It is the structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.

Metadata is the contextual information required to understand data.

Such data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).' 'Data integrity refers to the completeness, consistency, and accuracy of data. The management must play a pivotal role by taking steps to offset each of the above factors that cause data integrity deficiencies.Īn important step on the path to data integrity compliance is to understand associated definitions and implement the best practices given in the guidance documents.ĭata Integrity Associated Definitions and Best Practices Errors can occur during data transfer as frequently observed during audits. There are multiple data transfer points such as data from notebooks/worksheets to calculators and back, data from worksheets/notebooks to LIMS, worksheets/notebooks to reports etc. The Pharmaceutical industry data is largely collected manually. MHRA GMP Data Integrity Definitions and Guidance for Industry - March 2015Ĭauses of Data Integrity Violations and Challengesĭespite the many guidance documents and public statements that explain what is expected of the manufacturers, many companies struggle with data integrity deficiencies due to the following reasons:.FDA Draft Guidance, Data Integrity and Compliance with cGMP - April 2016: This guidance provides the Agency's current thinking on the creation and handling of data in accordance with CGMP requirements.Electronic signature and record-keeping requirements.'complete information', 'complete data derived from all tests', 'complete record of all data', and 'complete records of all tests performed'.records be retained as 'original records', 'true copies', or other 'accurate reproductions of the original records'.Certain activities be 'documented at the time of performance' and that laboratory controls be 'scientifically sound'.

Data be 'stored to prevent deterioration or loss'.

'Backup data are exact and complete', and 'secure from alteration, inadvertent erasures, or loss'.

21 CFR 211 and 212 : Requirements with respect to data integrity include, among other things:.

The regulatory requirements for data integrity This article guides FDA regulated companies through the data integrity compliance process. Even an innocent mistake can be perceived as an intentional fraud. Data integrity errors can erode the trust with customers and FDA.

Non-compliance can lead to product seizures, product non-approvals or delays of approvals, import restrictions, substantial fines, disbarment, and criminal liability for individuals or company. This is evident from the number of warning letters and Form 483 inspectional observations at manufacturing sites around the world. Many Companies continue to struggle with basic data integrity problems.