This is a collection of Provision, Procedure, and Forms for document management in a form consistent with the FDA QSR.
With the increasing complexity of document management methods such as digitization of documents, etc,
Document management has come to be strictly required.
List of Forms
The following forms are included with your purchase.
・MD-QMS-K2 Document Management Provision
・MD-QMS-S201 Document Management Procedure
・MD-QMS-F201 Application for Revision and Abolition of the Documentation System
・MD-QMS-F202 Document List
・MD-QMS-F203 Document Periodic Verification Record
・MD-QMS-F204 List of obsolete documents
・MD-QMS-F205 List of external documents
・MD-QMS-F206 Document Template
・MD-QMS-F207 Form Template
・MD-QMS-F208 Deliverable Description Document Template
Table of Contents
Provision
1 Objective.
2 scope (of a document)
3 Definition of Terms
4 QMS Documentation System
5 superintendent supervisor of document management
6 QMS Documentation Management
6.1 Principles of QMS Document Management
6.2 QMS documentation
6.3 Identification of QMS documents by document number
6.4 Review and approval of QMS documentation
6.5 Education on QMS documentation
6.6 Disclosure of QMS documentation
6.6.1 Disclosure of documents in the case of paper originals
6.7 List of QMS Documents
6.8 Management of output QMS documents (paper media)
6.9 Identification of controlled and uncontrolled documents
6.1 Periodic review of QMS documents
6.11 Revision of QMS documentation
6.12 Elimination of QMS documentation
6.13 Handling of out-of-date documents
6.14 Management of procedures and other documentation specific to equipment
6.15 Document Retention
6.15.1 Storage method
6.15.2 retention period
7 Records Management
7.1 Principles of Records Management
7.2 Creation of records
7.3 Approval of records
7.4 Version control of records
7.5 Correction of records
7.6 Identification of records
7.7 Access to and viewing of records
7.8 Record keeping
7.8.1 Storage method
7.8.2 retention period
8 External Document Management
9 Compliance with regulatory requirements for managing documents in electronic media
10 reference
11 supplementary provisions
Procedure
1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 QMS Documentation Management
5.1 Application for establishment or revision of QMS documentation
5.2 QMS documentation created/revised/reviewed/approved
5.3 Management of original documents
5.4 Education on QMS document revision
5.5 Disclosure of QMS documentation
5.5.1 For electronic original documents
5.5.2 For original paper documents
5.6 Periodic review of QMS documentation
5.7 Elimination of QMS documentation
5.8 External Document Management
5.9 Document output and copying
5.1 Disposal of QMS documents
6 management of records
6.1 Creation of records
6.1.1 Creation of records in electronic media
6.2 Correction of records
6.3 Record keeping and protection
6.3.1 Paper storage and protection
6.3.2 Storage and protection by electronic media
6.4 Storage of DMR and DHF
6.5 Disposal of records
7 Taking out and copying QMS documents and records
7.1 Browsing and taking out
7.2 Photocopying of documents and records
7.2.1 When photocopied materials are used for educational purposes
7.2.2 When submitting a photocopy of a document outside the company
8 form
9 reference
10 by-laws