FMEA Risk Analysis document template

$399.00

AN EASY WAY TO GET YOUR RISK ASSESSMENT APPROVED IN ONE SHOT!

  • Need to Complete your Risk Assessment on time?
  • Want to be sure your Risk Assessment document will pass a regulatory inspection easily?
  • Do not have enough budget to hire a consulting company to complete your Risk Assessment?

FROM TODAY YOU CAN HAVE IT ALL:

Be in full compliance with the FDA/ICH regulations in a short time and with minor costs.

 

Description

This FMEA Risk Analysis excel template defines all the required information based on the failure mode and effect analysis (FMEA).

The FMEA excel template for evaluating the process and identifying where and how it might fail, assessing the relative impact of different failures, and ensuring systematic identification, analysis, evaluation, and control of risks.

The Risk Analysis file enables monitoring the effectiveness of the control over risks and compliance with the FDA, Eu. and ISO regulatory requirements. The FEMA Risk Analysis is a pre-programmed xlsx file that enables easy usage and includes all Severity, Occurrence, Detection, and RPN definitions and ranking, Mitigations & CAPA, estimated CAPA effectiveness and follow up.

About this template

  • Versatile & easy to use risk assessment template
  • Immediate download
  • MS word, 48 pages ready to use risk assessment template
  • Based on the FMEA methodology
  • Clear instructions for use
  • Fits for FDA/Eu./ISO 13485/ISO 14971/HIPAA/GDPR regulations
  • Fit to Pharma/Medical/E-Health/Supplements and other industries

Your final Risk Assessment draft can be reviewed by our consultants- Optional

Benefits

Understand how our risk Assessment templates will support you best:

Best methodology and practice that fits your industry, products, and regulatory requirements

Have a template that is being used daily by our consultants in international FDA/CE/Eu audits

Improve your regulatory documents writing capabilities

Prepare your documents, based on smart & easy to use templates

Pass FDA/CE/Eu audits and submissions easily*

Immediate access to downloads

Be independent and keep professionalism in-house.

In Addition

Get access to hundreds of templates for your future needs

Get full support and advice for your regulatory needs

Customized documents writing

Review your final document before final approval

Bio-Chem is here to support all your current and future regulatory and documentation needs!

Buy our templates and join our returning clients

For Further Information Please contact us.

Reviews

There are no reviews yet.

Be the first to review “FMEA Risk Analysis document template”

צור קשר