Data Integrity - Home - Paperless Lab · PDF fileData Integrity Many publications/guidelines...
Transcript of Data Integrity - Home - Paperless Lab · PDF fileData Integrity Many publications/guidelines...
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Data Integrity …
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Data Integrity
Is it a hype ?
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Data Integrity
Many publications/guidelines emerged
- FDA 2016
- MHRA 2016
- PIC/S 2016
- EMA 2016
- WHO 2016
- ISPE 2017
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Data Integrity
Not a hype …
… it has always been vogueand
will always be vogue …
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ITC Validation Consultants… an extra measure of Quality
Frans LeijseManaging Director
Risk based approaches for corporate governance and regulatory compliance
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ITC Validation Consultants… an extra measure of Quality
- Computer Systems Validation- Supplier Audits- IT System selection- Quality System development- Training & Coaching- Risk Management- Security Management- Compliance assessments- Due Diligence
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ITC Validation Consultants… an extra measure of Quality
Risk Based Quality Assurance- Pharmaceutical- Clinical Research (CRO)- Life-Sciences- Health Care- Industry
DARQA (Dutch Association of Research Quality Assurance)
ISPE (International Society for Pharmaceutical Engineering)
GAMP (Good Automated Manufacturing Practices)Vice Chair Benelux COP Steering Committee
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Data Integrity
Bla bla
Bla blaBla bla
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• W• W
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Raw Data and its attributes
0.957
B4OD Sample
0078Study
111-111Test ItemABC123
Metadata Raw Data Element
Date28-Mar-17
OperatorHKL
Well(450 nm)
10:23:49
Analytical method
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Raw Data
Raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study. (OECD No. 1)
e.g.- Histopathological evaluationmeasurements e.g.- Body, organ weight- Bioanalytical analysis
Conformation of followed procedurese.g.- Cage rotations- Water bottle exchange
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Raw Data and Metadata
Raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study. (OECD No. 1)
Metadata: Data that describe the attributes of other data. Most commonly these are data that describe the structure, data elements, inter-relationships and other characteristics of electronic records. (OECD Advisory Document No. 15)
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Audit Trail
0.957
ODSample0078
Study111-111
Test ItemABC123
Date28-Mar-17
OperatorHKL
ABC132typing error
HKL
28-Mar-17
10:25:09
WellB4(450 nm)
10:23:49
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Raw Data – Metadata - Cluster
Each element of the cluster needs to be audit trailed in case of a change
Loss of an element may invalidate the cluster
Relationship should be maintained during the life cycle of the electronic raw data (acquisition, processing, and archiving) – Data Integrity!
0.957
OD (450 nm)Operator
HKL
Sample0078
Test ItemABC123
Study111-111
Date28-Mar-0910:23:49
WellB4
AnalyticalMethod
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Electronic (Raw) Data
Acquisition Processing Archiving
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Data Integrity
That’s all for today folks
Thank you !