Effective Date:
Procedure ID:
Rev:
DC
[Dept. or Organization]
Controlled Copy #:
Department(s):
Page 1 of 7
Procedure Title: Document Control System
SOP Approvals
Title
Name
Signature
Date
Technical Authority
Department Head
Quality Assurance
1.0
Purpose
1.1
2.0
3.0
This procedure describes the document control policies governing the routing,
tracking, distribution, reconciliation and control of the dept’s Standard Operating
Procedures (SOPs), their associated forms and labels, and other non-SOP
documents.
Scope
2.1
This procedure applies to all controlled documents used within the dept. that
pertain to the cellular collection and processing and therapeutic apheresis.
Document Control personnel under the direction of the Quality Assurance (QA)
manager is responsible for the maintenance of all controlled documents.
2.2
This procedure does not apply to documents used within the dept. that pertain to
preclinical or research cellular products.
2.3
Document Control personnel perform the steps in this procedure unless
otherwise specified.
Definitions
3.1
Archived Document: document retained by Document Control personnel that is
no longer in active use.
3.2
Controlled Binders: contain copies of approved documents. Controlled binders
are maintained for use by personnel and must be accessible when and where
procedures are performed.
3.3
Controlled Document: any document required by, but not limited to, current
regulations and standards to design, manufacture and control the production of
cellular products. Such documents have restricted capacity for modification and
controlled distribution for both hard copies and electronic versions. Controlled
documents include, but are not limited to, SOPs, Batch Production Records,
Policies, Plans, Protocols, Reports, Studies, Processing Worksheets, Forms and
Labels.
CONFIDENTIAL INFORMATION
Property of [Organization or Company Name]
Effective Date:
Controlled Copy #:
Procedure Title: Document Control System
Page 2 of 7
Document Control: established processes for creating, approving and changing
standardized documents.
3.5
Electronic Draft Folder: contains draft versions of SOPs and the Table of
Contents. The CCP staff is able to access this folder in order to create, revise or
review documents.
3.6
Electronic Effective Folder: contains current approved version that include, but
are not limited to, SOPs in PDF format. PDF versions of controlled documents
contain the watermark, “COPY.” All staff is able to access this folder in order to
view documents.
3.7
Electronic Master Folder: contains current approved versions that include, but
are not limited to SOPs, Reports and Forms, and Labels. Access to this folder is
restricted to designated QA personnel.
3.8
Master Document File (MDF): contains the original document and all approved
revisions and forms associated with a particular controlled document, if
applicable. Access to MDFs is restricted to QA and personnel with
responsibilities for document control.
3.9
Pending Approval File: contains draft versions of a restricted document during
the approval process. Access to this folder is restricted to designated personnel.
3.10
Portable Document Format (PDF): self-contained cross-platform document
created and viewed using Adobe Acrobat software.
Safety
Not Applicable
Materials and Equipment
5.1
5.2
5.3
5.4
6.0
Department(s):
3.4
4.1
5.0
Rev:
DC
[Dept. or Organization]
4.0
Procedure ID:
Computer with secure access on the network
File cabinets located in a controlled storage area
Software Program, Adobe Acrobat
Word Processing Program, Microsoft Word or equivalent
Procedure
6.1
Electronic File Maintenance of Controlled Documents
6.1.1
Upon receipt of an approved Document Initiation/Revision Form, place
either a document template for new documents or a copy of the most
CONFIDENTIAL INFORMATION
Property of [Organization or Company Name]
Effective Date:
Procedure ID:
Rev:
DC
[Dept. or Organization]
Controlled Copy #:
Procedure Title: Document Control System
Department(s):
Page 3 of 7
current version of the requested document in the appropriate Draft folder
on the shared network drive for accessibility by appropriate staff. Refer to
procedure, “Documentation Initiation, Revision and Approval,” DC.002 for
details and an example of the form.
6.1.2
For new documents, complete the header with the appropriate document
title, document ID, and department designation. Complete the effective
date field to reflect that the SOP is in draft and enter the revision number
as 00. Name the document to reflect that it is a draft version and include
the current date and the revision number (e.g., DC. REV 00 DRAFT
Document Control Systems 1, 12, 05).
6.1.3
For revisions of existing documents, change the effective date in the
header to reflect that the document is in draft and update the revision
number to reflect the next consecutive number (e.g., revision 00 become
revision 01). Rename the document to reflect that it is a draft version and
include the current date and the revision number (e.g., DC.003 REV 02
DRAFT Document Control System 1, 12, 05).
6.1.3.1 Protocols, Reports and Studies are considered one-time
documents and are not revised. Amendments may be included in
these documents, but this does not require a revision to the
document number.
6.1.4
When a document is undergoing a revision, continue to maintain the
original effective document within the electronic Master and Effective
folders.
6.1.5
Move completed and revised documents to the appropriate Pending
folder to prevent further alterations to the document while it is being
circulated for approval signatures. The electronic document retains the
“DRAFT” suffix until final approval and circulation of the Employee
Document Review Form, to the appropriate staff. Refer to procedure,
“Document Initiation, Revision and Approval,” DC.002 for details.
6.1.6
When an effective date has been assigned and the document is ready for
implementation, move the document from CCP Pending Approval folder
to the appropriate Master folder. Remove the “DRAFT” suffix from the
document title and update the date to reflect the effective date of the
document. Refer to procedure, “Documentation Initiation, Revision and
Approval,” DC.002 for details.
6.1.7
Create a PDF copy of the final, effective document containing the
watermark, “COPY” and place it in the appropriate electronic CCP
Effective folder.
CONFIDENTIAL INFORMATION
Property of [Organization or Company Name]
Effective Date:
Controlled Copy #:
Procedure Title: Document Control System
6.2
Rev:
DC
[Dept. or Organization]
6.1.8
Procedure ID:
Department(s):
Page 4 of 7
Delete previous versions of the document, if they exist, from both the
Master and Effective folders.
Master Document Files
6.2.1
Master Document Files are filed and indexed by Table of Contents
sections, document number, and revision level. They contain, at a
minimum, the following documents:
6.2.1.1 Completed Document Initiation and Review Form
6.2.1.2 Signed Employee Documentation Review Form
6.2.1.3 Original signed document
6.2.1.4 Completed Distribution/Reconciliation Records
6.3
Controlled Binders
6.3.1
Label binders consecutively beginning with #1. Maintain an index of the
location and contents of each binder.
6.3.2
Stamp the “Controlled Copy #” in the header of each copied document
and place it in the appropriate numbered binder.
6.3.3
When binders are updated, revise the Table of Contents and place the
printed document in the appropriate binder. Initial and date next to the
revision date printed in the footer of the Table of Contents. The table of
contents consists of a listing of all documents in the binder by document
number, revision number, document name, and the effective date. Verify
that copies of previous or archived versions of documents are returned to
Document Control for destruction. Document the distribution and
reconciliation of the procedure on the appropriate
Distribution/Reconciliation Record. See Appendix DC.003.01.
6.4 Controlled Document Distribution and Reconciliation
6.4.1
Distribute and reconcile controlled documents according to the following
steps:
6.4.1.1 SOPs: Copies contained in the Controlled Binders are distributed
and reconciled as described in Section 6.3.
6.4.1.2 Copies of controlled documents to be sent to an outside
institution: copy the document, stamp each page with “COPY”
and “CONFIDENTAL” and send the document to the requesting
individual or institution. For electronic copy requests, use
CONFIDENTIAL INFORMATION
Property of [Organization or Company Name]
Effective Date:
Procedure ID:
Rev:
DC
[Dept. or Organization]
Controlled Copy #:
Procedure Title: Document Control System
Department(s):
Page 5 of 7
Acrobat to create a secured PDF file of the document(s)
containing the watermark, “COPY” and send via email to the
individual(s) making the request.
6.4.2
Record all document distribution and reconciliation actions on the
Distribution/Reconciliation Record. File the completed
Distribution/Reconciliation Record in the appropriate MDF. See Appendix
DC.003.01.
6.4.3
Forms and processing worksheets are only kept in designated areas and
are managed by Document Control personnel.
6.4.4
Distribute forms, processing worksheets, batch production records and
reports templates according to the following steps:
6.4.4.1 Forms and worksheets associated with SOPs: distribute copies
upon request to the appropriate document control personnel.
When SOPs are revised, remove and destroy all associated
superceded forms and processing worksheets from office and
laboratory areas.
6.4.4.2 Reports associated with SOPs: report templates are maintained
in a separate Report/Form folder within the Master electronic file
folder. Distribute copies upon request to the appropriate
personnel.
6.4.4.3 Batch Production Records: distribute copies upon request to the
appropriate personnel.
6.4.5
Labels
6.4.5.1 Document Control distributes and reconciles all labels associated
with cellular collection, processing and therapeutic apheresis.
Refer to procedure, “Labeling Issuance and Control,” DC.004 for
details.
6.5 Archived Documents
6.5.1
Complete Section 1 of a Document Initiation, Revision and Approval Form
with the following information: Refer to procedure, “Document Initiation,
Revision and Approval,” DC.002 for details and an example of the form.
6.5.1.1 Originator Name
6.5.1.2 Document Type (e.g., SOP, Batch Production Record, Policy)
6.5.1.3 Document Title
CONFIDENTIAL INFORMATION
Property of [Organization or Company Name]
Effective Date:
Procedure ID:
Rev:
DC
[Dept. or Organization]
Controlled Copy #:
Procedure Title: Document Control System
Department(s):
Page 6 of 7
6.5.1.4 Document Number
6.5.1.5 Check “Archive”
6.5.1.6 Under Section, “Document Changes/Justification,” explain the
reason for archiving the document.
6.5.1.7 Originator (Signature/date)
6.6
6.5.2
Submit the completed Document Initiation and Review Form to the
appropriate Department Manager and the QA Manager, requesting their
approval for document archival.
6.5.3
File the approved Document Initiation and Review Form in the
appropriate MDF. Transfer the archived MDF to the Archived Section of
the file cabinet, separate from the Active MDFs.
6.5.4
Delete all previous electronic versions of the document, if they exist, from
both the electronic Master and Effective folders.
6.5.5
All original paper versions of archived documents are maintained
indefinitely.
QA Audits
6.6.1
7.0
Expected Results
7.1
8.0
9.0
The QA group performs audits of controlled binders and MDFs on a
periodic basis to ensure their accuracy and completeness.
All controlled documents used by the dept. are maintained, distributed, and
reconciled by Document Control personnel as described in the steps of this SOP.
References
8.1
Code of Federal Regulations (CFR) 21 CFR 211.100 and 21 CFR 1271.80.
8.2
Foundation for the Accreditation of Cellular Therapy Standards (FACT), C.5000
and D.5000, 2nd Edition, 2002.
8.3
SOP: DC.002, Document Initiation, Revision, and Approval
Appendices
9.1
DC.003.01: Distribution/Reconciliation Record
CONFIDENTIAL INFORMATION
Property of [Organization or Company Name]
Effective Date:
Controlled Cellular Production
Controlled Copy #:
Procedure ID:
Rev:
DC.003.01
04
Department(s):
ORIGINAL
Page 1 of 1
Procedure Title: Distribution/Reconciliation Record
Document Number:
Revision #
Effective Date:
Document Title:
Binders
External Documents
Controlled Copy #
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
Reconciled
DC Initials/Date
Paper Copy
PDF
DC Initials/Date
Distributed To Whom:
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
Reconciled
DC Initials/Date
Paper Copy
PDF
DC Initials/Date
Distributed To Whom:
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
Reconciled
DC Initials/Date
Paper Copy
PDF
DC Initials/Date
Distributed To Whom:
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
Reconciled
DC Initials/Date
Paper Copy
PDF
DC Initials/Date
Distributed To Whom:
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
DC Initials/Date
Reconciled
Paper Copy
PDF
Distributed To Whom:
DC Initials/Date
Distributed
Reconciled
DC Initials/Date
Paper Copy
PDF
DC Initials/Date
Distributed To Whom:
CONFIDENTIAL INFORMATION
Property of [Organization or Company Name]