Cloud ready for today’s Regulated environments
- 21 CFR Part 11 & Part 820
- Annex 11
- GAMP 5
- SOC 2, Type II
For over a decade, Outer Edge has specialized in designing, managing and assisting its clients to validate cloud-based Quality systems in regulated industries. We partner with our customers to implement strategies to reduce capital expenditures and drive operational efficiencies all while complying with applicable regulatory requirements. Additionally, we routinely assist our Life Sciences customers to satisfy their compliance requirements by providing the documentation and audit trail necessary for their IQ & OQ validation process.
Here are a few of the current Life Sciences instances within our Life Sciences portfolio.
- Laboratory Information System (LIMS)
- Stability Systems (SLIM)
- Manufacturing Execution Systems (MES)
- Plant Maintenance/Calibration Management Systems (CMS)
- Building Automation Systems (BAS)
- Statistical Analytics Software (SAS)
- Enterprise Resource Planning (ERP)
- Clinical Trial Systems
- Environmental Control Systems
We leverage the AWS and Microsoft Azure platforms as well as our own Private Cloud data centers to provide our customers with flexibility.