knowledge associates

Quality. Compliance.

GMP Consultant

Kuala Lumpur, Malaysia

IT and Computerised Systems Validation

Validation of utilities plants, processes, cleaning, laboratory equipment, spreadsheets,...

Quality Management System

GMP Training

Facility design and improvement

Call +60 1111 00 8486

or email david.paspa@knowledgeassociates.asia

Regulated industries are filled with uncertainty.


What is actually required?


How much is enough?


What will the Auditor focus on?


What is 'best' practice?

There are many things to be done
in pursuit of your business goals

Some regulations help you achieve them.
Some do not.



Some businesses have become distracted by their interpretation of the regulations

This is evidenced by the vast extent of compliance activities they put in place and yet they continue to have compliance issues and "audit stress".



Your business should be driving your compliance activities, and not the other way around

Signs that compliance activities are driving your business


Compliance requirements seem to be a moving target


More and more resources are tied up and costs escalate


No product quality or bottom line improvement

What if compliance worries just disappeared?

Experience

We have over 26 years of experience in international GMP regulated industries.

Secure

We value the trust our clients place in us extremely highly and take confidentiality very seriously.

Fundamental Science

Our approach is pragmatic and simple. Anybody can understand it, even with no prior GMP knowledge.

Measurement

We provide a clear and unbiased assessment of your current compliance status and what you need to do to improve.

The hard parts made easy


Maintain
information
certainty


PIC/S, EU and US FDA
compliance


Risk
based
decisions


Eliminate
doubt and
waste


Capacity
balanced
improvements


Quality
improvement
focused

Lean Compliance

We apply the principles of Lean and Six Sigma to your quality and compliance efforts and Systems Theory to your overall business management.

This results in sharp focus on the points of greatest leverage in your business.


Increased Velocity

This focus and "less is more" approach increases the rate at which your organisation's compliance improves.

We are professional engineers. We understand the technical detail "under the hood" of your systems and processes.
knowledge associates

Get started now

Call David Paspa on +60 1111 00 8486
or email david.paspa@knowledgeassociates.asia


We are fast, so you pay less for your compliance efforts. Let us prove it to you.