Standards and Regulations

To put it simply, "compliance" means on the one hand the fulfilment of self-imposed standards and specifications and on the other hand the observance of laws and official requirements. Any self-imposed requirements often go far beyond the legally binding framework.

A compliance violation can take on existential proportions. Recall actions - for example - have also reached gigantic proportions in the meantime. Liability is no longer limited to the company or management, but also extends to extended management, executives and even employees.

For the fulfillment of norm defaults and achievement of an associated certification as well as for the adherence to the valid legal situation enterprises lead therefore a complex documentation and administrative apparatus. For effective implementation, traceability and verification, countless guidelines, instructions, processes, reports etc. are created, checked, released, distributed, trained and kept up to date. The expenditure moves often in extremely cost-intensive dimensions, due to the rising Regularien-Anzahl as well as - complexity with rising tendency.

Ensuring compliance conformity (according to the applicable versions) makes a seamlessly monitored management system indispensable for many companies today.
DHC VISION provides a wide variety of products and functionalities for the documentation and control of the entire specification documentation as well as for the administration of standards, audits or non-conformities, in order to achieve compliance conformity with significantly reduced effort, with complete process reliability and traceability at the same time. The solutions are simple and intuitive to use: Simple and Smart.

By using DHC VISION software, companies can ensure compliance with the following regulations and standards:

• DIN EN ISO 9001:2015
• DIN EN ISO 13485:2016
• DIN EN ISO 14971:2013
• DIN EN ISO 14001:2015
• OHSAS 18001:2007
• DIN EN ISO/IEC 27001:2017
• 21 CFR Part 11
• 21 CFR Part 820
• DIN EN ISO 9100:2018
• IATF 16949:2016
• GxP
• Annex 11 to the EU GMP Guidelines
• a.m.

For the highly regulated environment (GxP, FDA) such as the pharmaceutical industry, biotechnology, chemicals or medical technology, DHC VISION offers solutions that are perfectly tailored to the processes of these industries. They can be implemented and operated in various implementation scenarios.