Data Integrity Assurance

Global leader in full product life cycle computer system validation and IT compliance

Data Integrity

Data integrity may expose life science companies to significant regulatory and business risk.
PQE’s multidisciplinary teams allow customers to achieve compliance and the Data Governance System, which is integral to a fully functional Quality System.
The integrity of regulated data relies upon the validation of the computer system responsible for managing regulated data. As a proven global leader on this topic, PQE can support customers in the implementation of a cost effective and feasible validation strategy. This results in the assurance of the systems validation life cycle, which in turn enhances and improves product quality, patient safety and data integrity. PQE’s integrated approach enables client’s data integrity assurance and validation requirements through a scalable and fully regulatory compliant delivery model, based on a robust risk analysis.

Pharma Capabilities
  • Data Integrity Policy
  • Data Integrity Historical Verification
  • ALCOA Assessment
  • Data Integrity Remediation Plans
  • Continuous Monitoring Procedures for Data Integrity
  • Audit Trail Review Methodologies
Medical Devices Capabilities
  • Data Integrity Policy
  • Data Integrity Historical Verification
  • ALCOA Assessment
  • Data Integrity Remediation Plans
  • Continuous Monitoring Procedures for Data Integrity
  • Audit Trail Review Methodologies

Computer System Validation

Computer System Validation has been PQE’s core business since its foundation in 1998. We have an unmatched track record of providing our clients with strategy and execution support with their FDA / EMA / WHO / TGA / SSA / SFDA / ANVISA / INVIMA and other Local Regulatory Body compliance projects.
Our multidisciplinary team, which has extensive years of experience, enables us to support our clients in turnkey validation projects for all types of computerized systems: management information systems, systems from a manufacturing area and applications used in Laboratories.

Pharma Capabilities
  • Computer System Validation Strategy
  • Best Practices for Cost Saving & Quality of 21 CFR Part 11 Compliance Strategy
  • Validation Templates and System Specific Packages
  • Ongoing Adaptation of Risk Based Computer Validation Approach to Current Regulatory Expectations
  • Computer Validation of Global and Local IT Systems (e.g. ERP, LIMS, MES)
  • Laboratory & Process Control Systems Validation
  • CSV Best Practices
  • User Requirements and Process Mapping
  • Data Migration Verification Strategy and Execution
  • System Testing (Unit & Integration Tests, UAT)
  • Validation Test Planning, Execution & Documentation
  • Best Practices Procedures to Maintain the Validated Status
  • Change Management & Periodic Review
  • 21 CFR Part 11 & EU GMP Annex 11 Assessments
  • Risk-prioritized & Turnkey Remediation Projects
  • 21 CFR Part 11 Inspection Readiness Projects
Medical Devices Capabilities
  • Computer System Validation Strategy
  • Best Practices for Cost Saving & Quality of 21 CFR Part 11 Compliance Strategy
  • Validation Templates and System Specific Packages
  • Ongoing Adaptation of Risk Based Computer Validation Approach to Current Regulatory Expectations
  • Computer Validation of Global and Local IT Systems (e.g. ERP, LIMS, MES)
  • Laboratory & Process Control Systems Validation
  • CSV Best Practices
  • User Requirements and Process Mapping
  • Data Migration Verification Strategy and Execution
  • System Testing (Unit & Integration Tests, UAT)
  • Validation Test Planning, Execution & Documentation
  • Best Practices Procedures to Maintain the Validated Status
  • Change Management & Periodic Review
  • 21 CFR Part 11 & EU GMP Annex 11 Assessments
  • Risk-prioritized & Turnkey Remediation Projects
  • 21 CFR Part 11 Inspection Readiness Projects

Regulated IT Solutions

Regulated IT Solutions consists of a multidisciplinary team of professionals with a background in electronic engineering, software development, systems integration and information technology. We are able to offer a broad spectrum of scalable services, thanks to our proven experience in the field of IT solutions, infrastructure qualification and computer systems validation for life science companies.

Pharma Capabilities
  • Assessment of the compliance level of IT processes against international standards and guidelines (Eg. GAMP, NIST, ITIL)
  • IT Infrastructure qualification
  • IT Infrastructure Design & Implementation Project Management
  • Selection and Evaluation of Hardware and Software Suppliers
  • Design and Implementation of Secure WANs
  • Management and Monitoring of System Integrator
  • Design & Management of Server Rooms and Networks
  • Data Housing and Hosting Services
  • Data Archiving and Retrieval
  • ERP Suitability and Gap Analysis
  • Security Standard Assessment
  • General Data Protection Regulation (GDPR)
Medical Devices Capabilities
  • Assessment of the compliance level of IT processes against international standards and guidelines (Eg. GAMP, NIST, ITIL)
  • IT Infrastructure qualification
  • IT Infrastructure Design & Implementation Project Management
  • Selection and Evaluation of Hardware and Software Suppliers
  • Design and Implementation of Secure WANs
  • Management and Monitoring of System Integrator
  • Design & Management of Server Rooms and Networks
  • Data Housing and Hosting Services
  • Data Archiving and Retrieval
  • ERP Suitability and Gap Analysis
  • Security Standard Assessment
  • General Data Protection Regulation (GDPR)