A Practical Guide to Maintaining Data Integrity Date: November 2018 Version: V1.

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Author: Hannah Demir Page: 1 of 7

Good Documentation Practices

A Practical Guide to Maintaining Data Integrity

Contents
Manual Data Recording
Hand Wrien Documents ....2
Scrap Paper ....3
Transcribing Data ....3
Late or False Entries ....3
Log Books ....4
Suppoing Documents ....4
Equipment Print Outs ....4
Launguage & Grammar ....5

Electronic Data Recording

Electronic Passwords ....5
Rounding of Data ....6
Data Archiving ....6
E-Data Backup, Recovery & Retention ....6
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Manual Primary Data Recording

Hand Wrien Documents

Best Practices:

- Always use pen with indelible ink

- Initial and date all entries (unless a signature is required)
- Where a signature is required, a first initial and a full name must be printed
- Always document each step before moving to the next step.
- Use the latest templates and protocols from approved procedures.
- Record any calculated numbers less than one, with a zero before the decimal point
- Records which contain placeholders or spaces for information to be entered should be completed even if they are not
applicable or required. Ensure N/A is entered to indicate the field has no purpose and hasn’t just been ‘missed’. This also
prevents any unauthorised data being entered into blank fields; post the document approval.
- An explanation may be required if the step/field is being missed intentionally
- If a full page is not required, strike through across the page before writing N/A, your signature and date
- Ensure any corrections are made appropriately,
- Correct errors by crossing through with a single line, leaving the original data legible. Provide an annotate with an
explanation, initial and date the correction e.g. ‘Transcription error'.

28.4
EH 07/01/2015
28.4 Transcription Error
NOT:

When completing hand wrien records, DO NOT:

- Overwrite. - Approve, verify, or review your own performance.

- Use liquid correction fluid. - Remove original pages from a log book, lab book or work
- Use pencils. package
- Backdate. - Record primary data on scrap paper, post it notes or similar
- Record data before the action or event has occurred. but directly in approved logbooks, laboratory notebooks and
- Use dio marks. data packages.

This document is an example of how

hand wrien documents should be
corrected by striking through incorrect
entries, annotating with explanations
and marking N/A instead of leaving
blank spaces

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Scrap Paper, Post-it Notes and Personal Notebooks

When transcribing data, always enter data directly into a
controlled record (e.g. data package or lab notebook) as this is
considered the original. You must never enter data onto scrap
paper or a rough notebook to be transcribed later.

Remember:
- Scraps of paper can be lost and are not replaceable!
- Errors can be made in transcribing from rough note books.
- Operations or tests that have to be performed in parallel but in
two separate areas should use specific GMP forms or log books
which can be controlled and have an audit trail. Information from
these sources can then be transcribed into the original
document at a later date as they have full traceability.

Transcribing Data

What is impoant when transcribing data?

Anything that is transcribed to an original must be traceable and verified by a second person against the source docu-
ment

When is it acceptable to transcribe data?

Transcription should be the exception and only used when:
- Records have been severely torn or damaged
- Records are transferred from paper to an electronic system in accordance with local procedures. (The transferred data
may need to be checked by a second person)
- The data was collected on a controlled traceable form or similar
- The data in the original source document has become illegible

Late or False Entries

What if I forget to sign a record or don’t check it on the correct date and time?
BE HONEST!
- Never back date information! This can be seen as fraud and is therefore illegal
- Enter the current date and provide a brief explanation
- Never remove, change or obliterate data
- Do not fabricate data or intentionally misrepresent it
- Don’t sign on behalf of someone else
- Don’t sign if you haven’t performed, or checked/approved the task or document

Remember, we are all responsible for maintaining

reliable and trustwohy data. Doing so ensures that
our products are high quality and safe for our
consumers

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Log Books

A logbook is a documentary record of a sequence of related events. Typically used to record equipment or room use,
each page should be reviewed by an appropriate approver and signed. They should also...

- Contain the date and time of each recorded event and the signature of the person recording it
- Have a unique identifying number associated with it that is issued by a controlled process
- State the identity and purpose of the logbook at the beginning of the book
- Include suppoing printouts as aachments, where required
- Be set out in such a manner that it is clear what data is required, even to the unpractised user
- Have no gaps le between the individual entries
- Be individually numbered & bound and be able to withstand wear and tear
- Contain all pages, with no pages removed. Mistakes or gaps should be corrected as described previously. All sections
should also be completed at the time of use

Suppoing Documents

Additional documents may be created containing suppoing information to a

parent document, however traceability must exist between all aachments and
the parent document.

All aachments should be:

- Paginated – e.g. Page 1 of 10
- Clearly cross referenced or identifiable to the source/parent document
- Dated, signed or initialled by the person adding the aachment
- Aachments should not be removed from documents
- Any document should be able to be shuffled or dismantled and be able to be put
back together correctly through clear pagination and references - this is refered to
as the ‘Drop Test’

Equipment Print Out

- All data on equipment printouts must be identified, dated and signed

- Include instrument identification number, any logbook number, and the
identification details of the material(s) to which the data refers
- Smaller printouts to be self-adhesive backed or aached with glue
- The method of aachment must be strong enough to prevent accidental
loss of information
- Photographs, the information should be wrien on the back before
aaching to the laboratory notebook or data package as described
- If the data is required to be photocopied to suppo other information –
this should be also signed & dated as being a true copy and cross
referenced to the original source location for traceability

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Language & Grammar

Language
- English is the recognised language for RB and all documentation
should be created in English

Grammar
- Never use slang or text style abbreviations

Abbreviations & Acronyms

- Use the full word the first time that it is introduced in a document
and the abbreviate aerwards
- Consider the use of a “glossary” or “table of abbreviations”
- If numbers are involved always use them with the appropriate
unit of measure e.g. 16 cm, 5 kg, etc

Electronic Data Recording & Signatures

Electronic records also require good documentation practices

- Computer systems should be validated to the appropriate standard

- All electronic documents should be version controlled when amended
- Number pages (drop test) and add a file path to documents which are on shared drives
- Electronic signatures are equally as valid and legally binding as handwrien signatures
- Access level granted to individuals must be appropriate to their tasks and responsibilities
- Measures shall be taken to prevent the use of shared logins. Generic user access is not permied
- Electronic data will be backed-up and data recovery procedures will be implemented in accordance with local SOPs

Electronic Passwords

It is the responsibility of the individual to:

- Construct passwords in accordance with the procedures for
specific equipment or computer systems
- Construct passwords without reference to familial personal names (e.g.
spouse’s names, pet’s names etc.) or names that might be easily
associated with them (e.g. favourite football team, nicknames; etc.)
- Construct passwords with a minimum length of 8 characters using a
mixture of alphabetic and numeric characters
- Ensure that their password is confidential

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Rounding of Data

- Calculation factors in methods must be used in full

- When using a calculator, use the internal memory for intermediate calculations
- Do not round until the end of the calculation
- Where a calculation involves the recording of an intermediate figure, the figure must be recorded to at least five
significant figures e.g. 12345, 1.2345, 12.345, etc
- Final figures are rounded to the significant place, as required to be quoted in the result
- Use the simple rule that a '5' or more in the final column is rounded to the next highest unit e.g. 97.500 is rounded up
to 98 if two significant figures are required, whereas 97.400 is rounded down to 97
- When performing dissolution testing, there is an exception to these rules, as data must be rounded down to present a
‘worst case’ result

Data Archiving

Data archiving is the process of moving data that is no longer

actively used to a separate storage location for long-term
retention (manual and electronic data). Archive data consists of
older data that is still impoant to the organization and may be
needed for future reference, audits, etc. as well as data that must
be retained for regulatory compliance or to comply with
corporate policy.

- An on site/off site facility will be used to store paper documents

- Access to this facility will be restricted and controlled
- When data has reached its retention period it will undergo controlled
destruction

Why archive data?

- Data is easier and quicker to find, speeding up data access in event of an inspection or audit
- It is also more secure and prevents data loss, reduces the risk of losing or misplacing data through disorganisation

E-Data Back Up, Recovery and Retention

- Electronic data with be backed up and data recovery

procedures will be implemented in accorance with local
SOPs
- Computer systems will generate copies of electronic
records that preserve the content and meaning of the
records for the defined retention period
- These records must be readable. This includes the
audit trail (if applicable) and the batch records (if
applicable)
- A method of safely retaining the content and meaning
of records throughout their retention period will also be
documented and tested

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Thank you for taking the time to read this

Practical Guide to Maintaining Data Integrity.

If you have any additonal queries, please contact

Global.QualityCompliance@rb.com