Quality and Compliance Statements

Integral Biometrics Compliance Statement with 21 CFR Part 11

Integral Biometrics is committed to ensuring that our electronic records and electronic signatures comply with the stringent requirements set forth by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 11. This regulation outlines the criteria for acceptance by the FDA of electronic records, electronic signatures, and handwritten signatures executed to electronic records as trustworthy, reliable, and generally equivalent to paper records and handwritten signatures on paper.

To achieve and maintain compliance, Integral Biometrics has implemented the following measures:

1. System Validation: We ensure that all computerized systems used to create, modify, maintain, archive, retrieve, or transmit electronic records are validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
   
2.  Audit Trails: Our systems generate secure, computer-generated, time-stamped audit trails that independently record the date and time of operator entries and actions that create, modify, or delete electronic records. These audit trails are maintained for a period at least as long as that required for the subject electronic records and are available for agency review and copying.
   
3. Security Controls: We implement strict access controls to limit system access to authorized individuals. This includes the use of unique user IDs and passwords, biometric authentication methods, and regular access review procedures to ensure that only authorized personnel can access the system.
   
4. Electronic Signatures: Our electronic signature components are designed to be unique to each user and are linked to their respective electronic records to ensure the authenticity and integrity of the signed records. The use of electronic signatures is equivalent to handwritten signatures in terms of legal and regulatory standing.
   
5. Record Retention: Electronic records are maintained in a durable, readily accessible format for the entirety of their required retention period. This ensures that records are preserved and retrievable in an accurate and legible format when needed.
   
6. Training: All personnel involved in the management, operation, and use of electronic records and electronic signatures are provided with comprehensive training to ensure they understand their responsibilities and the importance of compliance with 21 CFR Part 11.
   
7. Documentation: We maintain detailed documentation of our compliance procedures, validation protocols, and audit trail reports, making them available for review by regulatory agencies and auditors as required.
   

Integral Biometrics is dedicated to maintaining the highest standards of data integrity and security, ensuring that our practices comply with all applicable regulatory requirements, including 21 CFR Part 11.

For further information or inquiries about our compliance program, please contact our compliance officer at rallen@integralbiometrics.com.

————————

Integral Biometrics GDPR Compliance Statement

Integral Biometrics is committed to ensuring the privacy and protection of personal data in accordance with the General Data Protection Regulation (GDPR) (EU) 2016/679. We recognize the importance of data protection and have implemented comprehensive measures to comply with GDPR requirements, ensuring the security and confidentiality of personal data processed by our organization.

Data Protection Principles

Integral Biometrics adheres to the key principles outlined in the GDPR, which include:

1. 
   Lawfulness, Fairness, and Transparency: Personal data is processed lawfully, fairly, and in a transparent manner. We inform data subjects about how their data is collected, used, and shared.
   
2. 
   Purpose Limitation: Personal data is collected for specified, explicit, and legitimate purposes and not further processed in a manner that is incompatible with those purposes.
   
3. 
   Data Minimization: We ensure that personal data collected is adequate, relevant, and limited to what is necessary in relation to the purposes for which it is processed.
   
4. 
   Accuracy: Personal data is accurate and, where necessary, kept up to date. We take all reasonable steps to ensure that inaccurate personal data is rectified or erased without delay.
   
5. 
   Storage Limitation: Personal data is kept in a form that permits identification of data subjects for no longer than is necessary for the purposes for which the personal data is processed.
   
6. 
   Integrity and Confidentiality: Personal data is processed in a manner that ensures appropriate security, including protection against unauthorized or unlawful processing, accidental loss, destruction, or damage, using appropriate technical and organizational measures.
   
7. 
   Accountability: Integral Biometrics is responsible for, and can demonstrate, compliance with these principles.
   

Data Subject Rights

Integral Biometrics respects and facilitates the rights of data subjects as provided under the GDPR, which include:

• The right to be informed about the collection and use of their personal data.
• The right of access to their personal data and supplementary information.
• The right to rectification of inaccurate or incomplete personal data.
• The right to erasure (the right to be forgotten) under certain circumstances.
• The right to restrict processing of their personal data.
• The right to data portability, allowing them to obtain and reuse their personal data for their own purposes across different services.
• The right to object to the processing of their personal data under certain conditions.
• The right not to be subject to a decision based solely on automated processing, including profiling.

Security Measures

Integral Biometrics has implemented robust technical and organizational measures to ensure a high level of security appropriate to the risk, including:

• Encryption of personal data where appropriate.
• Regularly updated security protocols and practices.
• Access controls to limit data access to authorized personnel only.
• Regular security assessments and audits.
• Data breach detection, reporting, and response protocols.

Data Protection Officer (DPO)

We have appointed a Data Protection Officer (DPO) who is responsible for overseeing our data protection strategy and implementation to ensure compliance with GDPR requirements. The DPO can be contacted at [contact information].

Data Processing Agreements

Integral Biometrics has established Data Processing Agreements (DPAs) with all third-party processors to ensure that they comply with GDPR standards and provide adequate protection for personal data.

Continuous Improvement

We continuously review and enhance our data protection policies and practices to ensure ongoing compliance with GDPR and to respond to emerging privacy and security threats.

For more information about our GDPR compliance program or to exercise your data protection rights, please contact our Data Protection Officer at [contact information].

Integral Biometrics Data Protection Office

This statement outlines the key aspects of GDPR compliance relevant to Integral Biometrics and can be tailored further based on specific organizational practices and procedures in place.

———————
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate

Integral Biometrics Data Integrity Statement

At Integral Biometrics, we are committed to maintaining the highest standards of data integrity. Ensuring the accuracy, consistency, and reliability of data throughout its lifecycle is essential for our operations and the trust we place in our systems and processes.

Principles of Data Integrity

Our approach to data integrity is based on the following key principles:

1. 
   Accuracy: We ensure that all data entered into our systems is accurate, precise, and reflective of real-world conditions. Regular audits and validation checks are conducted to maintain this standard.
   
2. 
   Consistency: We maintain consistency in data through standardized processes and protocols. Our systems are designed to enforce uniformity in data handling, storage, and retrieval.
   
3. 
   Completeness: All necessary data is captured and retained. We ensure that no critical data is omitted and that data sets are comprehensive and intact.
   
4. 
   Reliability: We guarantee that our data is reliable and trustworthy. This involves implementing robust data governance policies and continuous monitoring to prevent and address discrepancies.
   
5. 
   Transparency: Our processes are transparent, and we maintain clear documentation and audit trails. This transparency ensures that data handling can be tracked and verified at any point in time.
   

Measures to Ensure Data Integrity

To uphold these principles, Integral Biometrics has implemented a comprehensive data integrity program, which includes:

1. 
   Standard Operating Procedures (SOPs): Detailed SOPs govern all aspects of data handling, from collection to processing and storage. These procedures are regularly reviewed and updated to reflect best practices and regulatory requirements.
   
2. 
   Training and Awareness: All personnel are trained in data integrity principles and practices. Ongoing education ensures that our team remains vigilant and knowledgeable about the importance of data integrity.
   
3. 
   Access Controls: We have strict access controls in place to ensure that only authorized personnel can access or modify data. Role-based access ensures that individuals have the appropriate level of access required for their responsibilities.
   
4. 
   Audit Trails: Our systems generate detailed audit trails that record all data-related activities. These audit trails are regularly reviewed to detect and address any anomalies or unauthorized actions.
   
5. 
   Data Validation and Verification: Regular validation and verification processes are conducted to ensure the accuracy and completeness of our data. Any discrepancies are promptly investigated and resolved.
   
6. 
   Change Management: Any changes to data handling processes or systems are managed through a formal change management process. This ensures that changes are thoroughly evaluated, documented, and implemented without compromising data integrity.
   
7. 
   Continuous Monitoring and Improvement: We employ continuous monitoring techniques to detect and prevent data integrity issues. Feedback mechanisms and periodic reviews are used to continually improve our data integrity practices.
   

Commitment to Quality and Compliance

Integral Biometrics is dedicated to upholding the highest standards of quality and compliance. Our data integrity program is aligned with relevant regulatory requirements, industry standards, and best practices. We are committed to continuous improvement and regularly engage in internal and external audits to ensure our practices remain exemplary.

For further information or inquiries about our data integrity program, please contact our quality assurance department at [contact information].

Integral Biometrics Quality Assurance Department

This statement outlines the key aspects of data integrity relevant to Integral Biometrics and can be tailored further based on specific organizational practices and procedures in place.