With constant research many new devices and methodologies are being invented. And Technology makes it critical to make sure that there are proper regulations for the improvement of medical sciences. It is a true concern on the part of the govt. that they strive for quality and perfection. Medical devices play a very important role in diagnostic processes. Thus, it is important on the part of the government to maintain the highest standards to regulate them. But it is not always easy to maintain the highest standards. On many occasions, the concerned firms fail to retain such standards that are specified by the concerned government authority. One of the major causes of such failure is a lack of knowledge. But such a scenario will be successfully battled with correct consulting and training processes.
This is why the pharmaceutical industry is often used as the benchmark to enhance the CAPA system. CAPA or Corrective action and preventive action is a method that is followed by organizations to eliminate damaging results, by concentrating on the desirables. It comes under the scope of good manufacturing practice (GMP) and also the ISO standards. The key features of this process include analysis of the root cause of the problem, and implementing specific actions based on such analysis.
Some of the steps of the CAPA system include –
- Root Cause Analysis
- Identification and Adaptation of Corrective Action
- Development and Adaptation of Preventive Action
- Implementation of the Preventive Action
Orcanos Software comes into existence in the year 2005 by Zohar Peretz and Rami Azulay. The only company that gives integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, which specializes in the CAPA Medical Device industry.
The unique thing about us is our years of proven experience in a regulated hi-tech industry, working with medical device manufacturers and other high-tech companies, and assisting them in building their operational excellence.
Orcanos CAPA system includes Tractability to other quality processes, such as FMEA, ECO, Complaints, Training, Verification, etc or much more. With fully Customizable CAPA forms: no more paperwork. And:
- Document Generator
- Integrated Risk Management
- Electronic Signature
- Fully Customizable
- Personal Dashboards
- Real time Alerts
FMEA (Failure Mode and Effects Analysis) is a management activity intended to assess actual and potential problems, assign a risk factor and choose a course of action. This method is used in many industries like automotive, FMEA Medical Device manufacturing, aerospace, and chemical processing.
Good Orcanos CAPA software systems provide the tools for this type of advanced root cause analysis to support conforming corrective and preventive action processes and customer satisfaction.
To know more about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/