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FDA Validation Compliance

 

 

FDA Validation Compliance

ADB provides a whole package of validation and compliance services for the FDA regulated industries. Our experience and expertise in FDA validation compliance include current Good Manufacturing Practices (cGMP) for medical devices, pharmaceuticals, food and beverage, active pharmaceutical ingredients, sterile fill and computer software validation.

With your cooperation, we will join hands and offer all your regulatory requirements whether you are a long established company or start up business. Every process and product require validation especially those that process output cannot be verified using measuring or monitoring. Validation is conducted to minimize the cost of production and make sure FDA regulatory requirements are followed to latter.

Our target audience includes:

  • QA/QC managers & analysts
  • Scientists and clinical managers
  • Compliance managers
  • Automation analysts
  • Lab managers
  • Analytical chemists
  • Information technology analysts
  • Good manufacturing Practices training analysts

FDA validation compliance guidance is used by Good Manufacturing specialists and individuals who are responsible for pharmaceutical auditing and computer system validation compliance, execution, reporting and planning. It is used to detect critical bugs and security vulnerabilities to promote best practices in process and product reliability and minimizing validation costs. The world’s leading pharmaceutical device manufacturers have chosen ADB as a standard part of their process and product development and validation procedure.

Our FDA validation compliance exercise addresses the following criteria;

  • Importance of the test method
  • Purpose of the test method
  • Checking if the data was created by use of coded chemicals and Good Laboratory Practice (GLP)
  • Mechanistic starting point of the test procedure

Framework for validation compliance

ADB validation system experience and methodologies are comprehensive and applies to both home-grown and off-the-shelf software. Our validation framework ensures the products and processes are accommodating FDA requirements and for many years they will be still complaint. The main element of the FDA compliance framework include:

Falling in line with 21CFR part II conditions

This ensures the software or the process follows FDA compliance regulation requirements such as:


  • Recording changes in the audit trail and providing information with change reasons and operator name
  • Use of electronic signatures in case of a transaction in the system
  • Security guarantee in case of unauthorized modification

Software Development Lifecycle (SDLC)

This ensures the technology company or expert follows the software guidelines in developing quality and flawless software. The elements of SDLC are:

  • System requirements
  • System design
  • Test plans, procedures and cases
  • Coding standard
  • Multi-level testing procedures such as system test, unit test, integration and functional test
  • Closed-loop modification control

FDA validation compliance is not a onetime practice, but an unending process. ADB will ensure you get a good implementation system validation process and minimal cost of compliance.

 

 

 


Testimonial / What Our Client Say

Andre and his team were professional, focused and sensitive to the timing issues associated with my project. Most importantly, after the project completed Andre and his team did not disappear. As I needed answers and follow up information, his team followed up in a timely and accurate manner. I look forward to using the services again and would recommend them highly.

Erik Emerson, President & CEO at Symplmed



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