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Standard Operating Procedure

Title: Notebook Policy


Document Number: SOP-0001 Rev A
Effective Date: Page: 1 of 9

. Confidential & Proprietary Print Date: 7/14/2014 12:21 PM
1. PURPOSE
This document describes the procedures for managing and maintaining notebooks.
Maintenance of a notebook is important for the following reasons:

1.1 Recording Information

1.1.1 The notebook represents the initial location where information regarding
research and development is recorded for reference. Notebooks are therefore
essential to the reproduction of experiments and the preparation of scientific,
legal, regulatory and quality manuscripts.
1.1.2 Notebooks also provide continuity between employees, permitting work to
continue even in the absence of the original researcher.
1.2 Protecting Intellectual Property

1.2.1 Notebook entries are legal records for establishing the date of and person(s)
responsible for an invention. This may prove important in competitive areas of
research.

1.3 Conforming to Regulatory Protocols

1.3.1 The notebook constitutes a part of the product design history, which must be
compiled to meet certain regulatory requirements.
1.3.2 Notebooks provide a ready reference to the raw data for others interested in the
researchers work. Notebooks are the primary records, which may be referenced
during internal or regulatory audits.
2. SCOPE
This policy applies to all personnel engaged in research, development and laboratory work.
3. REFERENCE DOCUMENTS
SOP-XXXXX Quality Management System Manual
SOP-XXXXX Record Retention Policy
N/A Notebook Log
4. RESPONSIBILITIES
4.1 All individuals performing research, development and laboratory work are responsible
for the following:
Ensure safe and secure storage of notebooks



Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 2 of 9

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Maintain custody of notebooks
Witness notebooks
Maintain accurate, complete, and current records of their work in notebooks
Adherence to this procedure

4.2 Supervisors are responsible for the following:
Ensure employees are trained and current against this procedure
Assure notebooks are appropriately maintained, signed, witnessed and returned
Final review and approval of notebooks
Close out outstanding notebooks of departing employees.
4.3 Document Control is responsible for the following:
Monitor and track notebooks issued, returned and archived
Secure and archive notebooks in Document Control

4.4 Quality Assurance
Periodic auditing of notebooks
5. DEFINITIONS
Term Definition
Researcher
The employee to whom a notebook is issued irrespective of
department.
Witness
An employee who is capable of testifying in court and technically
qualified to understand the significance of all notebooks entries. The
witness must not be a co-inventor or working on the same project.
6. GENERAL POLICY
6.1 All research, development and laboratory personnel must use a company-authorized
notebook.
6.2 Notebooks are the sole and proprietary property of the Company and must be
surrendered upon demand by an authorized Officer of the Company. They must be
returned to the Company upon termination of employment.
6.3 Notebooks, copies of notebooks or copies of pages from notebooks may not be
removed from Company premises without the written consent of the Chief
Technology Officer (CTO) or Chief Scientific Officer (CSO).




Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 3 of 9

. Confidential & Proprietary Print Date: 7/14/2014 12:21 PM
7. PROCEDURE
7.1 Obtaining New Notebooks
7.1.1 New notebooks can be obtained from the Document Control. If possible,
return each notebook on a given project at the time of checking out a new
one for that same project.
7.2 Notebook Handling
7.2.1 Handle and store notebooks safely to minimize the chances of loss or theft
(e.g., lock notebooks in a cabinet or drawer so they are out of sight).
7.3 Title Page
7.3.1 When starting a new notebook, complete the notebooks title page, including
notebook number, the name of the person to whom the notebook is issued,
the date of issuance, and the department. Enter the date of return upon
submission of the notebook for archiving.
7.4 Table of Contents
7.4.1 Fill in the table of contents in a systematic way that permits ready location of
information (e.g., a column each for the date, project number, subject and
page number). The table of contents must be complete when the notebook is
turned in for archiving. It may be useful to include a table of abbreviations
and symbols.
7.5 Notebook Entries
7.5.1 Date every entry, and sign at the bottom of the page when the page is
complete. All notebook entries must be recorded using permanent or
indelible ink, preferably black ink. Do not use pencil. Use legible
handwriting, with unambiguous numbers and symbols.
7.6 Notebook corrections
7.6.1 Make all corrections by drawing a single line through the cancelled entry.
Initial and date the correction. Write the corrected entry immediately next to
the cancelled entry. Never use liquid paper or otherwise attempt to erase,
overwrite or conceal an entry. If the reason for the correction is not obvious,
a written explanation must accompany that correction.
7.7 Consecutive pages
7.7.1 Use pages consecutively and make entries in chronological order.





Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 4 of 9

. Confidential & Proprietary Print Date: 7/14/2014 12:21 PM
7.8 Referencing Non-sequential Entries
7.8.1 Reference non-sequential entries in the table of contents and cross-reference
them to other relevant notebook pates. If the writing is a continuation of
work recorded on previous pages, precede the entry by filling in the notation
from page No.___. When work is suspended but continued on subsequent
pages, fill in the notation to page No.___
7.9 Attachments and Inserts
7.9.1 Because notebooks may be microfilmed and photocopied, it is essential to fix
data and other items with no overlap of material. Attach photographs,
instrument printouts, graphs, etc, individually to a notebook page without
covering any other entries on the page. Attachments and insert materials must
be fastened securely into the notebook using permanent acid free tape
avoiding direct contact with the printed image. Sign and date all attachments
by writing across the edge and onto the notebook page to which it is attached.
If attachments are photocopied reductions the final font size shall be no
smaller than 8 pt Times New Roman. If data are collected separately, proper
reference to that collection must be recorded in the notebook
7.10 Blank Pages
7.10.1 Draw a line diagonally across any blank pages between notebook entries and
sign and date the line prior to witnessing. The same applies to any unused
portions on notebook pages.
7.11 Identifying the Last Page
7.11.1 Identify the last used page of a notebook by drawing a line across the
following blank page and adding a written statement, signed and dated that
no further entries will be made on such notebook.
7.12 Entries Made after Witnessing
7.12.1 Avoid making entries to notebook pages after they have been witnessed. Any
changes or additions must be signed and dated by both the person making
the entry and the witness.
7.13 Noting Breaks in Work
7.13.1 When applicable, enter a note indicating that work has been carried out on a
continuous basis will be stopped for a period of time (e.g., going on
vacation, waiting for samples or instruments parts to arrive, etc.)





Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 5 of 9

. Confidential & Proprietary Print Date: 7/14/2014 12:21 PM
7.14 Keeping Several Notebooks
7.14.1 Separate notebooks for recording work from different projects with affiliated
companies may be maintained to facilitate retrieval of primary records.
7.15 Notebook Check Out
7.15.1 Notebooks are obtained from the Document Control.
7.15.2 Using the Notebook Log, Document Control records the name of the
individual checking out the notebook, the issue date and the notebook
number.
7.15.3 The individual checking out the notebook must sign the Notebook to confirm
receipt of the notebook.
7.16 Data Entry Checklist
Notebooks shall contain the following information:
7.16.1 Title
The title appears on every page. It should succinctly identify the nature of the
experiment. For easy referencing, it should identify the project.
7.16.2 Purpose of the Experiment
The purpose relates the title to the overall objective of the experiment. Some
purposes will be self-evident but others will reflect substantial planning,
involving considerations of why this experiment is done, why it is done at
this time, how it relates to other experiments e.g. expiration date.
7.16.3 Sample Information
Indicate the substance that is the focus of the experiment. When appropriate
list relevant physical and chemical properties (e.g. solubility, UV sensitivity,
etc.). Report on its source, previous storage conditions, and current
experimental handling conditions. List any materials used to prepare,
manufacture, test the sample. Record all lot numbers of materials as well as
any unusual or important information related to the materials or equipment.
7.16.4 Cross Reference
Identify all sources of information used in the present experiment. Provide
specific reference to SOP, research report, notebook #, complete literature
reference, etc.
7.16.5 Experimentation
The notebook should provide sufficient information to enable a co-worker to
duplicate the procedure and results. Cite the notebooks reference pages



Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 6 of 9

. Confidential & Proprietary Print Date: 7/14/2014 12:21 PM
when appropriate. Any changes, discrepancies, deviations to the procedure or
methods and their resolution must be recorded.
7.16.6 Quality Assurance Information
Record all pertinent information to assure the observance of good notebook
practices.
7.16.7 Experimental Results
Record all data and calculations including formulas, dilution schemes, etc.
into the notebook. Use appropriate units for all measurements. When
presenting graphs, put labels, tick marks and dimensions on the axis. Leave
any interpretation of the observations and results for later.
7.16.8 Data Evaluation/Conclusions
Provide information on the integrity of the experimental results, e.g. pass/fail
information when performing a test against specifications. Any comments on
the data/results should be reserved for this section and not be mixed with the
information recorded in previous sections. It is desirable that the conclusions
be connected to the initial purpose of the experiment.
7.16.9 Recording of Ideas
Ideas, thoughts, hypotheses, etc. not directly related to a specific experiment
must be recorded separately. These must be signed, dated, and witnessed.
7.16.10 Completed Header and Invention Sign Off
Top of Page:
Book No. ____________
Title: __________________________ Project No. ______________
Continued from page No. ____________

Bottom of Page:
Continued to Page No. ____________
Signature _____________________________ Date
Disclosed and Understood by __________________ Date __________

Disclosed and understood by is signed and dated according to witnessing
section below.






Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 7 of 9

. Confidential & Proprietary Print Date: 7/14/2014 12:21 PM
7.17 Signing
7.17.1 The researcher signs and dates each page of the notebook in the appropriate
field at the time and on the day the page was filled, remembering to mark and
initialize any blank spaces.
7.17.2 The signature must be legally valid. Using marks such as an 'X' are not
allowed.
7.18 Witnessing
7.18.1 Notebook entries are to be witnessed at least monthly by another company
employee.
7.18.2 The witness reviews each page before penning his/her signature. The
countersignature must be legally valid. Using marks such as an 'X' are not
allowed.
7.18.3 The accuracy of calculations must be spot-checked by a peer prior to
witnessing. This calculation check must be recorded on the page by writing
verified by followed by the persons signature and date.
7.18.4 The witness must understand the subject of the pages being witnessed and
must review all entries for completeness and clarity. The notebook may be
returned to the owner for additions and/or clarification (e.g. expanded
explanations or descriptions) and should be subsequently re-witnessed.
7.18.5 Every page of a notebook must be signed by the researcher and witnessed,
including any blank pages (cancelled by a diagonal line) between notebook
entries.
7.18.6 Unused pages at the end of a notebook need not be witness or signed.
7.19 Check In
7.19.1 The Document Control records a check-in event on the Notebook Log.
7.19.2 The date on which the notebook is returned and the Document Control's
signature is recorded to confirm return of the notebook.
7.20 Filing and Archiving
7.20.1 R&D Personnel may keep the most current notebook at his/her desk or
bench.
7.20.2 All bound notebooks will be collected and archived on an annual basis:



Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 8 of 9

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Notebooks that are older than 1 year (from the date of issuance) and/or
contain more than 10 pages of information will be closed to further entries
and collected. New notebooks will be issued at the time of collection.
7.20.3 Notebooks are considered quality records and are archived. When notebooks
are submitted for archiving, QA examines them to assure completeness. Any
deficiencies will be noted; and the notebook will be returned for correction
prior to archiving.
7.20.4 Notebooks are stored in Document Control.
7.20.5 Archived notebooks may be reviewed. Temporary removal from Document
Control is allowed by signing the Check-Out Log. Logbooks shall be
returned immediately after completing their use.
8. RECORDS
All logbooks are considered source documents and will be retained by Document Control in
accordance with the Document Retention policy.
9. END





Standard Operating Procedure
Title: Notebook Policy
Document Number: SOP-0001 Rev A
Effective Date: Page: 9 of 9

. Confidential & Proprietary Print Date: 7/14/2014 12:21 PM
10. HISTORY

Revision

Originator

Date Effective

DCO No.

Nature of Change
A J. Documar 10/11/14 0001 Initial Release