Data Integrity Solutions
Technical and procedural data-integrity solutions — governance, audit-trail review, access control and ALCOA+ controls.
Overview
Data integrity is central to GMP compliance, and weak governance is a leading cause of regulatory action worldwide. PharmExpert designs and implements data-integrity solutions across systems and processes so records are Attributable, Legible, Contemporaneous, Original and Accurate — plus Complete, Consistent, Enduring and Available.
Where the remediation pillar focuses on assessing and closing findings, this service focuses on the technical, system-level solutions and governance that make data trustworthy by design. We build data-governance frameworks and translate ALCOA+ principles into concrete system controls and operating procedures.
Audit-trail review is a particular focus. Many sites enable audit trails but never review them, or review them in a way that is unsustainable. We design risk-based, practical audit-trail-review programs that actually work day to day, alongside remediated access controls, segregation of duties, and backup and retention controls.
Technology alone does not secure data integrity, so we pair the controls with training and the cultural reinforcement that make review discipline and honest record-keeping the norm. The result is data you — and inspectors — can trust, across laboratory and manufacturing systems.
What we do
- Data-governance framework design and implementation
- Audit-trail configuration and audit-trail-review programs
- Access-control and segregation-of-duties remediation
- Data life-cycle, backup and retention controls
- System-level ALCOA+ control implementation
- Data-integrity culture and training
Our process
- 1
Assess
Map data flows and ALCOA+ vulnerabilities.
- 2
Design
Define governance, controls and review processes.
- 3
Implement
Configure technical controls and procedures.
- 4
Sustain
Embed review discipline, training and monitoring.
What you receive
- Data-governance framework
- Audit-trail-review and access-control procedures
- Implemented technical controls
- Data-integrity training
Who needs this
Sites digitizing records, organizations remediating data-integrity findings, and teams operationalizing audit-trail review and access control.
Frequently asked questions
Ready to improve your compliance?
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.