PTS - Engineering Programs

Project Engineering Programs

Project Engineering is an early step in the process to create a new process or facility, or modify an existing one. After provided with User Requirement Specifications, the engineers have to layout, design, specify, select, install, commission, and often help qualify the equipment. This process should not be done apart from the other departments charged with validating, operating, and maintaining the process or facility.

To comply with 21CFR 211.42, Design and construction features, an organization should establish procedures that incorporate reviews by relevant functions. Reviews that are better done when corrections can be made on paper, rather than the much more time-consuming and costly changes to bricks and mortar.

PTS has helped clients establish project engineering procedures that ensure appropriate reviews along the process, yet recognizes that the project to replace a WFI pump would not require as extensive a review process as constructing a new processing facility. Compliant, yet pragmatic, is the continuing theme in developing such procedures - a theme PTS always keeps in the forefront.

The link below provides an Adobe PDF version of a simplified Engineering Process Map indicating the interactions of other functions as a new project is implemented. PTS is ready to help your organization establish a sustainable program for controlling your Project Engineering function.

An Engineering Project Life Cycle Flowchart for the regulated industry

Please contact us at Engineering@PTSGMP.com for an electronic copy of our paper covering Compliance Aspects of an Engineering Program in the Regulated Industry