Inspection Readiness (IR)

Inspection Readiness (IR) is a process of preparing for an inspection by a regulatory authority such as the FDA. The FDA conducts official reviews of documents, facilities, records, and any other resources they deem to be related to the clinical trial, manufacturing, and operations. Every pharma company is responsible for inspection readiness by providing training to employees and ensuring their understanding and application of policies, standards, and procedures. Pharma organizations should allocate the resources to assure that inspection readiness teams are in place to manage activities before, during, and after inspections.

Inspection Readiness can be a daunting task, especially for smaller organizations. Court Square Group helps pharma companies prepare for regulatory inspections associated with an NDA or routine inspections and audits.

Court Square Group can support your Inspection Readiness in the following areas: 

• Conduct an internal audit and review your Quality Management System, Policies/SOPs, qualification, computer system validation and relevant artifacts to ensure adequate oversight and controls are in place.

• Identify and remediate gaps.

• Remediation services include helping to identify which SOPs need to be updated, which artifacts are missing or should be bolstered and whether retro-qualification or validation should be performed.

• Apply a risk-based approach as appropriate.

• Identify risk factors and apply them to the systems in place and the actual data being collected.

By proactively engaging Court Square Group’s team of expert life science Quality Management and Information Technology (IT) professionals, you can identify those systems most likely to generate audit findings. This proactive stance helps you ensure that the systems you are using are in compliance.

Most startup and early-stage life science companies do not have the necessary in-house staff with the proper training to meet the requirements of the FDA auditors. Court Square Group provides expert resources to satisfy your resource requirements and ensure inspection readiness.

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