Good Documentation Practices

1 © 2016 Bioclinica – Proprietary and Confidential

 Agenda

 When are GDPs Used?

 Responsibilities

 Definitions

 General Information

 Date Format Examples

 Specifics for GDPs and Testing Documentation

2 © 2016 Bioclinica – Proprietary and Confidential

 When are GDPs Used?

•Documents associated with:

– Software Development
– Test Scripts (IQ/OQ/PQ)
– Specifications
– Forms / Templates
– Study Specific Documents
– DM Plans and associated Documents
– Official Memos
– Training Documentation
– Documents with “wet” signature

3 © 2016 Bioclinica – Proprietary and Confidential

 Documents NOT included
– Human Resources Documents
– Finance Documents
– Sales and Marketing Documents

4 © 2016 Bioclinica – Proprietary and Confidential

 Responsibilities

• All BioClinica Personnel are required to follow these guidelines.

• Managers and employees are required to ensure that they are trained and follow GDPs

• QA is responsible for ensuring these procedures are followed

5 © 2016 Bioclinica – Proprietary and Confidential

 Definitions

•GDP - Good Documentation Practices: Documentation practices that ensure

the reliability, legibility, and integrity of our official documents
•Official Document - Any BioClinica document which is used to provide or
record information pertaining to BioClinica activities

•Legible - Able to be read. The legibility is determined by the reviewer of any

documentation
•Indelible Ink - Ink that will not smear when wet or disappear over time

6 © 2016 Bioclinica – Proprietary and Confidential

 GDP General Information

7 © 2016 Bioclinica – Proprietary and Confidential

 General Information

What is GDP?
• Good Documentation Practice (GDP) is the standard by which documents are
created and maintained.
• GDP standards cover the following areas:
• Document Creation
• Document Approval
• Handwritten Entries
• Copies of Documents
• Document Maintenance
• Document Modification

8 © 2016 Bioclinica – Proprietary and Confidential

 General Information

Document Creation
• Contemporaneous with the event they describe
• Not handwritten (except for handwritten entries thereon)
• When electronically produced, the documentation must be checked for
accuracy
• Free from errors
• For some types of data, the documentation must be in a format that permits
trend evaluation

9 © 2016 Bioclinica – Proprietary and Confidential

 General Information

Document Approval
• Documents must be Approved, signed and dated by appropriate authorized personnel

10

10 © 2016 Bioclinica – Proprietary and Confidential

 General Information

Handwritten Entries
• Adequate space is provided for expected handwritten entries
• Handwritten entries are in indelible ink
• Blue or black ink only. No colored pens, no rollerball or gel ink (Pilot pens)
• Critical entries must be independently checked
• SPV – second person verified
• No fields that are to contain handwritten entries are to be left blank
• Ditto Marks or continuation lines are not acceptable
• Signatures must be actual signatures – signature stamps are not acceptable

11

11 © 2016 Bioclinica – Proprietary and Confidential

 General Information

Copies of Documents
• Copies must be clear and legible
• Errors are not introduced during the copying process

12

12 © 2016 Bioclinica – Proprietary and Confidential

 General Information

Document Maintenance
• Documents should be:
• Regularly reviewed and kept current
• Retained and available for an appropriate duration
• If used, electronic document management systems are to be validated for use
• Electronic records are backed up

13

13 © 2016 Bioclinica – Proprietary and Confidential

 General Information

Document Modification
• Handwritten modifications are signed and dated
• Altered text is not obscured (e.g., no White-Out)
• Where appropriate, the reason for alteration must be noted
• Controls exist to prevent the inadvertent use of superseded documents (Version
control)
• Electronic versions of documents 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
• Revision History

14

14 © 2016 Bioclinica – Proprietary and Confidential

 General Information

FDA uses the ALCOA standard to determine whether GDP is being followed
• ALCOA
• Attributable – must be able to clearly identify who has taken the action
• Legible – must be readable
• Contemporaneous – signing must be done at the time the activity is taking place (no post or back dating)
• Original
• Accurate

15

15 © 2016 Bioclinica – Proprietary and Confidential

 General Information

• Signature – use your legal signature

• Initials – Use 3 initials (First, middle, last name)
• Time Format – May use either AM/PM or 24 hour clock (military time)
• Entries must be made using blue or black indelible ink (ballpoint pens). Colored ink, rollerball, or
gel pens are prohibited.

16

16 © 2016 Bioclinica – Proprietary and Confidential

 General Information

• All comments made in either a margin or in the comments section of a

document must include the initials of the person entering the
comment and the date that the comment is added.

• Use “N/A” for Not Applicable to indicate an entry is not required in the
space (e.g. text box) provided.

17

17 © 2016 Bioclinica – Proprietary and Confidential

 Date Format

• Date Format – European: DDMMMYYYY

– E.g., today is 04JAN2016
• The following Date Formats are acceptable:
04-Jan-2016
04Jan2016
04.Jan.2016
• The following Date Formats are UN-acceptable:
1/04/16
01/4/16
1-04-16
01-4-16
04Jan16

18

18 © 2016 Bioclinica – Proprietary and Confidential

 Why do GDPs matter?

19 © 2016 Bioclinica – Proprietary and Confidential

 GDP and Testing Documentation

Why do GDPs matter?

• Not an official part of regulation; they’re not law
• Industry standard for proving adequate control over documents
• Part of BioClinica’s formal procedures
• Work that is not compliant with GDP will require additional steps and more
work to complete

20

20 © 2016 Bioclinica – Proprietary and Confidential

GDP and Testing Documentation

21

21 © 2016 Bioclinica – Proprietary and Confidential

 GDP and Testing Documentation

22

22 © 2016 Bioclinica – Proprietary and Confidential

 Thank You!

23 © 2016 Bioclinica – Proprietary and Confidential