It is important to understand what data integrity really means in order to be compliant. Data integrity is a global mandatory requirement for the regulated healthcare industry. Developing and bringing a medical/Bio-Pharmaceutical product to market involves different players and activities; therefore, robustness and accuracy of the data submitted by manufacturers to regulatory authorities is crucial.

The data must be comprehensive, complete, accurate and true to ensure the quality of studies supporting applications for medical/Bio-Pharmaceutical products to be placed on the market.

Data is expected to be:

  1. Attributable – Data should clearly demonstrate who observed and recorded it, when it was observed and recorded, and who it is about.
  2. Legible – Data should be easy to understand, recorded permanently and original entries should be preserved.
  3. Contemporaneous – Data should be recorded as it was observed, and at the time it was executed.
  4. Original – Source data should be accessible and preserved in its original form.
  5. Accurate – Data should be free from errors, and conform with the protocol.

Complete, consistent, and accurate data must be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

Mivado GP gives support in the following:

  • Data Integrity Governance and Policies;
  • Data Security control and Management;
  • Data Source Control;
  • Cloud Computing and Cybersecurity;
  • Data Storage and Retrieval Assessment;
  • System Level Agreement Evaluation;
  • Business Continuity Plan;
  • Cybersecurity Qualification (CyQ);
  • Data Integrity Maintenance Plan

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