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. Data integrity can be established and managed through the implementation of a framework consisting of rules, processes, and standards. The ultimate goal of data integrity is to ensure an organization’s data remains complete and accurate regardless of the way it’s accessed or how long it’s been stored.
Why is Data Integrity Important?
Data integrity 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 483 letters that have been issued over the last 7 years cite data integrity concerns?
Without proper data integrity processes in place, information can be lost or misinterpreted. Furthermore, implementing a data integrity framework ensures data can be traced back to it’s original source to verify accuracy or the source of errors.
ProPharma Group has a range of data integrity services to help you establish and manage data for your products. Learn about the data integrity best practices we utilize and how we can help you achieve effective data control.
Data Integrity Best Practices
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 data integrity 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 data integrity 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 data integrity 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 data integrity 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
Get Expert Guidance to Ensure Data Integrity Compliance
Maintaining data integrity is important for organizations to ensure the safety, efficacy, and quality of their products. If you’re unsure where to start when it comes to creating and implementing data integrity best practices, ProPharma Group can help. Contact us to learn more about our data integrity services and how we can help your organization achieve effective data control.