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. Did you know that, regardless of company size, roughly 50% of all global drug 483s letters that have been issued over the last 7 years cite data integrity concerns?
Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. Implementing data lifecycle controls, validating computerized systems and a data integrity oriented culture are necessary measures proving the quality of your products. This ensures you are ready for inspections at any moment.
Our team of DI experts can help you develop and implement a robust data integrity framework to maintain control of your data life cycle. Depending on your needs, ProPharma Group offers a range of DI services that allow you to remain focused on your core business, including:
- Situation assessment to resolution development including a DI strategy
- Set up DI Implementation Plan Specific technical solutions to support your DI governance strategy
Ineffective Data Control
Ineffective data control throughout the data lifecycle can create regulatory and compliance issues, leading to incorrect decision making. If you implement a sound DI governance, set the right technical controls and guide your people towards the right attitude, you are able to demonstrate the regulatory agencies you are in control of your data.
Effective Data Control
Successfully demonstrating your effective data control with current regulations, best practices, and company policies is critical. With our knowledgeable team of DI experts and successfully proven programs and solutions, we provide a full range DI services to a next level of being in control of your data. We are happy to assess your starting point and to 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
- Data Integrity maturity scan to measure the level of compliance regarding DI
- 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