Analyzing your facility designs and validating your manufacturing decisions

Under this arm of our quality and compliance services, we focus on your production facilities layouts, flows, process and utility aspects, and the selection of systems for manufacturing your products.

For new and existing facilities, we can assess and guide the layout in compliance with the regulations as a cost-effective method of avoiding unnecessary construction or changes. In conjunction with this, we are equipped with the expertise to evaluate the selection, commissioning, and qualification of machines and laboratory equipment (including calibration and validation) required to safely and effectively produce your medicines.

We do not stop at only setting up the engineering aspects of the facility; we also dedicate teams of experts to define, implement, validate, and maintain your facility’s computerized systems. Furthermore, we provide technical assistance for process cleaning and sterilization validation.

At ProductLife Group, we approach the manufacturing facility holistically, ensuring that your facility and machinery comply with the industry’s standards and regulations for economic and time-saving commercial production. We are here to engineer your success and the success of your medicines.

Our engineering consulting, qualification, and validation services include:

  • Facility design review
  • HVAC & utilities commissioning and qualification support (URS, risk analysis, FAT, SAT, DQ, IQ, OQ, PQ, calibration/validation)
  • Equipment selection, commissioning, and qualification support (URS, risk analysis, FAT, SAT, DQ, IQ, OQ, PQ, calibration/validation)
  • Computer system validation (CSV) – IT/IS system design strategy, implementation and validation support
  • Equipment, cleaning, sterilization, and process validation support
  • Support in writing all sets of qualification documents, protocols/reports, tests execution, and non-conformity management

PLG creates solutions to address our client’s needs.

We developed a complete set of services to address your CQV and CSV challenges. Our dedicated and trained teams of experts can support your projects from URS until the validation reports.

Our key figures

100+

references of CQV or CSV projects.