In highly regulated industries, compliance with a large number of norms, standards and legal requirements is not just an obligation, but crucial for the long-term success and marketability of your products. However, managing these requirements – from monitoring new regulations to providing seamless evidence – is time-consuming and ties up valuable resources. Every manual update and every search for evidence for audits delays progress.
BAYOOSOFT Themis integrates the requirements of the most important regulations directly into your single source of truth, enables process-guided document creation and ensures that your information is always networked and traceable. This allows you to turn time-consuming compliance tasks into a strategic advantage. Master approvals and audits with system and confidence to bring your products to market faster and more securely.
BAYOOSOFT Themis and the relevant regulations, norms & standards
BAYOOSOFT Themis covers all relevant standards and regulations in medical technology – from MDR and IVDR to international standards and country-specific market approvals. Thanks to the modular structure, you can use exactly the packages you need for your compliance.
The overview shows you which Themis modules apply to which standards and how you can set up your documentation efficiently and audit-proof.
Validation of BAYOOSOFT Themis: Your added security
The validation of computerized systems is a central component of regulated environments – especially in the context of medical devices and quality management systems. The aim is to provide traceable proof that requirements are implemented correctly and that software can be used reliably in the intended area of application.
In practice, this means that requirements must be clearly defined, implemented in a structured manner and documented in a verifiable manner. This is exactly where BAYOOSOFT Themis comes in.
The V-model clarifies the underlying validation logic: requirements at different levels are systematically specified and validated through suitable inspection and test steps. This structure forms the basis for transparency, traceability and audit security in regulated processes.
Comprehensively validated and standard-compliant
BAYOOSOFT Themis is a validated software solution developed for use in regulated environments. The software meets the relevant requirements for computerized systems and supports companies in implementing regulatory requirements such as ISO 13485, MDR or ISO 27001 in a structured and efficient manner.
Themis digitizes and centralizes documentation and management processes. This reduces manual activities, keeps information consistent and documents changes in a traceable manner – a stable basis for daily operations as well as for audits.
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