Data Integrity Solutions in Pharma

Data Governance System

Data governance is the sum total of arrangements which provide assurance of data integrity. These arrangements ensure that data, irrespective of the process, format or technology in which it is generated, recorded, processed, retained, retrieved and used will ensure a complete, consistent and accurate record throughout the data life cycle.

Verification of Data Integrity Considerations for Paper-Based Systems

  • Generation.
  • Distribution and Control.
  • Completion of records.
  • Varification records.

Verification Data Integrity Considerations for Computerized System

  • Qualification and validation of computerized system.
  • System security for computerized system.
  • Audit trails for computerized system.
  • Data capture/entry for computerized system.
  • Review of data within computerized system.
  • Storage, archival and disposal of electronical data.

Data Integrity Considerations for Outsourced Activities

  • General supply chain considerations.
  • Routine document verification.
  • Strategies for assessing data integrity in the supply chain.

Remediation of Data Integrity Failures

  • Responding to Significant Data Integrity issues.
  • Corrective and preventative actions taken to address the data integrity vulnerabilities and timeframe for implementation.
  • Implementation of data integrity policies in line with the principles.
  • Implementation of routine data verification practices.

Mode of Services

Service A

  • Meeting with client.
  • Make a gap and data integrity assessment, Reconciliation of all discrepancies.
  • Define action plan and execute the plan.
  • Regular visits to make sure the effective implementation of plan.

Service B

  • Meeting with client.
  • Make a gap and data integrity assessment, Reconciliation of all discrepancies.
  • Define action plan and execute the plan.
  • Appoint fulltime Sasaglobal team at the site for agreed period and our team implement all the defined action plan.
  • Execute trainings as per training need identification.
  • Regular visits to make sure the effective implementation of plan.