Is your Quality and Compliance Department effective? How do you know? If FDA showed up tomorrow, would a positive inspection outcome be certain? Have you developed a Quality Strategic Plan? Are your issues and gaps collected, analyzed and prioritized for remediation? Does your team have the right skills – quality engineering, CAPA, writing, leadership, program management, measurements, etc., etc. – to protect your organization in today’s enforcement climate? Is your quality organization innovative? Do they understand risk? Are they helpful to the organization?
If you aren’t 100% sure of the answers to the foregoing ... we should talk.
Compliance Architects® regularly works with Quality and Compliance Departments that need support. A key area that most companies need help with is quality planning. We have developed a breakthrough planning approach and tool, our CRPN Quality Roadmap™ Methodology & Cloud Application. The CRPN Quality Roadmap™ is a consulting service offering comprised of a defined, structured methodology, proprietary risk and complexity algorithms, and cloud-based software tool that together facilitates intelligent, semi-quantitative, risk-based planning for regulated, life-science manufacturers. Offered EXCLUSIVELY by Compliance Architects®, this highly-innovative approach to quality issue and activity management is reducing risk, and helping executives to justify and substantiate resource needs with executive stakeholders.
SO LET US HELP!
We work with your internal quality, operations, compliance and regulatory teams, providing the targeted skills, capabilities and outcomes that can move an organization from good to great. It’s virtually impossible to have all the requisite knowledge, skills, and experience within EACH of your company’s Quality and Compliance departments to meet today’s regulatory requirements and expectations. We mentor, train, and help structure roles and operations for maximum effectiveness. We can also provide managed services for those areas where it just doesn’t make sense investing in internal personnel.