Data Integrity Services
Can your data be trusted?
Even if you’re “checking all the boxes” in the regulatory world, you need to prove your data is thorough and legitimate. No secret there. So, what are you doing to ensure it is? How can you maintain legitimacy more efficiently? Let’s chat.
Data Integrity Frameworks
The regulatory bodies, like FDA, have been focused on product, process and patient safety. To accommodate, emphasis has appropriately been put on integrity of the data utilized to prove safety.
SQA helps organizations subject to these regulations across all stages of the data lifecycle: generation > processing > review/reporting > use > retain/retrieve > destruction
Our capabilities include:Based on FDA’s guidance on Data Integrity and Compliance (December 2018), the term Data Integrity "refers to the completeness, consistency, and accuracy of data"
Helping implement a risk-based approach to ensure data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) throughout the full data lifecycle
Conducting internal assessments and periodic reviews to ensure compliance is maintained
Framing and implementing a scalable data governance and management model. Read more about our Data Management Services.
Working with management with executive responsibilities to create a culture of quality where Data Integrity is a core value
Conducting personnel training to build this culture within teams
Computer Systems Validation Services
Ensuring and maintaining Data Integrity requires technology. Organizations that are implementing regulated computerized systems need to ensure they are suitable for use and compliant with legislation and internal policies.
Our Computer Systems Validation team brings a thorough knowledge of global regulatory requirements and technology expertise to ensure an audit-ready validation package for implementation of regulated systems.
Our capabilities include:
Conducting regulatory, risk and impact assessments
Creating validation strategies to align with regulatory requirements, corporate methodologies and business needs
Drafting and maintaining traceability matrices
Designing and documenting test scripts to ensure appropriate levels of evidence and rigor
Executing tests and documenting defects and observations
Coordinating acceptance testing and documenting validation summary reports
"Thank you again for all that your organization did to support the badly needed changes in testing, agile and process improvements. You and your team did make a difference."- Dan Sheehan, Chief Information Officer, Beacon Health Options