Quality & Compliance

In FDA-regulated Industries
Good Documentation
Practices
 Good Documentation Practice
• What are they?
• Standards by which documents are created and
maintained.
• Not codified by FDA, but are considered cGMP.
• While not law:
• Authorities will inspect against these guidelines
and cGMP expectations.
• Make observations if not in place.
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 Good Documentation Practice
• Why are they needed?

• To standardize the
documentation practices
throughout the industry.

• To increase and assure

the accuracy, quality and
integrity of data, documents
and records.
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 Good Documentation Practice
• Who needs to implement them?

• EVERYONE! Cleaning Logs

Training
Records

• ALL POSITIONS!

Correspondence
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 Good Documentation Practice

• What are the standards?

• Creation of New Documents
• Review and Approval of Documents
• Completion of Documents - Data Entry
• Reproduction of Documents - Copying
• Maintenance of Documents
• Modification of Documents - Change

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 Good Documentation Practice
• What are the standards?
• Creation of New Documents:
• Contemporaneous (Timely)
• Typed (Not Handwritten)
• Checked for Accuracy (Error-free)
• Formatted for Trend Evaluation
• Adequate space for data entries
• For SOPs, include:
• Process Flow Diagram
• RACI Matrix (Responsible, Accountable, Consulted, Informed)6
 Good Documentation Practice
An Event occurs.

• Process Flow Diagram –

For Critical and Major Quality Events,
QA initially classifies Quality For Minor Quality Events, QA periodically
QA alerts IRB Chairperson or delegate
Event as Critical, Major or Minor. provides the IRB with a summary / update.
that an IRB Meeting is necessary.

Quality Event Investigation commences.

Example
If any preliminary Quality Event-related
information is available, the IRB
Chairperson or delegate distributes it to
Investigation Team identifies root cause(s).
the IRB for review prior to the IRB

Investigation Team identifies corrective and

preventive measures as a path forward.

Lead Investigator drafts QIIR .

IRB Chairperson convenes an IRB Meeting to

review the Quality Event and QIIR, including
a presentation by the Lead Investigator.

Does QIIR
No
meet IRB's
established
criteria?

Yes
QA and IRB approve QIIR and the QA dispositions Product / Material.
Lead Investigator revises QIIR
corrective and preventive
to address IRB's input.
measure(s) for release.
IRB Chairperson or delegate updates IRB Meeting
Log and prepares IRB Meeting Minutes.
Investigation Team formalizes corrective and
preventive measure(s) into CAPA(s) / PPCN(s) by
initiating CAPA / PPCN QETS records. IRB Chairperson or delegate saves IRB
Meeting Log and IRB Meeting
Minutes to I:\\Shared\IRB Folder.
QA approves CAPA(s) / PPCN(s).

No
CAPA(s) are implemented. PPCN(s) are implemented. QA closes PPCN(s) in QETS.
Phase 6 - CAPA Effectiveness Check

If QA determines that a CAPA Effectiveness Check is necessary,

then CAPA Owner opens an Effectiveness Check CAPA.

CAPA Owner and Team execute

the CAPA Effectiveness Check.

CAPA Owner and QA close Compliance periodically reviews and reports the
Effectiveness Check CAPA in QETS. results of CAPA Effectiveness Checks to the IRB.

Note: The Process Flow Diagram above has been simplified to focus on the Quality Event Investigation activities that involve Company's IRB. 7
 Good Documentation Practice
• RACI Matrix - Example Participating Parties (R = Responsible; A = Accountable; C = Consulted; I = Informed)
IRB IRB Quality Primary Lead Investigation
Chairperson Members & Assurance Responsible Investigator Team
& Co-chair Delegates (QA) Group (PRG) - Members
Event Owner
QUALITY EVENT INVESTIGATION PROCESS PHASES AND STEPS (SOP #14-001-216)
Ba s ed on i nforma ti on deta i l ed i n the Ba s i c Event Profi l e Form, cl a s s i fy Qua l i ty Event i ni ti a l l y a s Cri ti ca l , Ma jor or Mi nor. I I A R C I
Al ert IRB Cha i rpers on or del ega te tha t a n IRB Meeti ng i s neces s a ry (for Cri ti ca l a nd Ma jor Qua l i ty Events onl y). I A I I
Provi de dra ft i nves ti ga ti on reports a nd other ma teri a l s i n s upport of thei r pres enta ti on to the IRB pri or to s chedul i ng a meeti ng. R I C C A R
Communi ca te i nves ti ga ti on s ta tus a nd fi ndi ngs to Inves ti ga ti on Revi ew Boa rd (IRB) (for Cri ti ca l a nd Ma jor Events onl y) a nd ma na gement. I I R R A R
Revi ew QIIR, i ncl udi ng correcti ve a nd preventi ve mea s ure(s ). A R R R R
Meet es ta bl i s hed IRB cri teri a under Pha s e 5. C C R C A R
Approve QIIR a nd the correcti ve a nd preventi ve mea s ure(s ) for rel ea s e. R R A R R I
SPECIFIC
Schedul e IRB Meeti ngs (Sta nda rd a nd Emergency), a s needed. A I R I I I
Di s tri bute rel a ted ma teri a l s a nd i nforma ti on to the IRB. R I C C A
Revi ew the di s tri buted rel a ted ma teri a l s a nd i nforma ti on i n prepa ra ti on for the IRB Meeti ng. A R R R A R
Appoi nt a n IRB Del ega te from thei r depa rtment i f IRB Member ca nnot a ttend a n IRB Meeti ng. R A R R R
Lea d IRB Meeti ng. A R
Attend IRB Meeti ng. A R R R R R
Provi de overs i ght to i nves ti ga ti ons for i nterna l a nd externa l ma nufa cturi ng opera ti ons . A R R R R I
Enga ge i n the revi ew of i nves ti ga ti ons a nd provi de i nput towa rds ens uri ng a l i gnment of the i nves ti ga ti on wi th Regul a tory, Compl i a nce a nd Qua l i ty A R R R I I
expecta
Serve a stiaons .
forum for cros s -functi ona l depa rtment communi ca ti on rega rdi ng i nves ti ga ti ona l a cti vi ti es a nd trends . A R R R I I
Di s cus s s i gni fi ca nt i s s ues tha t ma y a ffect i nves ti ga ti ons . A R R R R R
Revi ew a ny open IRB a cti on i tems from previ ous meeti ngs . A R R R I
Ta ke meeti ng notes a nd then prepa re mi nutes of the IRB Meeti ng. A R
Pl a ce IRB Meeti ng Mi nutes i n IRB Sha red Fol der on Compa ny's I:\\ Dri ve for a cces s i bi l i ty by IRB Members et a l . A R
Ma i nta i n el ectroni c entri es i n the IRB Meeti ng Log. A R
Act a s the owner of the IRB Sha red Fol der on Compa ny's I:\\ Dri ve, a nd ens ure tha t a l l IRB members ha ve rea d/wri te a cces s to tha t fol der. A R
Ma i nta i n IRB Member - Del ega te Tel ephone Number Ma tri x. A R
Peri odi ca l l y pres ent Qua l i ty Event / QIIR / PPCN / CAPA Sta tus Upda tes to IRB. I I A I
Prepa re IRB Metri cs for pres enta ti on to other Compa ny Groups /Commi ttees /Boa rds . A R R I I I
Revi ew i nves ti ga ti on trends a nd recommend a cti ons to the MOC. A R R I
Peri odi ca l l y pres ent Qua l i ty Event / QIIR / PPCN / CAPA Sta tus Upda tes to Lea d Inves ti ga tors a nd Inves ti ga ti on Tea m Members . A R R I I I
Provi de ongoi ng revi ew of tra i ni ng a cti vi ti es for a nd qua l i fi ca ti ons of Lea d Inves ti ga tors . A R R C C I
GENERAL
Ens ure a l i gnment of thi s SOP wi th a ppl i ca bl e Regul a tory Gui da nce Documents . A C R
Ens ure a l i gnment of thi s SOP wi th a ppl i ca bl e Indus try Sta nda rds a nd Pra cti ces . A C R
Ens ure a l i gnment of thi s SOP wi th a ppl i ca bl e Compa ny Pol i ci es a nd Procedures . A C R C
Impl ement a nd ma i nta i n Good Documenta ti on Pra cti ces . A R R R R R
Tra i ni ng s peci fi c to thi s SOP. A C R I I I
RACI DEFINITIONS
Responsible
Thos e who do the work to a chi eve the ta s k. There i s typi ca l l y one rol e wi th a pa rti ci pa ti on type of res pons i bl e, a l though others ca n be del ega ted to a s s i s t i n the work requi red.
Accountable
The one ul ti ma tel y a ns wera bl e for the correct a nd thorough compl eti on of the del i vera bl e or ta s k, a nd the one who del ega tes work to thos e Res pons i bl e. In other words , a n Accounta bl e mus t s i gn off (a pprove) on work tha t a
Res pons i bl e provi des . There mus t be onl y one Accounta bl e s peci fi ed for ea ch ta s k or del i vera bl e.
Consulted
Thos e whos e opi ni ons a re s ought, typi ca l l y s ubject ma tter experts ; a nd wi th whom there i s two-wa y communi ca ti on.
Informed
Thos e who a re kept up-to-da te on progres s , often onl y on compl eti on of the ta s k or del i vera bl e; a nd wi th whom there i s jus t one-wa y communi ca ti on. 8
 Good Documentation Practice
• What are the standards?
• Review and Approval of Documents
• Reviewed by appropriate and authorized personnel
• Approved by appropriate and authorized personnel
• Signed
• Dated

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 Good Documentation Practice
• What are the standards?
• Completion of Documents - Data Entry – The Dos)
• Make entries in permanent/indelible Ink (NOT RED)
• Make entries Concise, Accurate and Legible
• Enter data in English (unless otherwise directed)
• For Critical Entries, have a second authorized person
independently verify activity/entry
• Number the pages to be added:
• Actual Page # followed by Total Page #
• Follow company’s format for Date and Time:
• Format cannot have numerous different meanings
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 Good Documentation Practice
• What are the standards?
• Completion of Documents - Data Entry – The Dos)
• Follow company’s format for Initials and Signatures
• Signatures and initials are serve as an employee’s
confirmation that the activity performed was per
the appropriate SOP or Work Instruction.
• Signatures and initials have
company-specific, legal, and/or
ethical ramifications.

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 Good Documentation Practice
• What are the standards?
• Completion of Documents - Data Entry – The Dos)
• For incorrect data entries:
• Use a single line-out
• Leave original date/entry legible
• Sign or initial
• Date
• At the time that the correction is made
• Include justification of the correction
• Concise and Accurate

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 Good Documentation Practice
• What are the standards?
• Completion of Documents – Data Entry – The Don’ts
• Make entries on the reverse side of the document
• Unless a note is written on the front page
• Leave spaces blank
• If unused, cross-out or enter "N/A" (or similar text)
• Use pencils!
• Entries must be in indelible ink
• Use ditto marks (‘’)
• Use continuation lines
• Use signature stamps
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 Good Documentation Practice
• What are the standards?
• Completion of Documents – Data Entry – The Don’ts
• Obliterate data / entries - original data / entries must
remain legible
• Overwrite data / entries – scribble / marker
• Use Corrective Solutions (e.g., Wite-out®)
• Use Corrective Tape
• Omit data
• Falsify data
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 Good Documentation Practice
• What are the standards?
• Completion of Documents – Data Entry – The Don’ts
• Back date
• Use current date and include an explanation of the
delay
• Destroy or remove pages – obscures data that were
present
• To invalidate a page,
use a single line cross-out,
then initial and date it.

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 Good Documentation Practice
• What are the standards?
• Completion of Documents – Data Entry – The Don’ts
• Transcribe Data – obscures original data
• Data Transcription may prove helpful if original is of
poor quality writing or is physically damaged
• If used, should be clearly marked as a transcription
and the original retained.
• Use Scrap Paper or Post-it® Notes
to record raw data
• Temporary, non-official record
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 Good Documentation Practice
• What are the standards?
• Completion of Documents – Data Entry – The Don’ts
• Use asterisks (*) where there is insufficient space
for a fully notated hand change
• Use a number near the correction, and record the same
number along with a notation where this is sufficient
space.
• Reduces the risk that an additional change made by
another person will not use the same mark.
• Sign / initial for another person
• Can sign of behalf of the other person, but must identify
this along with an explanation.
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 Good Documentation Practice
• What are the standards?
• Reproduction of Documents – Copying
• Clear and Legible
• No Errors are introduced
• Copy must remain identical to the original
• Watermarks are sometimes used to identify
original document from copies.

F T
D RA
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 Good Documentation Practice

• What are the standards?

• Maintenance of Documents
• Periodically Reviewed to Keep Current
• Securely Retained
• Change Control Program
• Controlled Availability for Appropriate Duration
• Electronic Document Management Systems (EDMS)
must be Validated
• Electronic Records are Backed-up and Archived
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 Good Documentation Practice
• What are the standards?
• Modification of Documents – Change
• Handwritten modifications – signed/ dated
• Altered text is not to be obscured
• Justification for alteration must be noted
• Controls to prevent use of superseded documents
• Versions can only be modified by authorized personnel
• Access to electronic versions must be controlled by
password or other means
• A history (audit trail) must be maintained of changes
and deletions to electronic versions
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 Good Documentation Practice
• Data
• Significant Figures: All non-zero digits are
significant, all zeros to the left of a nonzero
digit are not significant, and a decimal point
has no bearing on what numbers are significant.
• The number of significant figures in the final
result is determined by the significant figures
of the original numbers.

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 Good Documentation Practice
• Data
• Significant Figures: (Continued)
• Examples:
• 67 mg - All digits are significant - no “0”s.
• 0.067 g – Two digits are significant – “6” and “7”.
The “0”s are not significant - only hold decimal place.
• 0.0670 g – Three digits are significant - “6”, “7” and
the far right “0” which identifies the limit that the
substance was weighed to (0.0001 g).

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 Good Documentation Practice
• Data
• Significant Figures:
• Examples: (Continued)
• 670 mg - Two digits are significant – “6” and “7”;
however, the “0” may or may not be significant.
• The “0” may hold the decimal place in which case
it is not significant.
• The “0” may identify the limit that the substance
was weighed to (1 mg).
• Resolutions:
- Record value as 0.67 g or 0.670 g
- Use scientific notation. 23
 Good Documentation Practice
• Data
• Significant Figures: (Continued)
• Using Significant Figures for Calculations
• Addition and Subtraction: Final value has only as
many figures to the right of the decimal as there
are in the number having the least number of
figures to the right of the decimal.
• Example:
111.1
+ 22.22
- 3.333
136.653 136.6 24
 Good Documentation Practice
• Data
• Significant Figures:
• Using Significant Figures for Calculations (Continued)
• Multiplication and Division: Final value only has
many figures as in the value with the least number
of figures.
• Example:
11.1
x 0.022222
0.2466642 0.246
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 Good Documentation Practice
• Data
• Significant Figures:
• Using Significant Figures for Calculations (Continued)
• Scientific Notation: All values expressed as 10# with
one significant figure to the left of the decimal point.
• Examples:
1.0000 x 102
2.02020 x 102
1.23 x 10-2
2.02020 x 10-1
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 Good Documentation Practice
• Data (Continued)
• Rounding-off: Process by which one reduces the
number of figures in a value.

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 Good Documentation Practice
• Data
• Rounding-off: (Continued)
• Focus on the digit to the right of the last place in
the limit expression.
• If this digit is < 5, it is eliminated and the preceding
digit is unchanged.
• If the digit is > 5, it is eliminated and the preceding
digit is increased by one.
• If this digit = 5, the 5 is eliminated and the preceding
digit is increased by one.
• For calculations, do not round values until final
result is calculated. 28
 Good Documentation Practice
• Data (Continued)

• Truncation: Reduces the number of figures in a

value by deleting the unnecessary figures.

• No other change is made

to the remaining number.

• Unlike Rounding-off, only the last several digits

in a numerical string are dropped.

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 Good Documentation Practice
• Data
• Truncation: (Continued)
• Consider the significance of digits to the final
result.
• Do not truncate values until the final result is
calculated.
• Example:
Values not truncated prior to calculation:
456.789 x 0.1234 = 56.36
Values truncated prior to calculation:
456 x 0.1 = 45.6 30
 CONFIDENTIALITY
• What’s the Big Deal?
• Company’s Code of Ethics
• Adopted by companies to enable employees to:
• Understand difference between 'right' and 'wrong'
• Apply understanding to their business decisions.
• Implies documents at three (3) levels:
• Codes of Business Ethics
• Codes of Conduct for Employees
• Codes of Professional Practice
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 CONFIDENTIALITY
• What’s the Big Deal?
• Codes of Professional Practice (Continued)
• Honesty
• Integrity
• Transparency
• Accountability
• Confidentiality
• Objectivity
• Respectfulness
• Obedience to the Law
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 CONFIDENTIALITY
• What’s the Big Deal?
• Codes of Professional Practice (Continued)
• Confidentiality - "confidential information"
• Trade Secret:
• A formula, practice, process, design, instrument,
pattern or compilation of information
• Not generally known or reasonably ascertainable
• Require reasonable measures to protect the
information
• Enables a company to obtain an economic
advantage over competitors
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 CONFIDENTIALITY
• What’s the Big Deal?
• Trade Secret (Continued)
• Impact:
• Intellectual Property:
• Copyright
• Patent
• Trademark
• Time To Market
• Competitive Advantage
• MONEY!

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 Summary
• GDPs are considered cGMP.
• All employees must follow GDPs.
• Original data and entries must not be
obliterated; must remain legible.
• Follow the GDP Dos and Don’ts.
• Always use the current date.
• Know what you are signing/initialing.
• Follow company policies/SOPs on significant
figures, rounding-off and truncating values.
• Protect your company’s trade
secrets by maintain confidentiality. 35
END

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