Process Management

Tietronix has the knowledge and tools to accelerate your project technologies. While our expertise is in the medical field, including pharmaceutical, biotechnology, medical devices, and health care administration sectors, we can work in any arena.

With Tietronix you get to the right target faster, and with all the quality and compliance required the first time!

Whether your project deliverables are targeted to senior management, investors or consumers—you will find that Tietronix’ life sciences team offers an innovative approach to solutions developed using significant industry experience.

We have combined our proven TieFlow technology and industry best practices into solutions that are proven to accelerate the achievement of business results.

For your medical development project, we offer:

• visualization of your concepts through our graphics and 3D animation services,
• design control automation through our Medical Device Accelerator (MDA) tool,
• software development services (including serious games), and
• FDA consulting services.

Experimental Development Accelerator (XDA)

Insufficient rigor in pre-clinical study design often leads to unrepeatable research findings that do not translate into reliable human clinical trial results. Factors contributing to inadequate studies include insufficient understanding of experimental design and statistics, as well as a lack of access to experimental design guidance and statistical expertise. To address the challenges of pre-clinical study design, Tietronix is developing the “Experimental Development Accelerator”, or XDA.

Based on a system Tietronix developed for NASA to assist and govern the design of complex spaceflight software, XDA uses a process automation engine to lead the researcher through the essential decisions in formulating a research design, while informing the user at each step on methodological issues and best practices. The user is also led to develop specific plans for conducting and documenting the experiment in accordance with best practices.

Even if the user is not an expert in the subject matter, they can follow intuitive steps in a user customizable, adaptive learning environment while they master the art of pre-clinical study design. XDA can also connect users in real-time with subject matter experts to insure they achieve a quality study design.

Software Developer’s Assistant (SDA)

SDA is an engineering process automation tool that guides engineers through project specific standards, processes, and procedures. SDA breaks ‘mission-critical’ processes into the smallest steps possible and guides engineers through each assigned process step.

Some of the standard features of SDA are:

• Assists program and project management via dashboards and reports that supply real time monitoring and status of the project.
• Ensures process and best practice compliance.
• Automatically collects and analyzes metric information.
• templates and examples,
• best practices,
• references, and
• instructions and background information.

SDA is being used by NASA and Tietronix’ medical device development projects.

Medical Device Accelerator (MDA) – Quality Management System

Tietronix provides a web-based quality management software application that helps manage the life cycle of medical device products. This QMS application makes it easy to adhere to FDA regulations and compliance standards through built-in processes. Development teams are guided through each detailed task from concept to implementation with regulatory compliance and standards mapped into each process step.

Our quality management system, Medical Device Accelerator (MDA) provides the infrastructure that enables significant efficiencies and productivity gains and can reduce the key risks when bringing medical devices successfully to market. MDA achieves this through work-flow automation as part of an enterprise suite of tools.

Medical Device Accelerator provides a highly repeatable development process-an important contributor to quality, regulatory compliance, and efficiency.

Six Sigma and SDA

Tietronix’ SDA process automation tool supports Six Sigma and Lean Six Sigma processes. Tietronix’ Six Sigma Team, comprised of certified Black Belts, incorporated this automated process into SDA to facilitate ease of management and assist project teams with Six Sigma/Lean Six Sigma best practices for process improvement projects.

By combining the process into SDA, users can access the powerful features SDA offers. SDA for Six Sigma/Lean Six Sigma features include:

• Templates, detailed instructions, suggestions, and background information
• Increased project visibility, real time status, and project updates
• Ability to assign roles and tasks and provide email notifications and online alerts
• Automatic and real-time metrics capture
• Document management including version control and repository for artifacts
• Web-based portal allows access to project from distributed locations

The automated Six Sigma/Lean Six Sigma process supports both manufacturing and non-manufacturing projects and benefits both mature Six Sigma programs as well as organizations new to Six Sigma methods.

Bioastronautics Planning System Configuration Management (BPSCM)

Tietronix’ BPSCM software automates Configuration Control Board (CCB) functions commonly used in engineering programs.

BPSCM streamlines the management, operations, and administration of CCBs through process automation and is highly configurable to support a wide variety of operational profiles.

Implementation of BPSCM:

• Allows users to create and work on Change Requests (CRs) through the web interface.
• Provides access to real-time dashboards and graphical process views.
• Allows ease of scheduling meetings, tracking action items, etc., through a standard browser interface.
• Ensures process compliance of all users and board members.

Significant efficiencies and productivity gains have been reported as a result of BPSCM’s automation of process and administrative functions.

A large group measured a 333% efficiency improvement of their configuration management administration personnel. Users in general report higher productivity and preparedness levels.

BPSCM is being used by several organizations at NASA to manage changes to deployed software and hardware systems and flight procedures.