A Single Point of Truth for Engineering Data

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

Manage all data in one location from anywhere

Ensuring engineering information data-driven as opposed to document-driven. Traditional document-based systems require managing data in multiple locations and in various document types which is time consuming, inefficient, prone to error, and labor intensive.

Design Quality into your manufacturing systems

Quality by Design is pulled into the engineering space, ensuring manufacturing systems are designed to satisfy product and process requirements and are fit for their intended use. This solves a common problem for companies in their ability to adequately demonstrate this to auditors and regulators.

Track all requirements and specifications efficiently

Providing a robust and streamlined approach to implementing engineering projects Right First Time, that significantly reduces project costs and unnecessary rework speeding the time-to-market for new products.

Assess changes and manage risk seamlessly

Providing a thorough and consistent system for managing operational changes with an embedded, robust Engineering Change Management workflow for design review and risk assessments, a key component to overall Quality Risk Management programs.

proEngQbD & Engineering Information Management

Watch to learn more about how proEngQbD provides value to customers through a more flexible and agile approach for developing and managing engineering data than traditional document-based systems.

A Single Point of Truth for Engineering Data

Generating and managing engineering deliverables more efficiently helps our clients implement projects Right First Time

Modeling Manufacturing Systems

With proEngQbD, models of a manufacturing system can be created for each aspect:

  • Equipment & Instrumentation
  • Automation & Controls
  • Single-Use Components & Assemblies
  • Procedural Documents

Generate Engineering Deliverables

With proEngQbD, engineering deliverables can be generated quickly and updated automatically.

  • Electronic Process Descriptions (ePDs)
  • Process Flow Diagrams (PFDs)
  • Piping & Instrumentation Diagrams (P&IDs)
  • System & User Requirement Specifications
  • Design Specifications
  • Functional Specifications
  • Configuration Specifications
  • Equipment/Component Data Sheets
  • Single-use Component Drawings
  • Facility Fit Assessments
  • Design Reviews
  • Risk Assessments

Applications & Use Cases for proEngQbD

Drive greater efficiency and speed into your Engineering projects. Here are some of the applications where proEngQbD has been used by clients.

  • Application 1
  • Application 2
  • Application 3
  • Application 4

Tech Transfer Existing Facility

When new products and processes are introduced to an existing manufacturing facility, process changes need to be evaluated on all existing manufacturing systems.

proEngQbD ensures at each design stage of the project that all…

  • Product and process requirements are satisfied by the design of manufacturing systems
  • Critical aspects of manufacturing systems are appropriately addressed and linked to product and process requirements
  • Risks to product quality and patient safety have been identified
  • Unacceptable risks are mitigated by design or by other means
  • Engineering documents and deliverables are generated from a single point of truth
  • Verification activities (Qualification) will focus on critical aspects identified
  • Engineering Change Management captures the full scope, impact, risk, and execution of the project

New Process, New Equipment

When new products or processes are developed, requirements from product & process knowledge drive the design of new manufacturing systems and ensure manufacturing systems are designed Right First Time.

proEngQbD ensures at each design stage of the project that all…

  • Product and process requirements are pulled through from source documentation
  • Critical aspects of manufacturing systems are appropriately linked to product and process requirements
  • Risks to product quality and patient safety are identified upfront
  • Unacceptable risks are mitigated by the design or by other means
  • Engineering documents and deliverables are generated from a single point of truth
  • Verification activities (Qualification) will focus on critical aspects identified
  • Engineering Change Management captures the full scope, impact, risk, and execution of the project

Engineering Project Management

When engineering projects are required in an existing facility, all changes are assessed on existing products, processes, and equipment. proEngQbD provides an embedded Engineering Change Management workflow to properly document, assess and manage change on existing manufacturing systems.

proEngQbD ensures that all engineering projects in existing facilities capture each of the following…

  • Product and process requirements of the existing facility are identified
  • Critical aspects of existing manufacturing systems are appropriately assessed for any engineering change
  • Risks to product quality and patient safety are identified
  • Unacceptable risks are mitigated by the design or by other means
  • Verification activities (Qualification) can than focus on only the critical aspects identified and impacted by the project
  • Engineering documents and deliverables are generated from a single point of truth
  • Engineering Change Management captures the full scope, impact, risk, and execution of the project

Engineering Information Management

For any size organization, managing and accessing engineering data is crucial for maintaining operations. proEngQbD provides a single point of truth for all engineering data that can drive greater efficiency and speed into your engineering projects.

proEngQbD ensures that all engineering data and the following deliverables are managed in one location…

  • Electronic Process Descriptions (ePDs)
  • PFDs, P&IDs
  • System and User Requirement Specifications
  • Design Specifications
  • Functional Specifications
  • Configuration Specifications
  • Equipment/Component Data Sheets
  • Single-use Component Drawings
  • Facility Fit Assessments
  • Design Reviews
  • Risk Assessments

PDS Story

Process Design Solutions provides state of the art, best in class, process engineering solutions and services to the biopharmaceutical and medical device industries.




“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      




PDS Approach

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

PDS’s deep subject matter expertise combined with our innovative solution, proEngQbD, helps companies deliver projects Right 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.