Good Documentation Practices

Good Documentation Practices
HSGBU and OCI
Training Agenda
Introduction
The What, Why, and How
Objective Evidence
Challenges
Copyright 2013, Oracle and/or its affiliates. All rights reserved.
Confidential Oracle Internal
What?
What are the Good Documentation Practices?
Good Documentation Practices (GDP)

Good Documentation Practice (GDP) is a term the pharmaceutical
industry uses to describe:

standards by which documents are created and maintained. the required activities and steps to use when recording data and
other handwritten entries.

While not law, authorities will inspect against these guidelines in addition to the legal requirements and make comments or observations if departures are seen.
HSGBU Quality Management System Charter

QMS Charter Section 8 Document Management
QMS Ownership and Approvals
Document owners will confirm the consistency of the relevant documents with actual
implemented practice and will assign appropriate authors to draft updated versions. Document approvers will acknowledge the validity of the document contents for use by operational teams.
Creation and Control of QMS Documents

The process and procedures by which HSGBU documents are controlled along with
Good Documentation Practice (GDP) guidelines are covered in:

HSGBU.SOP.001 Quality Management System Document Management.
Why?
Why do we need Good Documentation?
Customer Expectations
ISO 27001 Certification

Meet Customer Requirements - advertise your quality certification
Improve Company and Product Quality - an improved level of quality
for the entire organization every process, and every product.

Increase Customer Satisfaction with your Products - Quality
means whatever you produce will work as your customers expect.

Achieve International Quality Recognition - Obtaining ISO
certification puts Oracle in a very select group.
ISO 27001: Documents and records may be in any form or type of medium.
4.3.2 Control of documents:
Documents required by the ISMS shall be protected and controlled.

a) approve documents for adequacy prior to issue; b) review and update documents as necessary and re-approve documents; c) ensure that changes and the current revision status of documents are
identified;
d) ensure that relevant versions of applicable documents are available at
points of use;
4.3.2 Control of documents:
e) ensure that documents remain legible and readily identifiable; f) ensure that documents are available to those who need them, and are
transferred, stored and ultimately disposed of in accordance with the procedures applicable to their classification;
g) ensure that documents of external origin are identified; h) ensure that the distribution of documents is controlled; i) prevent the unintended use of obsolete documents; and j) apply suitable identification to them if they are retained for any purpose.
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4.3.3 Control of records:
Records shall be protected and controlled. Records shall remain legible,
readily identifiable and retrievable.

The controls needed for the identification, storage, protection, retrieval,
retention time and disposition of records shall be documented and implemented.
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HSGBU.SOP.001
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HSGBU Quality Management System Documentation Management

Documents must be completed with indelible black or blue ink. No checkboxes, cells, or lines should be left blank in documents. Items not
applicable will be completed using N/A or by drawing a line through the cell.
Date formats for electronically entered or hand written dates must be captured
in an unambiguous format. e.g.: 19 Jan 2013. (Time is recorded in 24 format: 2pm = 14:00 )
Signatures:
All hand written or electronic/digital signatures will be accompanied by a date. Dates must be written at the time of a wet signature and must not be pre-printed on the
document.
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Examples
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HSGBU Quality Management System Documentation Management

Staff may not use any artificial correction materials such as white out or
correction tape or any other means of obliteration of any entries (except when performed to protect the confidentiality of a customer or patient).
Handwritten corrections will follow this procedure: cross one line through the
original data or statement, write in the correct information, initial and date the correction, and provide a brief reason for the cross out/correction. Do not completely obliterate the original record. It must remain readable.
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Example
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Example
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Example
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Example
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Example
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Example
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How
How To Do Good Documentation
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ALCOA
A GDP acronym used in the pharmaceutical industry:
Attributable - To relate to a particular cause or source (e.g.: your dated

signature or initials)
Legible can be easily read by others Contemporaneous documented at the time of occurrence Original Original Source Document. If not original should be exact copy; the
first record made by the appropriate person.
Accurate to the best of your ability, what you have documented is correct.
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What needs to be documented?

Anything needed for reconstruction and traceability.
Provide written or electronic records to authenticate the conduct of an
activity. Objective evidence that actions are being performed. Must be recorded at the time of occurrence. Should not require a verbal explanation or additional explanation, should describe what & when the activity was performed, the steps, actions, and outcomes, it should contain the signature / initials of those directly involved and the date that the actions were performed and the signature /initials were written.
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How should it be documented?

It is easy other key points to remember:
Be Truthful what has been documented is actually what
occurred Be Consistent documented in the same way each time Make It Secure safely stored, protected from deterioration, destruction, tampering, theft, and vandalism.
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There is no consequence for documenting too much, only too little.

26 Copyright 2013, Oracle and/or its affiliates. All rights reserved. Confidential Oracle Internal
Quality Control Checks
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Examples of Common Mistakes

Draft is noted on a final version.
Incorrect version numbers are listed. People listed as the reviewer are different from who actual signed.
Update the Table of Contents.

Do NOT pre-date or post date. Do not sign for something you didnt do.
Ensure any referenced documents and/or referenced section numbers
within the document are accurate.
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Applying GDPs to Your Daily Routine

What Will Help You Remember?

Use these references:
A copy of the slides for this training A GDP Cheat Sheet
Are both located on the A&C webpage:

http://my.oracle.com/site/hsgbu/lob/AuditandCompliance/Training/index.html
HSGBU.SOP.001 is located on the A&C webpage:
http://my.oracle.com/site/hsgbu/lob/AuditandCompliance/SOPsandWIs/SOPs/index.html?ssFolder=270737
Slow Down
Thoroughly read and review your document.
Second pair of eyes

Have a co-worker check your document.
Thank you!
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HSGBU and OCI

Copyright 2013, Oracle and/or its affiliates. All rights reserved.

Confidential Oracle Internal

Copyright 2013, Oracle and/or its affiliates. All rights reserved.

Confidential Oracle Internal