Qualification Services
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At TRAQuE we often say our bread and butter is qualification. Whether you are looking to start up a new facility, make additions to an existing system, or bring your processes up to date with the latest industry and regulatory standards and trends, our consultants can help.

With extensive experience in the design, construction, qualification and start up or numerous facilities, our consultants can provide the right level of expertise and support to help your team deliver your project on time and on budget.
Our expertise encompasses all areas of qualification, including:
  • Facility & Utility Qualification
  • Warehouse & Shipping Validation
  • Manufacturing & Packaging Equipment Qualification
  • Laboratory Equipment Qualification
  • Process Equipment Qualification
  • Analytical Method Validation
  • Computer Systems Validation
We have extensive experience in delivering projects in line with ISPE Baseline, GAMP 4 & 5, ASTM 2500, as well as a multitude of multinational corporate standards and policies.
We can help provide turn key solutions to fully integrated teams working alongside your own staff. Working from the start of the project on a blank sheet of paper, through to helping sort the mountain of documentation at the end of a project, TRAQuE can support in each and all of the following aspects of the validation lifecycle:
  • Validation Master Planning and Risk Assessment for Validation
  • User Requirement, Functional, and Design Specification Development
  • Design Qualification & GMP Reviews
  • Commissioning and Plant and Equipment start-up
  • IQ / OQ / PQ Protocol preparation
  • IQ / OQ / PQ Protocol Execution
  • IQ / OQ / PQ Report preparation
  • Deviation Investigation and Resolution
  • Risk Assessment and Management
  • Change Management
  • Cycle Development
  • Cleaning Validation
  • Process Validation
  • Media Fill Validation
  • Integrated C&Q
  • Thermal Mapping
  • Turnover pack preparation
  • Document Management and Control
  • Environmental Monitoring
  • Steam Quality Testing
  • Calibration
  • Requalification

If you would like more information, please "Get On TRAQuE" and contact us.

Office Address



Our contact details in Singapore are:

TRAQuE Pte. Ltd.
51 Bukit Batok Crescent,
#08-25 Unity Centre
+65 6316 3885
+65 6316 3885

Our mailing address in Malaysia is:

TRAQuE Sdn. Bhd.
Suite 13-10, Level 13,
Johor Bahru City Square Office Tower,
106 - 108, Jalan Wong Ah Fook,
80000 Johor Bahru.

If you would like further information on our products or services, then feel free to contact us using the form below. We look forward to working with you.

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Please contact us if you would like further information on any of our products or services. We will get back to you as soon as possible.
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Latest News

TRAQuE Awarded bizSAFE Star

TRAQuE is pleased to announce we have been awarded BizSafe Star by the WSH Council.


Congratulations to the team and well done in the continued efforts in supporting safety.


TRAQuE Malaysia

We’ve always placed great importance on being close to our customers. The ability to provide local resources, respond quickly and be onsite as required has proven extremely valuable in the seven years since we began operations in Asia.


Protak Scientific Partnership
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We're delighted to be kicking off our partnership with Protak Scientific in Singapore. This revolutionary alternative to biological indicators for use when assessing VHP effectiveness is significantly quicker than current methods and can provide linear quantitative data, resulting in optimised cleaning processes and increased productivity.

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