Recording Data
The time when it is acceptable to sign for activities you did not perform, witness, or have not verified.
NEVER
The original performer
It Means it Didn't Happen
If you didn't sign for it
The correct and best format to use for date
DDMMMYYYY
Must be evaluated before making corrections
Impact to product quality
Must be completed before physically advancing to the next step.
PMX Ticket/Record Signatures
Must be provided when making a correction
A reason/comment/note
Yearly mandatory document for ensuring attributability
Signature Log Book
GMP time sources that can be used for recording time for GMP activity
• Validated computer systems with time synchronization
• Qualified equipment/instruments where time is automatically synchronized to a time server through network time protocol (NTP)
• Networked clocks or other time sources where changing the time is inaccessible to someone other than an administrator.
When you can make corrections without being considered a data integrity lapse
Contemporaneous/time of error
The activity to be done every time before advancing the ticket or batch record.
Review the page for completeness/accuracy.
The Acronym for corrections
CLIDE (correct, line-out, initial/sign, date/time, explain)
Your first course of action if you are unsure on a GDP issue.
Check the SOP PRD-94123 RTP-PRD-Good Documentation Practices
Signature type for a trained and/or qualified individual that executes a task.
Performed By
Must be notified if data integrity errors occur.
QA shopfloor support/Supervisors
True/False
Can you complete non-signature PMX steps under another employee's login?
False
Even when not signing for a step the person performing the step must be the Network ID logged into that station.
Must be part of corrections on omission errors
• Document the evidence, or a reference to the evidence, that supports the occurrence of the task or missing information.
• Document the reason for the initial data omission.
• Initial and date the entry.
• Obtain a QA countersignature.
Notes added to GMP documentation and records (in both paper and electronic formats) provided the actions do not modify the process or affect the basis or the intent of the original instructions.
Clarification
Signature type for trained and/or qualified individual to confirm original records (or true copies) for accuracy, legibility, consistency, completeness, and compliance according to a defined process or procedure.
Reviewed By
These are documentation requirements for manual calculations
Manual calculations, units of measure, conversion factors, and equivalency factors must be clearly documented.
An unexpected occurrence identified during a GMP activity, where there is no defined procedural response in place that assures quality is not impacted.
Deviation
Required Approvers for any change from our standard process
QA/TSMS
Required for corrections impacting product quality, omissions, process change, made during/after review, or a clarification.
QA Countersignature
The difference between the witnessed by and verified by signature types
Real time observation
Errors where QA must determine if there is sufficient supporting data to indicate that data correction is appropriate when data has the potential to impact product quality
Raw data erroneously recorded out of acceptable limits where exceeding the limit has the potential to result in a product quality issue
Time and/or date data supporting the execution of a time critical GMP activity erroneously documented