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 !