Valineering™ - Validation Engineering

Orion Engineering, PLLC, developed the concept of Valineering™ after fifteen years of validation and design experience.  This experience indicated that the pharmaceutical industry was paying twice for the same knowledge, design and validation.

Key Benefits

During the process of developing the design, the engineer makes assumptions and does calculations to create a process, which matches the needs of the pharmaceutical facility.  During this process the engineer becomes intimately familiar with all aspects of the process and equipment.

Logic dictates that the engineers, who have a thorough knowledge of the process and equipment, create the testing required to validate the system.  They have the most knowledge of the system and have specified the equipment.  The pharmaceutical company has paid for the development of this knowledge.  The typical validation project requires that the company pay again for someone else to learn and understand the installed systems.

Why pay a second time for someone to understand the facility when the design engineer already does?

In the typical validation project someone has to sort through all the manuals and drawings left after construction to create a History File. During the design phase the engineer has touched each manual and each drawing and has a thorough knowledge of how the process works.

Why not put all this knowledge, for which you have paid so much, to work?

Orion Engineering’s approach is to have the design engineers begin the process of creating the History File as they proceed through the design phase.
 

1. Design engineers create the IQ and OQ.

Pay for knowledge accumulation only once and maximize the value of your expenditures.

Consider the benefit of reviewing the design with the protocols in hand; this allows you to change the design while it is still on paper.

2. Design engineers develop the criteria for PQ during design.

Begin the validation process early and increase your input  into the design process.

3. Design engineers develop the History File during the design phase.

Save money by handling the documents one time and receive your History File with the design.

4. Maximize the dollars you spend on design and reduce the dollars you spend on validation.

All of the required validation test questions occur during the design effort and the engineer answers them in order to complete the design.

Why do this twice?                                                              

5. Reduce the length of the validation process

Validation begins during the design phase and execution begins as soon as construction is complete.

Worried about "third party validation?"

Orion engineering can prepare the protocols for your approval and someone else can execute the protocols.  You still benefit by using the knowledge for which you have already paid.

Worried about conflicts of interest?

Orion Engineering's staff of design engineers are Registered Professional Engineers in the mid-Atlantic states and will do nothing to endanger their licenses.  Our goal is a cost effective project with repeat clients.

Worried about the technical competence of your third party validation specialists?

Orion engineering will provide a Professional Engineering review of any documentation prepared by others.

Worried about our level of expertise?

Orion engineering will gladly provide resumes for all of our staff.

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Last modified: 12/21/04