Niamex staff has been involved in the support of many international audits including MHRA, FDA and from countries using PIC/S. Our main focus has been support in the field of Data Integrity, 21 CFR Part 11 and Computer Validation.
If you have any need with the following activities, one of our resident industry experts will be available to help you.
We can help you with any of the following:
Prior to buying software of computerized systems which are critical to the business a vendor audit should take place. This will let you know if the software or system that you are buying has been developed using a quality framework, and is therefore suitable for use within the life science industry. We would be happy to conduct these audits on your behalf.
Preparation for Regulatory Audits:
If you have a regulatory audit on the horizon that has Data Integrity, 21 CFR Part 11 or Computer Validation implications, we will be happy to do a pre-audit to evaluate your computer systems for compliance.
Action Items Solution:
In the event that we find fundamental issues in your pre-audit, we will be happy to help you put in a remediation plan to solution the actions in a timely manner. These actions could range from the updating/creating of your procedures/work instructions or supplementary validation activities.
One of our resident industry experts would love to help you.
Don’t forget, at Niamex, our aim is to provide good value, practical advice and to seek a long-term relationship with our clients. If you feel we can be of service to you, please contact us