AUDIT AND INSPECTION READINESS

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. * They help you to identify your strengths and weaknesses * Facilitates a comprehensive walk-through of your systems and procedures at strategic, tactical and operational levels * Do a critical analysis of the employees' awareness about the regulations * Shines light on the breach in your processes: timely remedial action for which can have epoch making role in your progress * Pinpoints at the weak links in the chain "The Trouble spots" thus enabling you to effectively channelize your resources 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.