Skip to content

Our Quality Policy

Intellitech covers the spectrum to support customers from R&D to GMP for single-use systems.

Our Committment

Intellitech is committed to satisfying customers through the on-time delivery of products that meet requirements while continuously improving the effectiveness of our Quality Management System (QMS). Intellitech’s quality policy is broken down into four, high-level objectives to ensure we meet these commitments:
  • Customer Fulfillment / Product Quality
  • Effectiveness of Our QMS
  • Continuous QMS Improvements
  • Continuous Process Improvements
Intellitech maintains an ISO9001:2015-certified QMS as well as thorough process control and documentation to adhere to GMP guidelines. Intellitech also maintains an ISO7-certified cleanroom manufacturing area, which is qualified by a third-party testing firm.
See Our ISO9001:2015 Certification

Documentation

Intellitech creates, approves, releases, and maintains the required documentation to meet GMP requirements.

As a qualified supplier to top pharmaceutical manufacturers, Intellitech creates, approves, releases, and maintains the appropriate documentation to meet Good Manufacturing Practice (GMP) requirements. This includes drawings, Bill of Materials, work instructions, data collection forms, batch records, and Certificates of Conformance. Intellitech’s document control system employs a validated electronic workflow that meets the requirements of 21 CFR 820.

We welcome the opportunity to work with you

We support companies spanning the realm of R&D to GMP
with a range of products and services.

Call 1-727-914-7000 or contact us to share your project, goals, and challenges.
Contact Us

Product Quality

Product quality is one of Intellitech’s top priorities. Ensuring high product quality requires control over key areas of the manufacturing process. Our experienced Quality Department performs inspections in key areas, ensuring all products that we produce are of the highest quality and that they meet the requirements of our customers. This includes inspections on:
  • Incoming Material
  • Assemblies
  • Packaged Products
  • Packaged Products After Sterilization
Intellitech also identifies and qualifies suppliers of component parts. We continually monitor our suppliers to meet requirements for on-time delivery and rejected material. These are critical aspects of GMP.

Process Control

In nearly every process that Intellitech performs, we have procedures and methods of documentation in place to capture data and ensure high product quality. Examples of where process control is exerted:

  • Non-Conforming Outputs, Deviations, and Incidents
  • Manufacturing Processes, Documents, and Design Changes
  • Process Monitoring and Measuring Equipment

Issues can always occur, despite controls. Intellitech ensures that quality issues are identified and resolved prior to shipment to the customer. If, however, a customer identifies a nonconforming product, Intellitech works closely with the customer to capture feedback, returns, and determine the best corrective action to resolve any issue.

Trained Operators

Intellitech’s Cleanroom Technicians are thoroughly trained on Intellitech’s Single-Use manufacturing processes. They are also subject to occasional competency checks, ensuring all technicians are consistently receiving up-to-date training to maintain high product quality.

Process Control

In nearly every process that Intellitech preforms, we have procedures and methods of documentation in place to capture data and ensure high product quality. Examples of where process control is exerted:

  • Non-Conforming Outputs, Deviations, and Incidents
  • Manufacturing Processes, Documents, and Design Changes
  • Process Monitoring and Measuring Equipment

Issues can always occur, despite controls. Intellitech ensures that quality issues are identified and resolved prior to shipment to the customer. If, however, a customer identifies a nonconforming product, Intellitech works closely with the customer to capture feedback, returns, and determine the best corrective action to resolve any issue.

Trained Operators

Intellitech’s Cleanroom Operators are throughly trained on Intellitech’s Single-Use manufacturing processes. They are also subject to occasional competency checks, ensuring all operators are consistently receiving up-to-date training to maintain high product quality.