The document focuses on the importance of data legibility in documentation, outlining guidelines for clear handwriting, font selection, formatting, and consistency to prevent misinterpretation. Current practices include using electronic documentation, maintaining quality control checks, and adhering to standardized operating procedures (SOPs) for legibility. Areas for improvement include regular training on data entry techniques and efficient use of electronic systems, along with regular audits of data management processes.

1. GROUP LEGIBLE
Group Members
Blessing Ndlovu
Nyaradzo Majola
Sicelo Moyo
Terrence Bhengo

2. LEGIBLE
DATA SHOULD BE EASY TO READ AND UNDERSTAND

3. LEGIBLE DATA
 Legible refers to the quality of being clear and easy to
read.
 Data Legibility is crucial for ensuring that the information
can be understood and interpreted accurately.
 Illegible documentation can lead to misinterpretation,
errors, and potential safety risks.

4. Guidelines to ensure legible
Documentation
1. Handwriting: If documentation is handwritten, use legible handwriting
techniques. Write clearly and neatly, using appropriate penmanship. Avoid
excessive pressure, which can result in smudged or blurred writing.
2. Font and Font Size: When using electronic or typed documentation, choose
a legible font and an appropriate font size such as Arial, Calibri, and Times
New Roman.
3. Formatting: Use formatting techniques to improve legibility. Use headings,
subheadings, bullet points, and numbered lists to break down information
into smaller, easily readable sections.
4. Consistency: Maintain consistency in formatting and style throughout the
documentation.
5. Spacing: Sufficient spacing improves readability and comprehension

5. WHAT WE ARE DOING RIGHT
 We have an SOP in place that outlines GDP and requirements for legibility,
and this SOP is enforced. Eg procedure for correction of errors.
 We are using electronic or typed documentation for consistency in
handwriting and easy input and retrieval of data.
 We are using digital data extraction and recording mechanisms (BPCRS
System) to reduce errors and make the data more legible.
 SOP 975.15 - The font size is large enough to be comfortably read,
especially for users with visual impairments.
 Our SOPs, specifications and reports are properly formatted and
structured which helps readers navigate the documentation and find the
information they need quickly.

6. WHAT WE ARE DOING RIGHT
 All our SOPs use the same font, font size, and formatting conventions
consistently (as per the SOP 975.15) to provide a uniform and cohesive
reading experience.
 Sufficient spacing is used which improves readability and comprehension
 Quality Control Checks – data is reviewed by the reviewers for legibility.
This also includes spot checking data records such as logbooks during
analysis work.
 Digital archieving systems are in place to preserve the intergrity of
electronic data, eg external hard drives and saving data on shared.
 Second person review of data generated during analysis to double-check
entries, using validated electronic calculation sheets.

7. THE GAPS
 Lack of regular training for all personnel on proper data entry
techniques and handwritting techniques.
 No regularly auditing of data management processes.
 Lack of guidance on using electronic systems efficiently.

8. AREAS OF IMPROVEMENT
 Conducting regular training for all personnel on proper data entry
techniques.
 Provide guidance on using electronic systems efficiently.
 Regularly auditing our data management processes to identify areas
for improvement.
 Implement regular Q.C Checks to review data entries for legibility by
spot checking data records.

9. REFERENCES
 SOP 975.15 Good Documentation Practices
 SOP 700.12 Data Intergrity
 Rao, Bayya & Reddy, B.. (2022). Understanding USFDA Guidance on
Data Integrity – ALCOA Plus-An Overview. Pharma Times. 54. 5-6.
 Lemay, P., (2022). ALCOA Principles: A Guide to Data Integrity for Life Sciences
Manufacturers. ALCOA Principles: A Guide to Data Integrity for Life Sciences…
| Tulip

10. THE END