Data integrity in regulated industries is more than ALCOA+ … it’s about establishing a data governance program.
Maintaining data integrity in a regulated environment used to be as simple as following ALCOA+. However, it is no longer something that an acronym alone can achieve. Clients are collecting larger volumes of data as they introduce novel products and requiring more from their sensitive data, such as automation, analytics, and decision making. These demands, coupled with increasing expectations and enforcement from regulatory agencies, create the need for a data governance program.
Solutions
We combine decades of industry experience in quality and compliance with numerous data integrity, strategy, and change management projects to deliver a comprehensive data governance program geared for regulated industries that will deliver with true value and sustainability.
Data Integrity Strategy
Achieving data integrity maturity relies on a pragmatic strategy that includes your business goals, known risks, culture, and continuous improvement model.
- Data Integrity Maturity Assessment
- Quality Culture Assessment
- Data Governance Strategy & Policy
Data Integrity Management
The integrity of your data relies on the application of risk management best practices and enablers, allowing you to put appropriate controls in place throughout your operations.
- Data Integrity Assessment
- Audit Trail Review Assessment
- Process Flow / Data Flow Risk Mapping
- Quality Risk Management
- Computerized Software Assurance / Validation / Qualification
- Spreadsheet Validation
- Organizational Change Management
- Self-Inspection and Supplier Inspection
- Training
- Records Management
Data Integrity Technologies
Establishing technologies that prioritize data integrity will ensure long term success.
- Enterprise Architecture Strategy
- Automation and Operations Technology Strategy
- Systems Integration
- Security and Permissions Assessment
- Systems Remediation
What Our Clients Say
Associate Director, Quality Systems
I found Clarkston’s data integrity consultants to be engaged and invested in driving the project. They are hands on and dedicated through the very end.
We have helped global life sciences companies establish scalable data integrity programs that ensure compliance across multiple regulatory bodies and drive demonstrative improvements to operational efficiencies. For more information on how we can help your company, please contact our data integrity consulting expert, LaToya Lee Jones.
