QA & Regulatory Support

The QA function performs immensely critical duties in medical device companies which are all subjected to scrutiny by a variety of regulatory agencies. For many of them it becomes a do-or-die situation for sustenance of their business. This is more so because there is, unfortunately, a dearth of good, qualified and experienced people in the areas of QA.

 

We at Alceon can provide you with the support to maintain your QA and RA functions exactly as the regulatory agencies need them to be maintained.

 

Some of the areas where we can support you are:

• Quality Objectives: setting appropriate objectives and indicators to monitor your processes, analysing data periodically and setting up dashboards for management to review
• Internal Audit: conducting internal audits at pre-defined frequency
• Data Analysis: analysing data trends that arise from various processes like manufacturing non-conformities, supplier performance, customer complaints, internal and external audits
• CAPA: conducting root cause analysis and identifying effective corrective and preventive actions
• Supplier Evaluations: conducting periodic supplier evaluations and supplier audits
• Audit Response: preparing response to external audit non-conformances

 

Contact us for a one-to-one discussion on how we can support you to overcome the QA challenge!