Improve Product Quality & Patient Safety
with Qualification as a Risk Mitigating Tool
An IRBCQ approach accelerates project execution and the commercialization of new products, bringing life-saving therapies faster to market. VEQTOR assists manufacturers to evolve and adopt a compliant risk-based approach to C&Q, while promoting top-down organizational acceptance of risk-based methods. VEQTOR assists in laying the foundation for repeatable success and far-reaching efficiencies with Qualification as a risk mitigation tool.
At VEQTOR we do things differently.
First, we build the internal organizational foundation for a smooth transition to risk-based validation from traditional methods. Accountability and technical
agility across all unit operations are incorporated from early planning stages through every development phase of your project.
We assist in creating cross functional teams, communication structures, and change management methodologies to enhance flexibility during execution.
Risk-based C&Q has the added benefit of rapid change while still meeting the C&Q objectives to verify installation and functionality against the user
requirements.
Next, we establish effective and proactive methodology. VEQTOR continuously evaluates risks and mitigation strategies into the C&Q as new process
knowledge is available throughout the lifecycle. Utilizing product and process knowledge with the ability to deploy qualification as a risk mitigation tool,
VEQTOR works with stakeholders to define failure modes and mitigations that become developed elements and are verified in the C&Q.
VEQTOR’s strategy increases value by transforming the company culture to focus on promoting innovation and continuous improvement through
integrating all functional groups, applying an agile and robust change management process, and combining testing into a single verification phase.
Then we implement effective project management. Integrated risk-based C&Q allows for a very aggressive overlapping startup schedule. Our experienced
C&Q Project Managers work collaboratively to develop a resource loading matrix to alleviate bottlenecks and maximize retention of key processes and
product knowledge.
Partnering with project management, VEQTOR establishes core system teams with dedicated Technical and C&Q documentation leads who work in
tandem during development and installation as well as startup, shakedown, commissioning, and qualification activities.
Lastly, we utilize robust engineering change management process. A liaison specialist for accelerated change within organizations, VEQTOR successfully
helps organizations transition from traditional qualification to an integrated risk-based C&Q approach. We do this by actively building trust with QA through
thoughtful application of the first three strategies.
Our PMs and SMEs include QA in Resources Planning, Risk Management, and Daily Updates. Project tested models enable a win-win trusting connection
between QA and your project team. This increases the maturity levels of your organization’s quality systems. Strengthen existing quality systems through
robust engineering change management – by providing greater visibility and control of changes impacting process throughout project timeline and system
lifecycle.