Mastering and controlling GxP data is essential to ensure that data obtained through GxP activities are complete, consistent and precise and thus guarantee decision-making by pharmaceutical industries and laboratories; and the competent authorities.
Data Integrity (DI), according to US FDA, refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). These characteristics are important to ensuring data integrity and are addressed throughout the cGMP regulations for drugs.
Per MHRA, Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle.
Mivado Global Performance provides complete Data Transformation and Integrity services and solutions to the key DI issues and expect actions to achieving a high degree of DI compliance regarding Regulatory Requirements.
Our consultants are ready to support implementing the following DI enablers:
- Quality Risk Management
- Knowledge Management
- Data Life Cycle Management
- Data Governance Policy
- Data Quality Management
- Data Integrity Policy
- Data Control Strategy
- Data Integrity & Compliance
- Good Documentation practices
Data Integrity applies to manual, hybrid and electronic systems. The processes that generate and manage data throughout the product lifecycle must meet regulatory requirements and expectations.
Organization must create a culture and environment fostering the detection, reporting and management of Data Integrity issues. Contact us today!
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