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"
  1. Helping implement a risk-based approach to ensure data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) throughout the full data lifecycle

  2. Conducting internal assessments and periodic reviews to ensure compliance is maintained

  3. Framing and implementing a scalable data governance and management model. Read more about our Data Management Services.

  4. Working with management with executive responsibilities to create a culture of quality where Data Integrity is a core value

  5. 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:

  1. Conducting regulatory, risk and impact assessments

  2. Creating validation strategies to align with regulatory requirements, corporate methodologies and business needs

  3. Drafting and maintaining traceability matrices

  4. Designing and documenting test scripts to ensure appropriate levels of evidence and rigor

  5. Executing tests and documenting defects and observations

  6. 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

How We Do It

Assess your organization’s current state of data integrity and devise a go-forward plan through SQA’s subject matter experts.

Leverage our subject matter experts to help execute and implement these plans to achieve data integrity.

Provide local, onsite consultants with industry and regulatory experience to augment your teams and help maintain these important initiatives.

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