Last Updated: 6/18/25
Compliance & Quality Assurance Statement
Affine Vision LLC (“we,” “us,” “our”) understands that the pharmaceutical industry operates under the most stringent global regulatory frameworks. Our products and services are engineered from the ground up to support your quality and compliance objectives.
Supported Regulations & Standards
21 CFR Part 11 – Electronic Records & Signatures
Our inspection software is fully aligned with FDA 21 CFR Part 11 requirements for electronic records and signatures. Key features include:
- Audit Trails: Every configuration change, inspection result, and user action is automatically time-stamped and logged.
- Role-Based Access Control: User permissions are strictly defined and enforced to protect data integrity.
- Electronic Signatures: Configurable workflows ensure that approvals, reviews, and releases are executed with secure, compliant e-signatures.
- Data Retention & Security: All records are securely stored with encryption and version control, supporting both internal QA audits and external regulatory inspections.
EU GMP Annex 1 – Sterile Manufacturing
Our high-resolution computer vision inspection systems are engineered to support Annex 1 requirements for contamination control and sterile product integrity:
- Particulate Detection: Automated, validated algorithms detect and classify particulates with sub-micron resolution.
- Defect Identification: Real-time identification of cosmetic and functional defects in containers, closures, and product surfaces.
- Contamination Control: Non-contact inspection reduces risk of product compromise, while automated records provide a complete data trail for CAPA investigations.
- Data Integrity: System design ensures inspection data is contemporaneous, attributable, and tamper-evident.
Good Manufacturing Practice (GMP) Principles
Our inspection solutions are designed to comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available):
- Attributable & Legible: Each record links directly to the operator, batch, and product inspected.
- Contemporaneous: Data capture occurs at the time of inspection, with no manual transcription required.
- Original & Accurate: Images, logs, and reports are stored as original unaltered records, with controlled updates tracked in the audit trail.
- Complete & Consistent: All inspection activities are captured without omission, ensuring batch-to-batch comparability.
- Enduring & Available: Data is securely archived and readily retrievable throughout its lifecycle.
Quality Assurance Framework
Our internal Quality Management System (QMS) ensures reliability, repeatability, and regulatory readiness at every stage of system design, manufacturing, and deployment. Our QA deliverables include:
Training & Support
Operator and administrator training programs are provided, ensuring correct use of systems and ongoing compliance with GMP standards.updating the “Last Updated” date.
Installation Qualification (IQ) / Operational Qualification (OQ)
Comprehensive validation protocols verify that systems are installed and operate in accordance with user and regulatory requirements.
Performance Qualification (PQ) Support
We provide guidance and documentation to support end-user PQ execution under production conditions.
Design & Technical Documentation
Detailed Design Specifications (DDS) and Functional Specifications (FS)
Risk assessments and design reviews to demonstrate regulatory alignment
Version-controlled software development documentation following GAMP 5 guidelines
Calibration & Traceability
All systems are delivered with traceable calibration certificates. Calibration procedures are documented, repeatable, and verifiable, ensuring measurement accuracy throughout the product lifecycle.
Change & Configuration Management
Controlled procedures for hardware and software updates ensure continued compliance with validated state.
8. Contact Us
If you have any questions about this Compliance Statement or quality practices, please contact us at: sales@affinevision.com
