CAPA is at the heart of any quality application as it reduces audit time, decreases risk of product recalls, improves product quality and safety, increases customer success and helps to ensure compliance. Auditors consider CAPA systems to be critical for any FDA, ISO or other global GxP regulations, and an efficient CAPA system will improve processes, uncover trends, solve process problems, and provide new preventative actions. Intellect’s CAPA software system is highly configurable solution that can be easily adjusted to meet your specific process and automation needs.
CAPA management systems will reduce the risk of lost data and meet compliance with industry regulations including GMP, ISO 9001 and 14001, TSCA, REACH, etc. CAPA process workflows provide a controlled environment and reduce the risk of repeat issues by ensuring that defined CAPA solutions and processes are met. For example, medical device companies must adhere to FDA 21 CFR 820.100 and establish a CAPA process within their QMS to capture, review, approve, control, and retrieve closed-loop processes.
Increasing CAPA process efficiency, including documentation, approvals and signatures will decrease cycle time and operation costs. Intellect’s CAPA software systems are integrated with other quality processes, such as change control, customer complaints, and audits.
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