Gap Analysis

Gap Analysis

GxP Solutions can provide Gap analysis services to lower risk and bolster decision-making for the future.

A Gap analysis should be performed for all GxP-controlled documents (e.g., procedures, work instructions, and forms) to ensure these controlled documents reflect current regulatory requirements and currently-in-use process steps.

A Gap analysis should be performed for regulatory guidelines such as data integrity and risk management. To eliminate non-compliance, as well as controlled documents relating to the following GxP disciplines (e.g., GCP, GLP, GCLP, GVP, GMP, GDP, and CSV).

GxP Solutions can perform the following activities:

• Harmonizing procedures across facilities
• Identifying regulatory gaps in current procedures
• Correct SOP content or write new procedures based on audit findings.
• Developed a CAPA plan to correct identified gaps.
• Implement and monitor the action plan until completion.