GOOD DOCUMENTATION

PRACTICE
GOOD DOCUMENTATION PRACTICE

• What is the definition of Good documentation

Practices (GDP)?
• Concise, Legible, Accurate and Traceable
records.
• This simple statement explains all the
requirements of GDP.
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Now we know the definition, but do we
understand it?
CONCISE : The document must tell the entire
story and be understood by internal/external
customers.
LEGIBLE : The document must be readable by
internal/external customers.
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• ACCURATE : The document must be error free.

• TRACEABLE : Each aspect of the document

must be traceable, such as who recorded it,
where and why.
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• Let’s examine what it means to be CONCISE.
Are our documents standardized?
Are the documents easy for all to use?
Do we have certain documents that
consistently have errors?
Do our documents tell a complete story: the
beginning, the middle and the end….to every
one?
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Once these questions are answered and

resolved you can begin a new understanding
of “concise”.
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• How do we make the task easy?
• Let’s examine what legible means.
• In it’s most simple form, legible means:
Can everyone read what is written?
No matter who, where or what, can the written
or printed data be ready by everyone?
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• Let’s examine what it means to be Accurate:

• Data shall be recorded as soon as possible and

shall not be falsified.
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• Let’s examine what Traceability means.
• Can everyone understand who recorded the
data, why it was recorded, what was recorded
and when it was recorded.
• Is everyone signing for what they recorded?
• Do we have a SOP that requires the record?
• Do we understand what is we are recording?
• Can we determine when it was recorded?
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• Why should I do this?
• Documents are objective evidence that
actions or tasks have been performed.

• Regulatory Agencies do not have code of

Federal Regulations (CFR) requirements saying
to do this. Why?
BECAUSE GDP IS AN EXPECTED PRACTICE…..
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Which Records?
Generally, it is a good practice to GDP all
records. There are no consequences for doing
to much, just doing to little.

However, Quality system records must always be

reviewed for GDP.
GOOD DOCUMENTATION PRACTICE
• What examples of Quality System Records are:
Purchase Orders
Contracts
Device History Records
Management Reviews
Training Records
Device History Files
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• Are there other types of Quality System

records?
• Absolutely ask your Quality management.
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• What am I responsible for?
• You are responsible for your signature:
Written signature
Should at a minimum be your first initial and full last
name.
K. Swami Nathan
Initials maybe used on any page of a document
once your signature appears on that page
KSN
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• You are responsible for your signature:
• Electronic signature
• It shall never be transmitted or disclosed to
anyone else.
• You should never use someone else’s
electronic signature.
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• What am I responsible for?
• You are responsible for all recorded
information before you……….

• WHAT ??????? WHY???????

Yes, you should be reviewing all data before you
to be sure no one has made any mistakes.
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• What do I do if I find a mistake?
• All errors should be corrected by the person
who created them.
• Or, if that person is not available, the error can
be corrected by their manager.
• Or, if that person is not available, the error can
be corrected by the next highest member of the
management.
and so on and so on …..etc,
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• How are mistakes Corrected?
• Four simple steps:
• Draw a single line through the error.
• Make the correction next to the error.
• Write an explanation for the error.
• Sign and date the correction.
GOOD DOCUMENTATION PRACTICE
• What to do if you don/t have enough space
for the correction, explanation and/or
signature and date.

Simple enough: Draw an asterisk (*) next to

the error. Place the asterisk (*) on the same
page where there is place to write. Now put
your information there.
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• Is that all I need to know?
• Well this would depend on your standard
operating procedure (SOP).
• Likely no, there should be more.
• Do you have written SOP’s?
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• Ok, when in doubt what do I do?
• Ask, ask, Ask – I can not stress this enough.
Ask your manager, quality or a company auditor.
You are really responsible for documents you
sign.
Remember, if you let an GDP error go, it will be
worse later.
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• Different types of documents and records.
• Batch Record forms
• Bill of materials
• Specifications
• Policies
• Protocols
• Standard operating procedures
• Work Instructions
• Test methods
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• Check lists
• Forms/log sheets
• Training Assesments
• Electronic and hard copy Quality records.
• Certificate of analysis
• Technical transfer reports
• Validation documentation.
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• Clearly written documentation:
• All documents must be accurate and written in
a manner that prevents errors and ensures
consistency. If documents are to be used
together, e.g. an SOP and a form, then each
should reference the other.
• Ensure there is traceability between two or
more documents/records using formal
document numbers or record identification.
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• Using indelible ink:

• All records must be filled out in indelible ink
for long term legibility. Do not use pencil or
ink that can be erased.
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• Legible hand written entries:
• A document is unusable if it can’t be read, so
care must be taken to ensure that handwriting
is legible. All entries must be made at the time
the tasks are performed and should be legibly
signed and dated.
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Reviewing and Approving:
Documents and records should be reviewed by
someone who did not perform the task to ensure
that the information is correct and accurate. A
signature and date by the reviewer/approver
confirms that a review has taken place.
Unsigned documents or records are incomplete
and should not be used to perform any task or
considered as evidence of completed task.
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• Staff Signatures :
• Handwritten signatures must be unique to the
individual and listed within the site signature
register to ensure that the signature is
traceable to a member of staff.
• Staff are not permitted to sign for another
member of staff unless delegated.
• Signatures must never be forged.
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• Signed delegation of responsibility:
• In the event that a critical member of staff is
absent for a time, they must delegate
responsibility to another qualified person. The
delegation must be either :
Proceduralized in a document (SOP, WI etc) or
Documented with names of all people involved
and signed by the person that is delegating
their responsibility.
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• Page Numbering :
• GMP documents should have page numbers
using the following standard “X of Y” to
indicate the total number of pages in a
document.
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