OUTSOURCING ACTIVITIES | Business Excellence Consulting, Inc

OUTSOURCING ACTIVITIES

BEC is providing support in the form of outsourced programs to regulated companies for the following elements of their quality system:

Training Program
Internal Audit
Supplier Audit Program
Complaint Investigation
Investigation of Deviations/NCR/CAPA
APR/PQR

Every day more companies are discovering the value and benefit derived from outsourcing specific critical activities to specialized providers such as our company. We provide our outsourcing clients with real and proven expertise in the FDA-regulated industry, 24/7 support, very affordable and cost-effective fees.

As an example, our outsourcing value model for the self-inspection program of a typical pharmaceutical plant includes the following elements:

Developing and maintaining a risk-based and compliant internal audit program for the site
Subject matter expert auditors with an average of 25+ year in the FDA-regulated industry
Our audit process is becoming accredited under ISO 17020:2012
Full support during external audits/inspections regarding internal audit function
Follow-up of CAPAs generated after internal audit findings
In total, we provide 50-days of audit during a calendar year covering all the elements of the quality system:

* Data Integrity (manual, electronic, and hybrid systems)

* CSV

* QC analytical lab

* QC microbiological lab

* Critical systems and utilities

* Calibration and PM program

* Stability program

* Master validation program

* Quality system

* Production system

* Investigation and CAPA system

* Complaint handling

* Management controls

To learn how your company can benefit with our expertise, certified auditors and our affordable fees, contact us at info@bec-global.com