Regulatory Services

Life Sciences

BPS is a full service contract compliance and validation firm specializing for Life Sciences Industry (Pharmaceuticals, Biotechnology, Medical Devices and Clinical Trials) that must comply with FDA Regulations, GxP, 21 CFR Part 11, EMEA and other governmental regulations. We understand cGMP's, GLP's and GCP's and provide audits, validation and compliance support for some of the best companies in the business. We also specialize in implementation of GAMP 4/GAMP5 guidance.

In the ever changing FDA regulated industries, you can count on BPS as your partner to ensure all necessary validations and compliance records are comprehensive, controlled and defensible and maintained as necessary.

For more information about our compliance services for life science industry - please click here.

Finance Services

Sarbanes-Oxley - IT Assessments for Compliance

BPS leverages its knowledge of IT across a multitude of verticals resulting in a practical, effective and efficient approach for assessing IT general controls for compliance with Sarbanes-Oxley (SOX). BPS has knowledge and experience in the standards and guidelines specified by COSO, COBIT and PCAOB.

The following outlines the six (6) steps in BPS Assessment process:

  • Identify Significant Processes. (SP)
  • Document SP
  • Define SP Key Control Objectives
  • Define SP Control Activities
  • Perform Testing
  • Disclosure

IT Procedures & Software Quality Control

BPS has extensive experience in the creation of documented procedures for diligently managing financial Information Technology systems. These documented Standard-Operating Procedures incorporate security, disaster recovery, installation qualification and operational maintenance and support. In addition, BPS has significant experience in developing and executing tests to ensure the reliance and integrity of financial IT systems.