QUALITY ASSURANCE (QA)

The objective of Design Catapult Manufacturing’s Quality Assurance (QA) program is to assure that all manufacturing processes, and data collected are precisely, and accurately administered. Specifically, this means that all work is done in compliance with customer requirements along with all applicable FDA, cGMP, and ISO standards, and that all documents generated meet the requirements of those standards.

The following is a summary of the key elements of DCM’s QA program:

• Intensive QA/QC Program that adheres to regulation requirements for GLP/cGMP/ISO compliance.

• Quality Assurance Unit (QAU) that is organizationally and functionally independent from operations.

• Documentation and Tracking Procedures that ensure traceability.

• Procedures that define the authority and responsibility for all individuals.

• Procedures for the Training and Implementation of all QA/QC related activities.

• Extensive Employee Training Program designed to assure consistency and compliance.

• Documentation System that details the requirements for all tests and processes including all record keeping, Batch Records, and validation procedures.

• Review and Release Program for all documentation, data and reports.

• Auditing Program that monitors Compliance with all the applicable regulations and guidelines.

Certifications

To find out more about our quality services, please contact us at (949) 522-6789 or if you want to get started now request your free quote.