Governance, Lifecycle, and Management Expertise
Data integrity (DI) refers to the degree to which data is complete, consistent, accurate, trustworthy, and reliable, as well as maintained throughout the data life cycle. This is essential for proving the safety, efficacy, and quality of GxP regulated products. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. Implementing data lifecycle controls and validating computerized systems are necessary measures to ensure you are ready for inspections at any moment. Successfully demonstrating your compliance with current regulations, best practices, and company policies is critical.
Our team of DI experts can help you develop and implement a robust data integrity framework to maintain control of the full life cycle of data. Depending on your needs, ProPharma Group offers a range of DI services that allow you to remain focused on your core business, including:
- Staff augmentation to complete project outsourcing
- Situation assessment to resolution development
- Specific technical solutions to full DI governance program
Ineffective Data Control
Ineffective data control throughout the data lifecycle can create regulatory and compliance issues, putting outcomes at risk.
Improved Data Control
With our knowledgeable team of DI experts and successfully proven programs and solutions, we provide world-wide audits and/or gap assessments to quantify your strengths and identify areas of improvement.
Data Integrity Service Offerings
Our data integrity experts partner with you to establish an effective data governance program. The ProPharma Group Data Integrity services include, but are not limited to:
- Creating awareness by training employees and senior management
- Implementing plans for strategic data integrity that improve leadership and data ownership
- Implementing data integrity policy
- Providing data integrity risk assessments and prioritization
- Providing process and data mappings
- Providing data integrity SOPs using the principles of ALCOA+
- Providing audits and implementing self-audit programs
- Providing guidance on how to expand DI cultural adoption
- Reporting on data lifecycle maturity factor characterization and effectiveness
- Performing mock FDA/international regulatory agency inspections