehatan
▪ Tidaklah cukup bila produk jadi hanya sekedar lulus
dari serangkaian pengujian, tetapi yang lebih penting
adalah bahwa mutu harus dibentuk ke dalam produk
tersebut
Trend in Quality

▪ Moving from :
✔ Testing Final Product to Building into Product
✔ QC to QA
✔ Quality by Test to Quality by Design
▪ Beyond Compliance and moving to Quality
Culture
▪ Utilize modern science throughout product
lifecycle
▪ Quality Risk Management is a key enabler
throughout product lifecycle
Trend in Quality

▪ Knowledge Management assure the quality


throughout product lifecycle
▪ Integrated approach to development,
manufacturing and quality for both industry and
regulators
▪ Ultimate goal is Patient Oriented / Patient
Protection
Do you know ?

Which is CORRECT ?
a. GMP is part of Quality Assurance
b. Quality Assurance is part of the GMP
What is Quality Management ?
▪ Suatu konsep luas yang mencakup semua aspek baik secara
individual maupun secara kolektif, yang akan memengaruhi
mutu produk. Manajemen Mutu adalah totalitas semua
pengaturan yang dibuat, dengan tujuan untuk memastikan
bahwa obat memiliki mutu yang sesuai tujuan penggunaan.
Oleh karena itu Manajemen Mutu mencakup juga CPOB -
CPOB, 2018
▪ A wide-ranging concept, which covers all matters, which
individually or collectively influence the quality of a product. It is
the sum total of the organised arrangements made with the
objective of ensuring that medicinal products are of the quality
required for their intended use. Quality Management therefore
incorporates Good Manufacturing Practice – PIC/S, 2022
What is Quality Management ?
▪ CPOB adalah bagian dari Manajemen Mutu yang memastikan
obat dibuat dan dikendalikan secara konsisten untuk
mencapai standar mutu yang sesuai dengan tujuan
penggunaan dan persyaratan Izin Edar, Persetujuan Uji Klinik
atau spesifikasi produk. CPOB mencakup Produksi dan
Pengawasan Mutu- CPOB, 2018
Unsur Dasar Manajemen Mutu
▪ Suatu infrastruktur atau sistem mutu Industri Farmasi
yang tepat mencakup struktur organisasi, prosedur,
proses dan sumber daya; dan
▪ Tindakan sistematis yang diperlukan untuk
mendapatkan kepastian dengan tingkat
kepercayaan yang tinggi, sehingga produk (atau jasa
pelayanan) yang dihasilkan akan selalu memenuhi
persyaratan yang telah ditetapkan. Keseluruhan tindakan
tersebut disebut Pemastian Mutu..
Unsur Dasar Manajemen Mutu

Infrastruktur / Tindakan
Sistem Mutu Sistematis
• Struktur • Kepastian
Organisasi • Tingkat
• Prosedur Kepercayaan
• Proses Tinggi
• Sumber Daya • Produk Selalu
Memenuhi
Persyaratan
What is GMP ?
▪ CPOB adalah bagian dari Manajemen Mutu yang memastikan
obat dibuat dan dikendalikan secara konsisten untuk
mencapai standar mutu yang sesuai dengan tujuan
penggunaan dan persyaratan Izin Edar, Persetujuan Uji Klinik
atau spesifikasi produk. CPOB mencakup Produksi dan
Pengawasan Mutu- CPOB, 2018
What is Quality Control ?
▪ Pengawasan Mutu adalah bagian dari CPOB yang mencakup
pengambilan sampel, spesifikasi dan pengujian, serta
mencakup organisasi, dokumentasi dan prosedur pelulusan
yang memastikan bahwa pengujian yang diperlukan dan
relevan telah dilakukan. Bahan tidak boleh diluluskan untuk
digunakan dan produk tidak boleh diluluskan untuk dijual atau
didistribusi sampai mutunya dinilai memuaskan - CPOB, 2018
Quality Management, Good Manufacturing
Practice and Quality Risk Management
…konsep dasar
Manajemen
Mutu, Cara
Pembuatan
Obat yang Baik
(CPOB), dan
Manajemen
Risiko Mutu
adalah saling
terkait...
Quality System – what should ensure ?
▪ Realisasi produk diperoleh dengan mendesain,
merencanakan, mengimplementasikan, memelihara Quality Manual
dan memperbaiki sistem secara berkesinambungan
sehingga secara konsisten menghasilkan produk dengan
atribut mutu yang tepat Technology
Transfer
▪ Product and process knowledge is managed throughout
all lifecycle stages
▪ Products are designed and developed in a way that takes Document
Management
account of the requirements of GMP, GLP and GCP
▪ Production and control operations are clearly specified
in a written form and GMP requirements are adopted. Production
Quality System – what should ensure ?
▪ Arrangements are made for the manufacture, supply and use of
the correct starting and packaging materials, the selection and
monitoring of suppliers and for verifying that each delivery is the
correct material from the approved supply chain
Third Party
Management Quality Control
/Supplier
Qualification
Quality System – what should ensure ?
▪ Products are not sold or supplied before the Batch Record
authorized persons have certified that each Review &
Product
production batch has been produced and controlled Release
in accordance with the requirements of the
marketing authorization and any other regulations Storage &
Distribution
relevant to the production, control and release of
pharmaceutical products.
▪ Satisfactory arrangements exist to ensure, as far as Production
possible, that the pharmaceutical products are
stored, distributed and subsequently handled so
that quality is maintained throughout their shelf-
life Quality Control
Quality System – what should ensure ?
▪ Regular reviews of the quality of pharmaceutical products are
conducted with the objective of verifying the consistency of the
process and identifying where there is a need for improvement;
▪ There is a system for QRM;

Product Quality
Review Quality Risk Management
Quality System – what should ensure ?
▪ Deviations, suspected product defects and other problems are
reported, investigated and recorded. An appropriate level of root
cause analysis is applied during such investigations. The most
likely root cause(s) should be identified and appropriate corrective
actions and/or preventive actions (CAPAs) should be identified
and taken. The effectiveness of CAPAs should be monitored.

Handling of
CAPA
Deviation
Quality Management System
Batch Record
Management Validation,
Quality Review &
Commitment/ Quality Manual Qualification &
Organization Product
Quality Policy Calibration
Release

Producy Document
Handling of Storage &
Product Recall Complaint & Management
Deviation Distribution
Return

Third Party
Banguna dan Management
Personnel Peralatan Production
Saranan /Supplier
Qualification

Internal/Extern
Quality Control CAPA Change Control Stability Study
al Audit

Product Quality Technology Sanitation & Environment


Training
Review Transfer Hygiene Monitoring

Quality Risk Management


Quality Policy & Quality Manual
▪ Senior management should establish a quality policy that
describes the overall intentions and direction of the company
related to quality and should ensure continuing suitability and
effectiveness of the Pharmaceutical Quality System and GMP
compliance through participation in management review –
PIC/S, 2022
▪ Sistem Mutu Industri Farmasi seharusnya ditetapkan dan
didokumentasikan. Manual Mutu atau dokumentasi setara
seharusnya ditetapkan dan mengandung deskripsi sistem
manajemen mutu termasuk tanggung jawab manajemen –
CPOB, 2018
▪ A Quality Manual :
(a) The quality policy
(b) The scope of the pharmaceutical quality system.
(c) Identification of the pharmaceutical quality system
processes.,
(d) Management responsibilities within the pharmaceutical
Change Control
▪ Arrangements are in place for the prospective evaluation of
planned changes and their approval prior to
implementation taking into account regulatory notification
and approval where required – PIC/S, 2022
▪ Any change - during the whole lifecycle of the product or
process, which can affect a product or a GxP System, process
or organization must follow a formal change control
process.
▪ The change control process requires identification,
documentation, appropriate evaluation, and approval of
changes to ensure quality, efficacy, and safety of the product
and to fulfil the regulatory requirements for change
reporting
▪ The impact of the changes on the regulatory dossier must
be evaluated as part of the change control.
▪ Changes with regulatory impact must be communicated to
Regulatory Authorities according to the requirements
Deviation and CAPA
▪ Appropriate corrective actions and/or preventive actions
(CAPAs) should be identified and taken in response to
investigations – PIC/S, 2022
▪ Setiap penyimpangan signifikan dicatat dengan lengkap,
diinvestigasi dengan tujuan untuk menentukan akar masalah
dan pelaksanaan tindakan korektif dan tindakan pencegahan
yang tepat – CPOB, 2018
▪ All Deviation have to identify, record and investigate and to
identify the most probable root causes and to implement the
necessary corrective and preventive actions, when a product,
material or system fails to meet a specification or to comply
with relevant documentation or regulatory requirements
▪ The level of efforts, formality, and documentation for
deviation investigations must be commensurate with the
significance of the issue or problem
Data Integrity –Basic Principles
How To Implement QMS – experience based
Know the
Policy,
requirement or
Risk Control Procedures, Work
applicable
Instruction
regulation

Risk Analysis & Personnel


Gap Analysis
Evaluation Training

Management
Risk Continuous
Review (incl.
Identification Monitoring
Stakeholders)

Patient Product
Product Regulatory
Safety &
Quality Compliance Avaiability
Efficacy
KNOWLEDGE SHARING
QUALITY RISK MANAGEMENT
MANAJEMEN RISIKO MUTU
Why Important & Critical
▪ Manufacturing and use of a drug product involve some
degree of risk.
▪ Effective Quality Risk Management (QRM) ensure the high
quality of the drug product
✔ Proactive means to identify and control potential
quality issues
✔ improve the decision making if a quality problem
arises.
✔ facilitate better and more informed decisions
▪ Provide regulators with greater assurance of a company’s
ability to deal with potential risks and might affect the
extent and level of direct regulatory oversight
Why Important & Critical
▪ Improves decision making
▪ Identifies what gives most benefit to the patient
▪ Is scientific & data-driven
▪ Reduces subjectivity
▪ Ranks risk - allows prioritization
▪ Better use of resources
▪ Means of building in Quality
▪ Gives a company the ability to maintain compliance and
identifying product issues that could be harmful to
patients.
▪ Improves transparency - inside organisation and builds
trust with competent authorities
▪ Enables regulatory flexibility 45 | Q-Risk
Management | April
Learning Matrix

*) PDA TR 54 “Implementation of Quality Risk Management for Pharmaceutical


and Biotechnology Manufacturing Operations”, 2012
What is the RISK ?

Risk - ISO Risiko - CPOB


The combination of the Kombinasi kemungkinan
probability of terjadinya kejadian
occurrence of harm and yang membahayakan serta
the severity of that harm tingkat keparahan
bahaya tersebut.

Harm - ICH Keparahan - CPOB


Damage to health, Kerusakan bagi
including the damage that kesehatan, termasuk
can occur from loss of kerusakan yang dapat
product quality or terjadi akibat penurunan
availability mutu atau ketersediaan
produk
What is Quality Risk Management ?

Quality Risk Management - ICH Q9


A systematic PROCESS for the assessment, control,
communication and review of risks to the quality of
the drug product across the product lifecycle.

Manajemen Risiko Mutu - CPOB


Manajemen Risiko Mutu adalah proses sistematis
untuk menilai, mengendalikan, mengkomunikasikan,
dan mengkaji risiko terhadap mutu produk jadi
sepanjang siklus-hidup.
.
Basic Principles

1. The evaluation of the risk to


quality should be based on
scientific knowledge and Scientific
Knowledge
ultimately link to the protection Patient
Protection

of the patient; and


2. The level of effort, formality and Level of
Risk
documentation of the quality
risk management process should
be commensurate (equal,
proportional, adequate) with the
level of risk Risk Management
Quality Risk Management – Life Cycle

Risk Assessment

Risk Control
Risk Review
Risk Communication
Risk Assessment - Process

▪ Risk assessment consists of


the identification of hazards
and the analysis and
evaluation of risks associated
with exposure to those
hazards.
▪ Risk assessments begin with
a well-defined problem
description or risk question.
1. What might go wrong?
2. What is the likelihood
(probability) it will go
wrong?
3. What are the
consequences (severity)?
51 | Q-Risk
Management | April
Risk Identification

▪ Risk Identification is a
systematic use of information
to identify hazards referring to
the risk question or problem
description.
▪ Information : historical data,
theoretical analysis, informed
opinions, and the concerns of
stakeholders.
▪ Addresses the “What might go
wrong?” question, identifying
the possible consequences.
▪ Provides the basis for further
steps in the quality risk
management process.
52 | Q-Risk
Management | April
Risk Analysis

▪ Risk analysis is the


estimation of the risk
associated with the identified
hazards.
▪ Qualitative or quantitative
process of linking the
likelihood of occurrence and
severity of harms.
▪ In some risk management
tools, the ability to detect the
harm (detectability) also
factors in the estimation of
risk.

53 | Q-Risk
Management | April
Risk Evaluation

▪ Risk Evaluation compares the


identified and analyzed risk
against given risk criteria. Risk
evaluations consider the
strength of evidence for all three
of the fundamental questions.

54 | Q-Risk
Management | April
Risk Evaluation - Output

▪ The output :
✔ quantitative estimate of
risk with a numerical
probability range of risk
✔ qualitative description
using qualitative
descriptors, such as
“high”, “medium”, or
“low”

55 | Q-Risk
Management | April
Risk Control - General

▪ Includes decision making


to reduce and/or accept
risks.
▪ Purpose is to reduce the
risk to an acceptable level.
▪ The effort should be
proportional to the
significance of the risk.
▪ Risk control might focus
on the following questions:
▪ Is the risk above an
acceptable level?
▪ What can be done to
reduce or eliminate
risks?
▪ What is the appropriate
balance among
56 | Q-Risk
benefits, risks and| April
Management
Risk Reduction

▪ Focuses on processes for


mitigation or avoidance of
quality risk when it exceeds a
specified (acceptable) level.
▪ Might include actions taken to
mitigate the severity and
probability of harm.
▪ Processes that improve the
detectability of hazards and
quality risks might also be
used as part of a risk control
strategy.
▪ Implementation can introduce
new risks into the system or
increase the significance of
other existing risks - might be
appropriate to revisit the 57
risk
| Q-Risk
Management | April
Risk Management Tools

▪ Failure Mode Effects Analysis (FMEA)


▪ Failure Mode, Effects and Criticality Analysis
(FMECA)
▪ Fault Tree Analysis (FTA)
▪ Hazard Analysis and Critical Control Points
(HACCP)
▪ Hazard Operability Analysis (HAZOP)
▪ Preliminary Hazard Analysis (PHA)
▪ Risk Ranking and Filtering
▪ Supporting statistical tools

58 | Q-Risk
Management | April
Be Aware …

▪ QRM do not a means of removing industry’s


obligation to comply with regulatory
requirements
✔ Justification of product or process failures
▪ People have to think and not simply follow black
and white rules
▪ Pre-determined outcome of assessments
▪ Not applicable in situations where decisions
allow no flexibility (regulatory requirements)
▪ Not embedded in an overall quality systems,
stand alone activity
Be Aware …

▪ Lack of training on tools


▪ Improper composition of teams performing the
risk assessments – lack of scientific knowledge,
relevant data not assessed, lack of process
knowledge
▪ Decision makers and stakeholders not informed
▪ Writing half of (or hiding) facts or information
▪ Hiding the risk
▪ Reduce workload or resources inappropriately
(no scientific and reasonable justification)
Be Aware …

Do not know the Risk



No Risk

Is it a RISK ?
YES (if we know that)….
SUPPORTING SLIDES
KNOWLEDGE SHARING

DATA INTEGRITY
IMPORTANT & CRITICALITY
Why Important – Background ?
▪ Regulatory agencies have cited deficiencies in GMP data
integrity and data management for at least the past 15
years.
▪ It appears that the industry as a whole has made
limited progress in self identifying and remediating
these deficiencies.
▪ Regulators continue to identify the same set of
shortcomings including, but not limited to:
✔ shared passwords,
✔ lack of enabled audit trails,
✔ failure to review electronic data,
✔ failure to review and investigate all failed testing
results and failure to contemporaneously record
information.
Tianjin Zhongan Pharmaceutical
Tianjin Zhongan Pharmaceutical Co., Ltd.
“Failure to adequately complete and follow written procedures for
cleaning equipment and its release for use in API manufacture, and
to maintain adequate records of major equipment usage”
…failed to ensure that employees adequately cleaned after use. Your
equipment cleaning standard operating procedures require that
employees visually inspect equipment after the cleaning process. Our
inspection found in the manufacturing workshop for with various
levels of contamination and foreign objects inside, including what
looked like the remains of a pen in one of the (b)(4). Your employees
had labeled this equipment as clean. These are used for the
manufacture of multiple APIs.
… production system did not maintain equipment logs or other
documents that adequately record manufacturing operations
performed on individual pieces of equipment.
We note that your production operation supervisors and Quality Unit
(QU) failed to detect and correct these deficient cleaning practices
Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited
…missing the fundamental raw data and information necessary to
document your analyses. These analyses lack the following critical data:
• identification of the samples tested, including name and source, batch
number or other distinctive code, and date of the sample
• the complete record of all raw data generated during each test,
including graphs and electronic files from laboratory instrumentation
• test method used
• sample preparation as prescribed by the method, preparation and
testing of standards, reagents and standard solutions
• records of all calculations performed in connection with the test
• test results
• the signature of the person who performed each test and the date(s)
the tests were performed, and the date and signature of a second
person showing that the original records have been reviewed for
accuracy, completeness, and compliance with prescribed acceptance
criteria
Sun Pharmaceutical Industries Limited
…frequently performs “unofficial testing” of samples, disregards the
results, and reports results from additional tests. For example, during
stability testing, your firm tested a batch sample six times and
subsequently deleted this data.
Our investigators found your practice of performing initial “trial” sample
high performance liquid chromatography (HPLC) analyses prior to
acquiring the “official” analyses. The “trial” sample results were
subsequently discarded. Senior QC Officer confirmed that QC laboratory
employees had frequently practiced the use of “trial” injections at your
facility. Significantly, in addition to the example above, our inspection
found 5,301 deleted chromatograms on a computer used to operate two
HLPC instruments in your QC laboratory. Many of these files were “trial”
injections of batches
…similar unacceptable data handling practices were observed in your
laboratory’s conduct of gas chromatography (GC) analyses. The FDA
investigators reviewed what appear to be data from “unofficial” injections
for GC analyses for recovered raw material batch #(b)(4)…therefore, it
appears that out-of-specification data for batch #(b)(4) was considered to
be “unofficial,” while passing data were reported as the "official" results
Why Important ?
Why Important ?
Why Important ?
Why Important ?
Breaches of Data Integrity (BDI)
Data Integrity – Why fraud or breach ?
Data Integrity – Why fraud or breach ?
Data Integrity –Basic Principles
Data Integrity –Basic Principles
What is being challenged by Agency ?
Data Integrity –Basic Principles

A Attributable Who performed the action & Who performed?


when? Record change, who did it Source Data
and why?

L Legible Data must be recorded Can you read it?


permanently in durable medium & Permanent record
be readable

C Contempora Data should be recorded at the Was it done in real


neous time the work is performed and time?
date /time should follow in order

O Original Is the information an original Is it original or true


record or certified true copy? copy?

A Accurate No error or editing performed Is it accurate?


without documented amendments
Data Integrity –Basic Principles
Data Integrity –Basic Principles
Data Integrity –Basic Principles
Data Integrity – take your notes
Thank You

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