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Data Integrity …
Data Integrity
Is it a hype ?
Data Integrity
Many publications/guidelines emerged
- FDA 2016
- MHRA 2016
- PIC/S 2016
- EMA 2016
- WHO 2016
- ISPE 2017
Data Integrity
Not a hype …
… it has always been vogueand
will always be vogue …
ITC Validation Consultants… an extra measure of Quality
Frans LeijseManaging Director
Risk based approaches for corporate governance and regulatory compliance
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
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
Data Integrity
Bla bla
Bla blaBla bla
• W• W
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
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
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)
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
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
Electronic (Raw) Data
Acquisition Processing Archiving
Data Integrity
That’s all for today folks
Thank you !
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