Clarifying the rules and Provision for data analysis allows for standardization within the company.
By standardizing the rules, you will be able to respond smoothly to FDA inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K13 Data Analysis Provision
・MD-QMS-S1301 Data Analysis Procedure
・MD-QMS-F1301 Data Analysis Sheet

Table of Contents

Provision

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Data collection and analysis
4.1 collected data
4.2 Data Analysis
5 Analytical results Discussion
6 Reporting of Analysis Results
7 Record keeping
8 See and reference Documents
9 by-laws

Procedure

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Data collection and analysis
5.1 Data Collection
5.2 Data Analysis
5.3 Analytical results Discussion
5.4 Corrective and preventive measures origination
5.5 Reporting of Analysis Results
5.5.1 Report to Management Review
6 Record keeping
7 form
8 See and reference Documents
9 by-laws