Data integrity is a critical regulatory requirement for the life science industry that is applicable to validation lifecycle. All information data and records generated during validation and the lifecycle of GMP systems is subject to data integrity regulatory requirements. Data integrity refers to the accuracy and consistency of stored data, indicated by an absence of any alteration in data between two updates of a data record. Data integrity is defined as the presence of accurate & reliable data and information. Data integrity requires data and information that is complete, consistent and accurate during its lifecycle.

During validation, a significant amount data and information is generated during the lifecycle of GMP systems that requires data integrity. This data and information includes validation lifecycle data for critical manufacturing equipment, process control systems, laboratory instruments and computer systems. The traditional validation process is paper-based and requires resources to manually enter data and information in protocols, test cases and summary reports. Traditional validation requires a significant amount of procedure controls that are intended to ensure data integrity during the validation lifecycle.

During validation data integrity can be impacted by the following factors:

  • Human errors when data is entered
  • Errors that occur when data is transmitted from one computer to another
  • Backdating data
  • Not recording activities at the time when they are performed
  • Falsifying data
  • Discarding data
  • Unauthorized changes to data
  • Incomplete data

The fact is that data integrity in validation is highly dependent on people following established procedure controls which can be very challenging during the lifecycle of GMP system. The traditional validation process has a significant amount of compliance risk related to data integrity during the lifecycle.

ValGenesis validation lifecycle management system provides the industry top solution that eliminates all the data integrity challenges found in traditional validation. ValGenesis eliminates paper-based records and automates the entire validation process including enforcing procedure requirements using frameworks and decision trees.

ValGenesis provides security, audit trails, and traceability for all actions performed in the system therefore enabling alignment with the following ALCOA principles:

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Trace matrices can be approved through a controlled workflow

ValGenesis is designed to meet all the data integrity requirements defined by global regulatory agencies such as the FDA and MHRA.

About the Author

cloud-sun Ivan Soto is the Director Client Engagement and Product Strategy, he is responsible for managing the product lifecycle, strategy and overall client experience. Ivan Soto has been in the industry for over 20 years, and held several technical and management positions at different Pharmaceuticals companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.
data integrity data integrity validation

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