

For SMEs in the medical device sector, ERP compliance is mandatory. Learn how to implement the regulations.

Learn how ERP systems meet GxP requirements with audit trails, documentation, and built-in compliance.

Learn how a validated ERP system helps biotech companies meet GMP, ISO 13485, and FDA requirements.

Learn how to validate your ERP system in line with GAMP5 and discover insights tailored to regulated industries.

Find out how you can regulate audit trails & electronic signatures and comply with FDA 21 CFR Part 11.

GMP brings together all measures that ensure consistently high quality in the production of medical products.

A quality audit is a systematic and documented assessment procedure from quality management.

GAMP 5 is the guideline for ensuring the quality and compliance of automated systems in the pharmaceutical industry.

An audit trail electronically documents the correct execution of processes and strict compliance with all defined steps.

We explain what Good Distribution Practice is, which requirements it sets, who is affected, and how certification works.

Software validation checks that software meets the requirements and is suitable for the intended purpose.

GxP stands for “Good Practices” – a set of guidelines to ensure quality and compliance in the life sciences.

Process validation provides documented proof that a process delivers predefined results and poses no risk.

Supplier evaluation is a process that enables companies to assess suppliers based on defined criteria.

Computer system validation is a documented process that ensures software does exactly what it was designed for.

This article shows you how to navigate the challenges and pitfalls of computer system validation with confidence.