Quality System and Regulatory Support
Communication, documentation, and training are essential to effective quality systems and to meeting regulatory requirements. We help you get maximum benefits from your efforts.
We start by analyzing your organization’s current systems. We’ll recommend process improvements and develop documentation and training for the new processes and systems. And, we’ll help you identify the risks in your system, determine necessary controls, and be sure that your processes satisfy compliance regulations. These are some of the areas in which we provide support for quality and regulatory systems.
- Six Sigma: Just-in-time Six Sigma, including customized Six Sigma training and coaching, new process development and training, and knowledge transfer.
- ISO 9000: 2000/QS9000: Certification readiness including gap analysis; process improvement facilitation; support for quality manual, procedures, and work instruction development; document control; and internal auditing.
- Capability Maturity Model (CMM): Helping organizations move through the maturation process by providing process mapping and process improvement support, documentation of newly systematized processes, and change management and communication.
- Regulatory Audits: Developing validation documentation for FDA compliance requirements including process requirements and process descriptions, and facilitating risk identification and process documentation for industry-regulated audits.
