Quality assurance at NOTOCORD®

The Quality Commitment

 

Identified resources

Skills matrices for NOTOCORD® employees are used to map areas and levels of expertise in the company. People's polyvalence and know-how are ensuring continuity in the product development process.

NOTOCORD® employees are trained on the software NOTOCORD-hem™ Evolution and on the quality concepts linked with the GLP / 21CFR Part11 and 58 requirements. Quiz evaluations are conducted and recorded after each training.

Documented method

The following processes are executed within NOTOCORD®'s quality framework in order to pursue our commitment for continuous improvement:

  • Tests processing, software defect detection and correction,
  • Traceability of source code modifications,
  • Analysis and improvement of our processes, products and services
  • Customer quotes and orders review,
  • Process definition and management,
  • Integration and follow up of FDA standards, as well as the regulatory requirements (21 CFR part 58 "Good Laboratory Practices" and 21 CFR Part 11 "Electronic data security "...)

Efficient tools and actions

A number of actions have been implemented and appropriate tools adopted, for both in-house and external activities.

In-house

  • Selection of tools for development, test and source code management, based on their performance and management capabilities,
  • Source code management: Protection of internal and external source code and regular filing to a registered office,
  • Reference documentation for each new product,
  • Preventive actions undertaken to avoid dysfunction or software defects,
  • Risk analysis and prevention related to our information system

For the customers

  • User training,
  • Customized assistance for installation qualification,
  • Support requests management,
  • Claim management (software defect registration, identification and treatment),
  • Corrective action and code corrections management,
  • Customer satisfaction survey

Keywords

  • ISO 9001
  • Audited yearly
  • Continuous improvement
  • Skill matrices
  • Process review
  • Source code management