About Stelex

About our Services:

Stelex is a consulting firm providing enterprise-wide compliance solutions for over 20 years. The firm delivers a comprehensive suite of Business, Regulatory, Technology, and Validation solutions.

Stelex’s corporate office is located in Bensalem, PA, with regional offices in Puerto Rico, Illinois and New Jersey. These offices are the direct result of years of doing business, in the Caribbean, New England, the Midwest and Northeast, and enable the firm to provide local support to the growing global needs of its clients.

For over 20 years, Stelex has built its reputation on the long-term relationships established with both its clients and partners. Stelex is positioned to be your total compliance solutions provider.

Business Solutions:

  • Program Management
  • Process Management
  • Best Practice Consulting
  • Stelex University

Regulatory Solutions:

  • Quality Assurance & Auditing
  • Pre-Approval Inspections
  • GxP/QSR
  • Quality Systems

Technology Solutions:

  • Software Development
  • Integration / Implementation
  • Security & PKI
  • IT/Application Support

Validation Solutions:

  • Computer / Lab systems
  • Process / Equipment
  • Infrastructure
  • Automation and Controls

What are compliance and validation services?

We analyze, verify, document and remedy those areas of the research and manufacturing process, which are regulated by the FDA.

Typical equipment qualification includes validating the cleaning processes, verifying the operating efficiency, accuracy and testing samples to check quality. Computer systems are validated to ensure each action and alteration to the operating system is time-dated and tracked to a specific authorized individual, in compliance with 21 CFR §11, the FDA’s Rule on Electronic Records/Electronic Signatures.

Stelex is a subsidiary of Vital Signs, Inc. (NASDAQ: VITL) Vital Signs provides products and services to the hospital market and FDA regulated industries. The Company was recently recognized in the October issue of Forbes Magazine as one of “The 200 Best Small Companies”. Vital Signs is ISO 9001 certified and has CE Mark approval for its products.