The Tools

The Tools

A better solution. Delivered.

Validation is a given.

Go beyond the givens.

Line of Sight—Process Control

Developed by ValSource, the Line of Sight process control philosophy enables design, planning and implementation of essential risk based approaches. Line of Sight’s unassailable scientific principles generate practical, efficient procedures to evaluate and solve complex manufacturing problems.

  • Understand the product, the process and the variables.
  • Embark on manufacturing with supreme confidence.
  • Focus on the problem. Simplify the complex.
Process Validation

The Life Cycle Approach to process validation, leverages information obtained during process design to prepare effective, process qualification testing plans.

The S3 method ensures “right-sized” testing, sampling and batch quantity, combining science, statistics and strategy to apply risk, knowledge management and best practices to the process validation lifecycle.

The C2 method is one element in ValSource’s total S3 approach. C2 is a simple, powerful technique for answering the most commonly asked questions. C2 delivers Confidence and Coverage. Directly link the number of samples to product knowledge and the relative risk.

Risk Assessment

Condense the time between creation of risk assessments and risk-based approaches. ValSource’ strategic and tactical QRM systems are tools, truly unique to our industry.


The Interventions Risk Evaluation Model, or I-REM™ risk assessment tool is a risk assessment method designed to identify, evaluate and rank aseptic process interventions in a simple, repeatable, logical manner. I-REM™ uses a key word approach to risk assessment models.


The Environmental Monitoring Risk Evaluation Model, or EM-REM℠ risk assessment tool was created using the same principles as the I-REM™ model. EM-REM℠ establishes a logical risk based approach to the evaluation and selection of environmental monitoring sites.


The integrated methodology, technology and human resources we levy are dictated solely by the need.

The integrated approach makes you better. The integrated approach makes ValSource better. Champions of innovation, our process continually evolves to better meet your needs.


ValSource’s control and information management software.

Project Information Management System (PIMS)

A web-based project information management system.


A web-based timesheet entry and cost analysis application, MarkTime incorporates into your company website.


ValSource’s fulltime, vested employees are your fulltime, vested team members.

Validation. Delivered. This is the finish line we reach.