The recently released Pharmacovigilance regulations have insisted that all MAH in the EEA to perform regular risk-base audits of their Pharmacovigilance system and Quality Management Systems and to communicate any safety risks with regulators and health professionals.
Establishing an effective system of internal controls is mandatory to ensure that the resources are efficiently utilized to achieve stipulated goals and objectives. In the current scenario of stringent regulations, any nonconformity can hamper your progress.
Internal audits provide valuable insight to your management on the adequacy of internal controls.
Backed by years of experience of conducting such audits worldwide, our PV services encompass all your crucial activities and help you demystify your processes. This has a momentous role in enhancing your operational efficiency and braces you for external inspections.
Having faced an internal audit that will highlight the irregularities of the system, the next milestone which needs to be addressed is a well-structured remedial and preventive plan. Needless to say, this needs to be preceded by a critical root cause analysis.
A strategically planned CAPA has a multitude of advantages. Besides detailing the modus operandi of the plan, it will also specify the requisite timeframes for the same. These corrective actions may target your SOPs, and safety database or in some cases overhaul the organization as a whole.
Formulating CAPA is a tedious and exhaustive process and poor management can cause confusion and non-compliance ending up in a vicious cycle of clogged processes. The team at AWINSA Life Sciences with an in-depth knowledge of the regulations and processes is well equipped to conduct an adroit analysis of the audit/inspection finding which is the key to formulating a strategic CAPA. Undoubtedly, a weak CAPA can severely undermine the efficacy of the organization and defeat the whole purpose of conducting internal control and audits.
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