Blue Bell Consulting (BBC) offers a diverse range of GLP auditing services that can help your company ensure continuing compliance with regulatory requirements and prepare for a regulatory audit. We have extensive experience in performing highly independent and impartial third-party audits for our clients within the pharmaceutical and biotechnology industries.
In addition to GLP auditing, BBC can provide GLP compliance consulting service. It will be conducted in accordance with FDA抯 requirements (21 CFR Part 58 with its interpretations). We will support our clients in building an overall cGLP - compliant quality system in terms of hardware, software, and personnel.
We conduct Pre-Regulatory Inspection Audits, working with quality and regulatory specialists in your organization to analyze current policies, practices, SOPs and to observe daily work behaviors. We will produce observations and suggestions which, when correctly implemented, can better prepare your organization for an FDA audit.
We verify and assess through audit procedures compliance with FDA regulations to assure the laboratory/facility is in compliance with the appropriate guidelines and regulations. These audits are conducted to standard operating procedures to assure compliance. This audit includes clinical and laboratory facilities, procedures and practices.
We independently audit Contract Research Organizations to assure that they can offer you the quality service you expect. In addition we can monitor specific studies placed at a Contract Research Organization.
We provide guidance on how computer systems should be validated to meet cGLP requirements and/or provide highly independent audits to assure your computer systems are in compliance with the FDA requirements.
We provide cGLP Compliance Audits to you on a one time or annual basis. We conduct highly independent and impartial audits and provide reports to you with suggestions for improvement.
We train your personnel and help them to prepare and pass regulatory and corporate audits and inspections successfully.