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Holistic Approach

The VISTX approach to performance improvement is focused on driving rapid deployment of improved processes and technology for both short-term and long-term gains.

Partnering with you throughout the initiative, the VISTX Business  Performance Improvement methodology is meant to improve your customer’s experience, optimize processes and reduce costs and time to and improve compliance.

Our commitment is to deliver real results, often within weeks, based on our approach to delivering solutions.  Our team of seasoned consultants, domain experts and compliance professionals will bring a deep understanding of all aspects of business and compliance and a reputation for integrity in all we do.

Goals

When we started VISTX, we started it with a promise to be different than your standard consulting company who have one approach and methodology for each client.  

We wanted to be different…focused on results…with agile processes easily tailored for each individual company.  First and foremost, we want to learn about your objectives for the initiative as well as your overall goals as an organization. 

We want to be your trusted partner and advisor working closely with you to get the results you expect and need.

Process

After understanding your goals, we work closely with you to streamline your processes.

A process, in this case, is a series of activities or purposes designed to produce the desired result.

VISTX Process improvement involves the practice of identifying, analyzing and improving existing business processes to optimize performance or simply improve quality and compliance utilizing various tools and techniques.

Technology

At VISTX, we believe the role of technology is critical to improving your business processes.  In fact, it is the key enabler.

Consequently, we utilize technologies,  like the Cloud, in our redesign or your business processes in order to streamline and improve the efficiency  as well as improve the collaboration with your internal team and customers.  This includes new technologies as well as integration between new and existing systems.

Procedures (SOPs)

Documented procedures are essential to compliance with FDA regulations.  VISTX works with you to identify areas where procedures are needed, based on risk, and helps create these procedures, as needed.

Training

The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management procedures/policies to CFR requirements. The agency expects companies to establish comprehensive procedures that detail how staff members will be trained but also complies with the QSR record keeping requirements.The requirement for training is defined in 21 CFR 211.25 for pharmaceuticals and 21 CFR 820.25(b) for Device companies.

Pharmaceutical companies need to ensure that employees and contractors have the education, experience and training to properly complete the assigned tasks.

Device companies are required to establish procedures for identifying training needs and ensure that personnel is appropriately trained to perform their assigned tasks. Company training should ensure employees, including staff members specifically involved with verification and validation activities, are made aware of defects issues that could result from the improper completion of their responsibilities.

The common thread for both of these regulations is that training must be documented. Generally, FDA investigators will check training records to verify that a company’s training program is adequate and can issue Warning Letters if the training is found to be inadequate or incomplete.

Compliance

Complying with regulations as well as internal procedures is an important part of our methodology.  We assign domain experts to work with your team to help ensure these new changes meet your compliance needs.

VISTX helps by doing assessments, defining gaps and working with you to document a plan for how, and when, you plan to be in compliance.  These plans are critical during an inspection to showing you have done your due diligence and are working to overcome any deficiencies.

Project Management

Our Project Managers are experienced and will work with your team to ensure delivery in a timely and cost-effective manner.  This includes:

  • Conducting Weekly Status Meetings
  • Creating Weekly Status Reports
  • Monitoring and controlling the project throughout the process
  • and working g with the Management to ensure project goals are being met.

Change Management

Ensuring that the project delivery is well received by the organization, Change Management is an integral component to our projects management methodology.  By utilizing our methodology, change management help ensure the successful deployment of the new processes and technologies.

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