Process safety in documentation
When creating documentation for medical machines and products, technical editors must ensure the highest quality and care. Requirements such as GMP (Good Manufacturing Practice) pertain simultaneously to the production environment and processes, including services and product-supporting information, such as operating and installation manuals and service guides.
Other central requirements for the creation of documentation are:
- Shorter and shorter innovation cycles
- Increasing numbers of product variants
- Many required languages
- Federal and international legal requirements (FDA, GMP, Regulatory Affairs)
- Reviews and audit security (auditing)
- The need to address B2B customers, medical institutions (clinics / doctors' practices), and B2C customers (HomeCare)
The editing and content management solutions from SCHEMA offer a user-friendly work platform for creating, managing, validating and generating complex product information.
Text and images once created and released can be used again, providing a high degree of consistent presentation and significantly reducing time on task. Subsequent translation effort is also greatly reduced.
SCHEMA ST4 offers comprehensive process safety and quality assurance when creating text and content. All transactions and tasks can be verified in the editing system, audited, and exported as a report, ensuring compliance with GMP requirements.
Further optimization can be gained by automating layout creation. Interfaces to common layout products for digital pre-press make it possible to generate high-quality publications.
By using SCHEMA ST4, quality assured multi-lingual documentation is available for delivery at the same time as your product.
Questions?