Standard Operating Procedure Confidential

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APPROVAL BLOCK

APPROVALS TITLE SIGNATURE/DATE

Prepared By:

Reviewed By:

Approved By:

1. PURPOSE

This procedure describes the activities necessary to control and file cGMP
documents used and generated at the InstantGMP™ Manufacturing Site.

2. SCOPE

This procedure applies to electronic and hard copy cGMP documents at the
InstantGMP™ Manufacturing Site. It applies to all personnel assigned to
work in the InstantGMP™ Manufacturing Site.

Sponsors, vendors and manufacturers are responsible for complying with this
SOP when an instance of InstantGMP™ is used for manufacturing, except
that Sponsors, vendors or manufacturers may use their document
management system if available. Responsibilities will be defined in a Quality
Agreement.
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3. REPONSIBILITIES

3.1. The Quality Manager is responsible to assure this procedure is followed,

remains consistent with current practices and is reviewed and updated
as necessary.

4. REFERENCES

4.1. POL-0500 – Document Storage Policy

4.2. SOP-0104 – Change Control

4.3. SOP-0221 – Documentation Practices

5. BUSINESS REQUIREMENTS

5.1. Official copies of all documents will be electronic copies. Paper copies
will be dated at the time of printing and expire one month later.

5.2. Controlled Documents are defined as those documents that fall under
the Change Control system.

6. PROCEDURE

Responsible Party Action Step

Controlled Documents and Forms (SOP, MPR, Policies,
Clinical Shipping Forms)
User 1. If a hard copy of an executed form or document is
required:
a. Print from the appropriate Master file.
b. Stamp as “COPY”.
c. Initial and date.
NOTE: the copy is only good for one month.

2. If creating a new controlled document follow the

appropriate SOP.
3. If revising a controlled document:
a. Make a copy from the Working Copy folder and
revise according to SOP-0104, Change Control
and the appropriate SOP.
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Responsible Party Action Step

4. Place the final reviewed version in the electronic
Final Revision folder Notify the Document Manager
that the document is in the Final Revision folder.
Project Manager 5. When a controlled document has been placed in the
Final Revision folder:
a. Designate as “read only”.
b. Compare the new electronic version with the
previous version (if not new) and ensure that the
changes correspond to the appropriate approved
change control form. Ensure that any changes
are documented in the change history.
c. Ensure that new documents correspond to the
approved new document form.
d. If a form or guide is included in the original
document, create an identical interactive form/
guide locking the information on the form where it
cannot be changed.
6. When the document has been checked and is ready
for signatures
a. Assign an effective date as indicated by Quality
Manager.
b. Convert the Word Document to a PDF file.
c. Move the PDF file and any interactive
form/guides to the Signature folder.
Quality Manager 7. Ensure that the form/guide in the form/guide folder
corresponds to the form/guide in the document.
8. Sign and date the approval page approving both the
form/guide and the SOP document.
Project Manager 9. When approval signatures are on the document:
a. Move any forms/guides to the SOP - Finals
Folder within the SOP folder and then file per
POL-0500, Document Storage Policy.
b. Ensure that only the effective version is available
for use. Place the superseded version in the
Archive folder.
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Maintaining Logs

Project Manager 10. Create logs in the appropriate vault in Master

Control.
11. When a number is requested, ensure that the
number given is the next in sequence.
Filing Executed Documents and ancillary information
Project Manager 12. Scan document into PDF file and place in
appropriate “read only” file using Attachment II as a
guide. In general, file documents specific to a part
number, Equipment, number or room number in the
folders with those numbers. If document applies to
more than one part#, equipment #, or room #, file in
specific SOP # folders. Equipment and Facility
Manuals should be filed according to S405
Equipment Receipt and System Manuals.
NOTE: If a Study is blinded, do not open sealed
envelopes before filing.

Filing Quality Agreements

13. File Quality Agreements in accordance with the site’s

document storage policy.
Filing Training Records

14. File Training Records in accordance with the site’s

document storage policy.
Filing Regulatory or Client Inspection Reports

15. File Inspection Reports in accordance with the site’s

document storage policy.
Filing Deviation Reports

16. File Deviation Reports in accordance with the site’s

document storage policy.
Filing Document Review Forms
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17. File Document Review Forms in accordance with the

site’s document storage policy.
Filing Batch Specific Information

18. File Batch Information that is not electronically stored

in an instance of InstantGMP in accordance with the
site’s document storage policy.
Filing Part Number Specific Information

19. File Part Number specific Information that is not

electronically stored in an instance of InstantGMP in
accordance with the site’s document storage policy.

7. DEFINITIONS/ACRONYMS

N/A

8. FORMS

8.1. Attachment I: Flow Chart for Controlled Documents

8.2. Attachment II: Filing Guide

VERSION HISTORY

EFFECTIVE
VERSION DESCRIPTION OF CHANGE
DATE
00 New SOP.
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Attachment I: Flow Chart for Controlled Documents

KEY:
Working Copy
USER
Start Folder DOC MANAGER
QUALITY MANAGER

New
Is document to be
changed
or
created?

Changed
Create document

Make Electronic
Copy from Working
Copy and revise

Move Signature
Final Revision Folder document to
Folder Working Copy
(read-only) Folder

Compare document Scan document &

to new/change forms/guides into
control forms Master Folder

Create forms/guides
from attachments
Stamp Effective Date
and update forms/
guides page

Document &
forms/guides Print document
Signature Folder Ensure form/guides
&
(read-only) correspond
sign
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Attachment II: Filing Guide

Master File (Level 1) (Level 2)

SOP Table of Contents
Individual SOP
Master
Working Copy
Final Revision
Information specific to
each SOP
Signature SOP’s
Policy’s
Specifications
Logs CAPA Log
Change Control Log
Deviation/Inspection Log
SAE Log
Policies Table of Contents
Individual Policies Master
Working Copy
Final Revision
Part # Specifications Master
Working Copy
Final Revision
MPR Master
Working Copy
Final Revision
Vendor Qualification
Receiv./ Batch Number C of A/ C of C
Test/ inspection results
Shipping info
Material request info
Inventory control &rec.
Disposition
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Master File (Level 1) (Level 2)

Equipment # Protocols
Work order/calibration
documents
Room # Protocols
Work order/calibration
documents
Project # Project related info