Data Integrity in Pharmaceuticals: Strengthening Compliance and Maturity Models
The importance of strengthening Data Integrity Maturity Models
In today’s pharmaceutical landscape, data integrity is more than a compliance requirement—it’s a cornerstone of operational excellence and patient safety. Having worked extensively with global pharma leaders, our team has seen first-hand how a structured approach to data governance transforms efficiency and compliance outcomes.
This post revisits one of our recent projects, reshared here with updated context and learnings, to highlight the importance of strengthening Data Integrity Maturity Models across laboratories and manufacturing environments.
Project Overview
A leading multinational pharmaceutical company partnered with Dataworks to enhance its site-wide Data Integrity Maturity Model. With more than 30 years of experience in Validation and Data Integrity, our team provided expertise spanning regulatory compliance, cGAMP guidelines, and best practice implementation.
The engagement began with a full assessment of GxP systems, including Standard Operating Procedures (SOPs), Work Instructions, and interviews with Subject Matter Experts (SMEs). This approach ensured a deep understanding of how data is generated, managed, and stored across the site.
Key Steps Taken
To strengthen compliance and reduce risk, the project included:
- Data Flow Mapping – visualizing how data moves across laboratory and manufacturing systems.
- Risk Assessments – identifying vulnerabilities in data flows and implementing mitigation measures.
- Segregation of Duties (SoD) Reviews – confirming that roles, access levels, and responsibilities aligned with compliance requirements.
- Audit Trail Analysis – evaluating audit processes to ensure adherence to regulatory expectations.
These structured outputs gave the client actionable insights and practical tools for ongoing governance.
Outcomes Achieved
By applying a rigorous approach to pharmaceutical data integrity compliance and best practices, the project delivered:
- Enhanced regulatory alignment
- Stronger data governance
- Optimized operational performance
The Site D.I. Project Lead commented:
“Thank you for your support over the last year (again) – your team have produced a high-quality output as always. I would highly recommend you for any future projects.”
Why Data Integrity Matters More Than Ever
For pharmaceutical companies, investing in data integrity is not just about meeting today’s compliance expectations—it’s about building resilience for the future. Strengthening maturity models ensures better decision-making, smoother regulatory audits, and reduced operational risk.
Partner with Dataworks
If your organization is looking to advance its Data Integrity Maturity Model or implement pharmaceutical data integrity compliance best practices, our team is here to help.
📩 Get in touch today to learn how we can support your compliance and efficiency goals.
Contact us
📞 051 878 555
📧 info@dataworks.ie
🌐 www.dataworks.ie
