Why have a System Audit Readiness Assessment?
A System Audit Readiness Assessment can provide you with peace of mind that comes from knowing that your system is ready to withstand inspection from regulatory agencies, such as the FDA, and prospective customers.
If your system has never been inspected, a System Audit Readiness Assessment can provide you with a concise, prioritized list of actions that will get your system and supporting procedures in shape. When the actions are completed, you'll be ready!
Don't let lack of system compliance stand in the way of gaining new customers, launching new products, or obtaining regulatory approvals. Know your strengths and address your weaknesses.
What is a System Audit Readiness Assessment?
Praxis offers System Audit Readiness Assessments at your site to determine whether or not your system is ready for an inspection by a regulatory agency or customer.
Experienced software quality assurance and validation professionals follow the risk-based GxP principles laid out by PIC/S, ICH, EMA and the FDA, to prioritize the areas to be assessed for compliance. We know which areas an auditor will be most likely to target.
Prior to the System Audit Readiness Assessment, a Praxis representative will work with you to determine the specific regulations with which you must comply. This will keep the assessment focused on the regulations that are most important to you and your customers.
A typical on-site System Audit Readiness Assessment takes 1-2 days; the actual amount of time will depend on the number and complexity of systems assessed. System Assessment topics include:
- Policies, processes, procedures
- Quality assurance program
- Computer system validation
- Compliance to procedures
- Defect CAPA
- System Training
- 21 CFR Part 11 compliance
- Compliance with other applicable regulations and guidelines, such as 21 CFR 820, 21 CFR 210/211, Computerized Systems used in Clinical Investigations (FDA), General Principles of Software Validation (FDA), Eudralex Annex 11, ICH Q7A and Q9, Good Practices for Computerised Systems in Regulated "GxP" Environments (PIC/S)
What will you receive from a System Audit Readiness Assessment?
At the end of the System Audit Readiness Assessment, you will receive a detailed Assessment Report and Compliance Action Plan.
- The Assessment Report will identify where your system is compliant and where it's not compliant. Areas of non-compliance will be categorized as either "critical", "major", or "minor" in alignment with a risk-based compliance program.
- The accompanying Compliance Action Plan will provide you with the list of specific, prioritized actions that you can take to approach your next inspection with confidence.
Contact us today to get started!