Data Integrity / Software Validation

Industry has shifted from paper to electronic systems in order to record activities and data that support GMP decisions. Electronic systems now generate, manipulate, store, and retrieve this data.

Regulators now expect companies to demonstrate that their electronic data is authentic, to establish controls to prevent and detect falsification of data, and to validate their electronic systems for the intended purpose.

The Electronic systems that data is generated and managed from are therefore very important, require understanding and careful management.

  • Analytical and production equipment
  • Warehouse management systems (WMS)
  • Enterprise resource planning software (ERP) (e.g., SAP)
  • Temperature monitoring systems
  • Building systems (e.g., HVAC, pressure, humidity)
  • Labelling and packaging systems
  • GMP process management systems
  • Cloud-based systems for data storage, e-signatures

Pharmaceutical Fabricators, Packagers, Labellers, Test Laboratories, Importers, Distributors, and Wholesalers.

Anyone conducting GMP activities using electronic systems, and/or relying on data recorded within the systems in order to make, or verify a GMP decision.

Anyone who decides which systems are to be used (IT Professional or QA/QC), their purpose, and how they will be controlled.

  • Understand the system GMP usage and risks to patient and product
  • Purchase appropriately, for the intended use
  • Validate the system for intended use
  • Control the content within the system
  • Verify that the system is being used appropriately
  • Throughout the system and product life cycle

Data Integrity Objectives:

To reduce potential risk to patient and product by effectively protecting electronic systems from potential harm (e.g., Enabling controls)

To ensure that electronic systems protections are effective, and that no risk to patient or product has occurred (e.g., Validating and verifying controls through self-inspection processes

To ensure that evidence is gathered (to a legal standard) that demonstrates the above has been met (e.g., Validation, Auditing)

Data Integrity services we can provide:

  • Computer Equipment Validation
  • Auditing
  • Self-Inspections
  • Training
  • GAP Assessment and Remediation Planning
  • Technical Writing
  • On-Site Consulting
  • Remediation/Audit Responses
  • Quality Leadership
  • Importation
  • Validation of Warehouse Management System

Recent Data Integrity Projects

Qualified IT Infrastructure

A Canadian API fabricator contacted our team regarding an application and hardware validation of their operations. We set to work and our team qualified their IT network infrastructure, deployed and validated a new corporate backup solution, and provided documented associate procedures for system use.