Who We Are

Our mission is to provide state of the art, best in class, process engineering solutions and services to the biopharmaceutical and medical device industries.

Our Story

“Unlike many other engineering firms, Process Design Solutions (PDS) focuses our process engineering efforts on product quality and patient safety. For over 10 years, Quality by Design (QbD) and its principles and concepts have driven our mission, vision, and values. PDS has invested in technology and innovation to drive QbD as a focal point of our core business. We have integrated this approach into our service model to deliver projects ‘Right First Time.’”

—Paul Stanovich, Managing Partner      



Our Values

As trusted advisers, we strive to provide the highest possible value in everything we do.

This means we ensure…
Quality in what we deliver, first and foremost
Value that exceeds our customers expectations
Integrity which is demonstrated every day

Our Approach

Our unique approach applies the concepts of QbD to improve all aspects of the process engineering function.

Our innovative solutions combined with deep subject matter expertise help companies deliver projects right the first time.


How We Do This

Listen. Plan. Deliver. By strategically focusing design efforts on product quality and patient safety, we extend the principles of QbD into the process engineering space for manufacturing systems, helping clients appropriately apply the principles of...

Quality Risk Management (QRM) via ICH Q9
Engineering Change Management (ECM) as a supporting process
Quality Systems (QS) to manage impact to critical aspects


Quality by Design (QbD, ICH Q8) is the systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

Listen. Plan. Deliver. Success By Design.

Services

PDS is a trusted partner providing clients expertise in:

  • Process Engineering
  • Automation
  • Engineering Information Management
  • Project Management
  • Program Management
  • Single-Use & Material Qualification

Process engineering in all phases for new, existing and multi-product facilities.

  • Front End Engineering Design (FEED)
  • Conceptual, Basic, & Detail Design
  • Tech Transfer & Facility Fit
  • Process Optimization
  • Engineering Project Support

Automation engineering in all phases for new, existing and multi-product facilities.

  • Control System Conceptual Design
  • Control System Specification, Design, & Implementation
  • Test-bed Development & Implementation
  • Computerized Systems Validation
  • Alarm Design & Rationalization

Driving greater efficiency for our clients in how they manage and generate engineering deliverables.

proEngQbD provides an innovative solution that is more flexible and agile than traditional document-based systems.

PDS provides comprehensive consulting services for COMOS Industry Solutions.

At a glance:

  • Reduced data complexity through central database storage of all plant information enables consistent access to all object-related data for any user
  • Reduction of process cycle times through close interaction between the engineering and operating phases
  • Optimal integration and coordination of all plant subsections involved in planning and operation

PDS offers you comprehensive consulting and technical support for customizations as well as training courses for COMOS users – and even more performance, quality and local presence. See our Solutions for more information.

Project controls to effectively manage their critical projects from conception through closure.

PDS partners both with clients and third party Providers to effectively manage project teams and project controls.

Our client’s projects range in scope and complexity however we treat each project by listening, planning, and delivering what is expected.

All phases of planning and implementing ASTM E2500 to manage all elements of the engineering and operational phases of the manufacturing system lifecycle and QbD.

  • ASTM E2500 Planning & Implementation
  • QRM Program Development & Implementation
  • Change Management
  • Design Review & Risk Assessment
  • QRM Consulting and Training

All single-use and material qualification activities.

  • Single-Use Program Development & Implementation
  • Requirements & Specifications
  • Leachables & Extractables Assessments
  • Component Failure Evaluation & Risk Assessment
  • Material Qualification Consulting & Training

A Single Point of Truth for Engineering Data


An innovative solution for engineering Information Management (EIM) for FDA and other regulated industries. Providing a more flexible and agile approach for developing and managing engineering data.

View SolutionPlay Video

proEngQbD is powered by Siemens COMOS Industry Software.



A Single Point of Truth for Engineering Data


An innovative solution for engineering Information Management (EIM) for FDA and other regulated industries. Providing a more flexible and agile approach for developing and managing engineering data.

View SolutionPlay Video

proEngQbD is powered by Siemens COMOS Industry Software.


COMOS -
Making Data Work

Better quality decision-making throughout the plant’s entire lifecycle

COMOS provides the process industry with a seamless flow of information based on a globally consistent database – integrated across all disciplines and all phases of a plant's lifecycle. This is possible thanks to the systematic application of object orientation. This means: In COMOS, all data relating to the same component form a unit – an object. Changes to object specifications are stored in the central COMOS database so that the updated data is available everywhere and at all times. Plant engineers and operators can access data that is always up-to-date – in real time and independent of time zones. That creates the basis for maximum decision-making reliability – and, thereby, for considerably greater productivity.


COMOS benefits at a glance:

  • Integrated and consistent plant management
  • Flexible application options in all disciplines and all lifecycle phases of a plant project
  • Optimal integration and coordination of all plant subsections involved in planning and operation
  • Reduction of process cycle times through close interaction between the engineering and operating phases
  • Reduced data complexity through central storage of all plant information enables consistent access to all object-related data for any user
  • Open system architecture for perfect adaptation to operation-specific requirements and integration of third-party systems into existing IT landscapes

The high flexibility of COMOS solutions can be individually tailored to your specific needs – and that's where we come in. As a company with extensive industry-specific know-how, we at apply all of our expertise to benefit your plant. We offer comprehensive consulting and technical support for customizations as well as training courses for COMOS users – for even more performance, quality and local presence.

More InformationSoftware Solutions for Optimized Plant Engineering

COMOS - Making Data Work

Better quality decision-making throughout the plant’s entire lifecycle

COMOS provides the process industry with a seamless flow of information based on a globally consistent database – integrated across all disciplines and all phases of a plant's lifecycle. This is possible thanks to the systematic application of object orientation. This means: In COMOS, all data relating to the same component form a unit – an object. Changes to object specifications are stored in the central COMOS database so that the updated data is available everywhere and at all times. Plant engineers and operators can access data that is always up-to-date – in real time and independent of time zones. That creates the basis for maximum decision-making reliability – and, thereby, for considerably greater productivity.


COMOS benefits at a glance:

  • Integrated and consistent plant management
  • Flexible application options in all disciplines and all lifecycle phases of a plant project
  • Optimal integration and coordination of all plant subsections involved in planning and operation
  • Reduction of process cycle times through close interaction between the engineering and operating phases
  • Reduced data complexity through central storage of all plant information enables consistent access to all object-related data for any user
  • Open system architecture for perfect adaptation to operation-specific requirements and integration of third-party systems into existing IT landscapes

The high flexibility of COMOS solutions can be individually tailored to your specific needs – and that's where we come in. As a company with extensive industry-specific know-how, we apply all of our expertise to benefit your plant. We offer comprehensive consulting and technical support for customizations as well as training courses for COMOS users – for even more performance, quality and local presence.

More InformationSoftware Solutions

Clients