Staying compliant with FDA and EMA regulations is challenging, even for the most experienced organizations. A fully qualified infrastructure is required for validated systems that must comply with FDA or EMA regulations.
Leveraging our extensive experience documenting and implementing strong change controls, we can qualify networks, servers, and platforms. We can also qualify the tools needed to manage and support these components and keep them compliant.
We have extensive experience qualifying systems such as:
- Networks – firewalls, switches, routers, and load balancers
- Servers/workstations – Microsoft Windows, Linux (CentOS, Ubuntu, etc)
- Platforms – VMware, Hyper-V, Microsoft SQL Server, Oracle, MySQL, Postgress and more
We support this qualification effort with the appropriate SOPs and policies to keep the qualified systems in control and compliant once operational. The requirements have subtle differences depending on the overseeing regulatory requirements and risk profile.
We also offer consulting and engagement services, including but not limited to the following, to help draft quality documents:
- Change control and risk management
- Design documentation and requirements (FRS, SDS)
- Training, document development, and good documentation practices