Kuala Lumpur, Malaysia
IT and Computerised Systems Validation
Validation of utilities plants, processes, cleaning, laboratory equipment, spreadsheets,...
Quality Management System
Facility design and improvement
Call +60 1111 00 8486
or email firstname.lastname@example.org
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?
We have over 26 years of experience in international GMP regulated industries.
We value the trust our clients place in us extremely highly and take confidentiality very seriously.
Our approach is pragmatic and simple. Anybody can understand it, even with no prior GMP knowledge.
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
PIC/S, EU and US FDA