VisionVault: FDA 21 Part 11 Compliant Databases

FDA CFR (Code of Federal Regulations) 21 Part 11 sets the standard for trustworthiness and reliability concerning electronic records, electronic signatures, and handwritten signatures appended to the electronic records in the pharmaceutical, food, and cosmetic industries.

Integrated with Cognex Insight platforms, VisionVault streamlines FDA CFR 21 Part 11 compliance procedures while providing manufacturers with the ability to control and manage their product inspection systems in real time.

Section 11.10 Controls for Closed Systems

As defined by the FDA a “closed system” means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

Section 11.10 describes the FDA requirements concerning authenticity and database security including:

  • Validation to ensure accuracy and the ability to discern invalid or altered records.
  • Generate accurate, complete copies suitable for inspection and review.
  • Limiting system access to authorized individuals only.
  • Time-stamped audit trails

VisionVault enhances the Cognex Insight platform. When integrated with VisionView 900 VisionVault is the solution for ensuring efficient data archiving and user traceability which comply with all of the above FDA requirements.

Minimize Security Risks with VisionVault

Cognex Insight systems today rely on independent usernames and passwords for each deployed camera. Multiple devices throughout the production line must be set up and managed individually. The odds of lost passwords rise proportionally with the number of devices deployed, creating a vulnerability to unintentional access restrictions and even production shutdowns. There is also a potential for increased administrative and maintenance costs when multiple cameras are used in the inspection process.

VisionVault centralizes all usernames and passwords to Microsoft ActiveDirectory for Administration. Users can then enter usernames and passwords to authenticate with traditional methods or with existing RFID badge scanners at each VisionVault A-D access point. Controlling the levels of user access in this manner is the solution for blocking access to unqualified users who lack the proper system training.

VisionVault Features

As the solution for quality standard enforcement VisionVault offers:

  • Preconfigured and customizable SQL reports
  • Microsoft.NET compliant – SQL 2012
  • MS Windows 7 (32 & 64 bit) and MS Server 2008 R2 (for server only) supported operating systems
  • Microsoft Internet Explorer (+v8.0), Google Chrome (+v17), and Firefox supported browsers
  • Cognex In-sight Explorer 4.9.3+
  • Smooth integration with existing Cognex Vision View 900

Machine Vision Solutions for Pharmaceutical Manufacturing

Stringent FDA requirements and compliance places pharma and medical among the most demanding applications in manufacturing. Quality requirements for these most regulated industries in the world demand nothing less than 100%. Product traceability throughout the supply chain, verifying codes and package integrity requires reliable machine vision systems to ensure these highest of manufacturing standards are met.

Integro Technologies has over 550 cumulative years of machine vision experience with the knowledge and expertise to guide you to the most productive applications for all aspects of pharmaceutical manufacturing. Nearly every segment of the process requires machine vision inspection to test colored pills, detect defects in syringes, check data matrix codes, and ensure accurate labeling, to meet rising volume demands.

VisionVault is the centralized solution for FDA compliance and user traceability, just one of many machine vision solutions offered by Integro for pharma and medical manufacturers.

  • Bullseye Tube and Lumen Inspection- Inspect clear, colored, and opaque tubing in multiple product configurations
  • Anaconda Tube Vision Inspection- Inspect continuous material products such as surgical tubing, cable, and wire at production speeds in excess of 600 feet per minute.
  • Medical Bag Inspection and Verification High precision inspection for colostomy bags in web form within final stations of the assembly process.

Integro is an  Advanced Imaging Association (AIA) Certified Integrator, one of just ten recognized around the world. We are partnered with industry leaders Keyence, Universal Robotics, SICK, MVtec, KUKA Robotics, MORITEX, and Yamaha Robotics. Over 1,000 clients worldwide rely on Integro technologies to maximize production in today’s highly competitive markets. If you’d like to put Integro Technologies’ machine vision resources to work for your company, don’t hesitate to contact us.