Enhancing Data Integrity: A Global Pharmaceutical’s Journey to Operational Excellence and Compliance”

Data Integrity Maturity Model

Pharmaceutical companies operate in a highly regulated environment where data integrity is essential for compliance, operational efficiency, and product safety. A multinational pharmaceutical company recently sought to enhance its Data Integrity Maturity Model, ensuring its laboratory equipment, manufacturing lines, and quality systems adhered to the highest industry standards. With over 30 years of experience in Validation and Data Integrity, Dataworks was selected to partner with them on this critical site project. Our team provided expertise in regulatory compliance, cGAMP guidelines, and industry best practices, helping refine their Data Integrity playbook and implement structured improvements.

The project began with a comprehensive assessment of GxP systems, evaluating their interactions and compliance risks. Through a detailed review of Standard Operating Procedures (SOPs) and Work Instructions, as well as discussions with Subject Matter Experts (SMEs), we developed a thorough understanding of data generation, utilization, and storage processes.
To ensure compliance and security, we conducted Segregation of Duties (SoD) analysis, verifying that personnel had appropriate qualifications, access levels, and responsibilities. Additionally, Audit Trail Reviews were performed to assess system audits’ timing, rationale, and compliance with regulatory requirements.

 

Dataworks Outputs

Following this structured approach, Dataworks delivered high-value outputs, including:

• Data Flow Maps: Providing a clear visualization of data movement and storage.
• Data Flow Risk Assessments: Identifying potential risks and implementing mitigation strategies.
• Segregation of Duties Reports: Defining roles and responsibilities to enhance security and compliance.
• Audit Trail Reviews: Ensuring audit processes align with industry and regulatory expectations.

Insights

These insights were compiled into comprehensive reports, ensuring long-term compliance and efficiency across manufacturing lines and laboratory operations.
The impact was clear: enhanced regulatory compliance, improved data governance, and optimized operational performance. As the Site D.I. Project Lead shared, “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.”

For pharmaceutical companies looking to strengthen their Data Integrity Maturity, partnering with a trusted expert like Dataworks can make all the difference. Get in touch with us today to see how we can support your compliance and efficiency goals. Please contact us on 051 878555 or email info@dataworks.ie

To stay up to date with Dataworks Limited news and events, connect with us via the links below: