Auditing
Auditing is a management tool used to verify that systems and processes are compliant and suitable to achieve objectives and effective. Well executed audits allow manufacturers to provide high quality product to customers and to improve business performance.
Bestech audits provide an experienced, objective and unbiased look at your operation. We collect evidence and data to seek whether requirements are being met, we observe personnel and conduct interviews. We compare actual practice to the requirements or standards.
Why Audit?
Proactive organizations, look to stay ahead of the potential threats to the business such as unidentified quality concerns and inefficiencies in practices.
An added advantage to high quality audits is that they prepare a company for the challenge of a scrutinizing inspection by regulatory authorities.
Audit Services We Provide
Systems Audits
Systems audits determine if your requirements are being met – e.g., corporate quality manual/policies, standards, regulations.
- We identify system and process inefficiencies.
- We identify system and process effectiveness.
Mock GMP Audits
Are you ready for the time the regulators come in the door?
Our Mock GMP audits allow you be one step ahead and prepared for that inevitable day.
503B Pharmacy Audits
We have direct experience with auditing many Outsourcing firms. We are approved by some states as providers to perform these audits in lieu of a current regulatory inspection in order to continue doing business in those states.
ISO 13485 / 21 CFR Part 820
We help you be ready for Medical Device regulatory inspections through assistance with your internal audits and vendor auditing.