Systems Development
We define, create, implement and validate custom software systems for the regulated industries. Support and modifications for existing systems are also provided.
Integration and Implementation
We install and customize off-the-shelf software solutions in the Laboratory, Manufacturing, Clinical, Quality and Enterprise arenas for the regulated industries. We integrate these systems into a cohesive business infrastructure to leverage business assets.
Security and PKI (Public Key Infrastructure) Services
Stelex, in conjunction with our partners, offers comprehensive security and PKI solutions for the regulated industries. We assess, define and implement corporate security and PKI infrastructures, security policies, and organizational procedures. In addition, we develop and implement bottom-line-focused security strategies with regulatory and business constraints in mind. Our PKI solutions enhance existing systems, provide value added business services, aid in robust e-signature implementations, and facilitate direct exchange of critical messages with FDA examiners during the NDA (New Drug Application) process.
ComplianceBuilder
Our compliance infrastructure solution is a cost effective, risk based solution that provides out-of-the-box 21 CFR Part 11 compliance capabiilities, while leveraging existing investments. ComplianceBuilder serves as an add-on solution that provides compliance for any Process Control, File or Database system, offering numerous technologic and economic advantages. In comparison with other Part 11 solutions, which require upgrades or enhancements to existing systems, ComplianceBuilder provides a much shorter remediation cycle with minimal production impact during implementation.