Inner Banner

Regulatory Audits

VQS designs audit and corrective action plans to accommodate our client’s needs, including MHRA, EMEA, and FDA regulations. We offer the following services but not limited to:

  • Internal Audits
  • Pre-Approval Inspections
  • Contract Manufacturing GMP Audits
  • Vendor Audit
  • API Manufacturer Audits
  • SOX Audits on IT Systems

During our audit process, we evaluate your existing quality systems, and provide an exact assessment on the company’s various systems. VQS then recommends a plan of corrective action, which allows the company to achieve the quality assurance required by the respective regulatory agencies. A pharmaceutical auditing plan may include corrective actions on:

  • Documentation and Record Control
  • Change Control
  • Manufacturing Process and Equipment
  • Training
  • Validation and Qualification

The elements and steps involved in the audit process may differ depending on the type of audit required and its applied regulatory standards. VQS will work with clients and takes an active role to ensure corrective actions are implemented to remediate the gaps identified during the audit. The goal of having a Quality System is the consistent production of safe and effective products and ensuring that these activities are sustained. A robust Quality System will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions. Pharmaceutical auditing expertise includes writing and review of validation policies, guidelines, site master validation plan and SOP from design qualification to performance qualification steps.

Our Books

Governing Cloud Computing
( Book 1 )

The federal government is not in the business of developing new technologies, but they are in the business of investing in them. If you are planning to develop, computer-based products and Read More

Price $64

Computers, Information and Laws
( Volume 2 )

Regulatory Agencies have developed a set of expectations for companies who develop and operate computer systems in regulated spaces. Read More

Price $122