A joint project has developed into a strategic partnership. Digital Life Sciences and Diapharm GmbH & Co. KG will join forces to offer their expertise to companies in the life sciences industry. It all began with an in-house collaboration: We supported Diapharm in digitising their quality management system.
This project demonstrated how closely regulatory expertise, process understanding, and digital implementation are interlinked. If a quality management system is digitised without first reviewing its underlying structure, existing processes may simply be transferred to the digital environment unchanged. Clear responsibilities, coordinated processes, and a sound regulatory framework are therefore crucial to the project’s success.
Regulatory consulting and digital implementation from a single source
For nearly 40 years, Diapharm has been helping companies establish, optimise, and operate quality management systems. Their services range from developing robust QMS structures that meet regulatory requirements, to preparing for regulatory inspections and obtaining permits, to filling legally defined roles such as Qualified Person, QP for pharmacovigilance, or Responsible Person for Wholesale.
DLS contributes the engamp® | software suite: our modular eQMS platform, which was developed specifically to comply with applicable regulations and guidelines such as FDA 21 CFR Part 11, the EU GMP Guidelines, and ISO 13485.
The joint approach at three levels
- Strategic QMS development: Gap analysis of existing systems, development of customised QMS structures, creation of SOPs, and regulatory consulting by Diapharm.
- Digital implementation: Mapping the agreed processes in engamp®, configuration, validation, and integration into existing IT landscapes by Digital Life Sciences.
- Continuous development: Monitoring, regular system reviews, and adaptation to new regulatory requirements.
Our services are aimed at companies at various stages of development. Startups and scale-ups can build their quality management systems digitally from the very beginning; established companies can modernise their existing hybrid structures; and multi-site organisations gain a unified foundation for cross-location collaboration. Companies that are facing regulatory inspections or need to apply for permits can also benefit from a structured approach through this partnership.
We would like to thank Diapharm for the trust they have placed in us and look forward to working together to support companies in implementing a structured, regulatory-compliant, and practical quality management system.
For more information on this collaborative approach, please see the blog post on the Diapharm website:
