Audits

Myers Quality Consulting offers a variety of audits for life science companies throughout the United States and around the world. Curious how a GLP or GCP audit would work for your company? Here’s how we can help your business:

Our services include:
• Scheduling your audit on mutually agreeable dates
• Working with you to determine the audit purpose and scope
• Sending an audit confirmation letter to confirm the audit dates, location and expectations for available documentation and participants
• Conducting an opening meeting for introductions, review of the audit scope and to answer any questions
• Performing a comprehensive audit that includes interviewing employees, reviewing written procedures and records, observing process (when possible) and applying all against the regulations and industry standards
• Presenting the audit observations at the close of the GLP/GCP audit
• Writing an audit report summarizing what was covered and the audit observations
• Providing you with the draft audit report within five (5) business days after completion of the audit
• Sending the final, approved audit report upon completion
• Generating an audit certificate for the client as declaration the audit occurred
• Preparing a request for corrective action that will be sent to the auditee

We can help with both short-term projects and ongoing quality support, including:

• Designing, developing and managing quality systems
• Training in GCP/GLP, writing effective SOPs, deviation management/root cause analysis and other topics
• Project management
• SOP development and writing
• Evaluation of corrective actions
• Due diligence audits

We offer the following audits: