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Data Integrity Services

ITS offers a range of data integrity services including data integrity consultancy, data integrity assessments and data integrity remediation services.

Data Integrity Consultancy

ITS has a team of data integrity validation experts that specialises in offering data integrity consultancy, to help companies to understand the regulatory requirements.

Data Integrity Assessments

ITS has extensive experience in carrying out data integrity assessments and identifying gaps in processes. Using a tool kit developed by our team for data integrity, 21 CFR Part 11, security and audit trail assessments, ITS’ validation experts ensure that all aspects of the systems and processes are covered by the assessments. Once the assessments are complete, ITS provides a report outlining the findings, pragmatic recommendations and the remediation actions required to close the gaps.

Data Integrity Remediation Activities and Services

Upon completion of the data integrity assessments, ITS can offer the necessary resource(s) to complete the required remediation activities to meet the data integrity regulatory requirements. Our experience covers a vast range of processes and equipment in manufacturing, packaging, and laboratory facilities.

ITS’ data integrity services cover the following:

  • Assistance in meeting ALCOA requirements
  • Completion of data integrity remediation actions
  • Implementation of audit trail solutions for tracking the creation, modification, or deletion of data (such as processing parameters and results) and tracking actions at the record or system level
  • Provision of system security solutions
  • Delivery of training and education packages to ensure that all levels of an organisation have a good understanding of the data integrity requirements