Analysis
* GxP: guideline for ‘Good working Practice’ pertaining to various branches of the pharmaceutical industry.
*CSQA: Computerised System Quality Assurance
|
Field Name |
Data Type |
Description |
|
Vendor |
CHAR (10) |
Vendor number ID |
|
Audit Status |
CHAR (15) |
Closed/Not in Scope/In Process/ Pending/Completed |
|
In USA or OUS |
CHAR (3) |
Activity take place in United State or outside of United State |
|
Location |
CHAR(20) |
In U.S: City, State Outside U.S: City, Country |
|
Vendor Primary Contact |
VARCHAR |
Vendor Primary Contact Information |
|
Vendor Secondary Contact |
VARCHAR |
Vendor Secondary Contact Information |
|
VRTX Business Sponsor |
CHAR |
Vertex Business Sponsor initial |
|
Service Audited |
CHAR |
Vertex Service |
|
GxP Area |
CHAR (3) |
GCP: Good Clinical Practice audits. GLP: Good Laboratory Practice audit. GMP: Good Manufacturing Practice, audits of manufacturing sites. GDP: Good Distribution Practice, audits of distribution and logistic partners. GVP: Good Vigilance Practice, Audits of pharmacovigilance service providers |
|
Audit Type |
VARCHAR (40) |
Qualification/Requalification/Requalification with Questionnaire/Questionnaire |
|
Audit Method |
VARCHAR (30) |
None/On-site/Questionnaire in 2016/Questionnaire/Remote/None/TBD, on-site * CSQA did not participate |
|
Proposed Quarter |
CHAR(6) |
Quarter 1/Quarter 2/Quarter 3/Quarter 4/Quarter 3 and 4 |
|
VRTX QA coordinator |
CHAR(3) |
QA coordinator initial |
|
GxP Auditor |
CHAR(5) |
GxP auditor initial |
|
CSQA Auditor |
CHAR (5) |
CSQA auditor initial |
|
TrackWise (TW) Report Number |
NUMBER (5) |
TrackWise system generated reports number |
|
Date of Intake |
Date |
|
|
Date Questionnaire sent |
Date |
Questionnaire sent date |
|
Date Questionnaire received |
Date |
Questionnaire received date |
|
Date on Site Scheduled |
Date |
On-site audit date |
|
Audit Start Date |
Date |
Audit process start date |
|
Audit End Date |
Date |
Audit process complete date |
|
Date Final Report Due |
Date |
Audit final report due date |
|
Date of Completion |
Date |
Audit final report actual complete date |
|
Date Observations sent to Vendor |
Date |
Observations form sent to vendor to review |
|
Observation Responses Due |
Date |
Require observation response due date |
|
Date Observation Responses Received from Vendor |
Date |
Actual date observation responses received from vendor |
|
Observations |
CHAR (10) |
Major/Minor |
|
Observations in TW |
VARCHAR(30) |
Observations outcome in TrackWise |
|
Observation Due date |
Date |
Observation required due date |
|
Observation Assigned to |
CHAR(2) |
Observation assigned auditor initial |
|
Closed Date (Observation closed in Trackwise) |
Date |
Observation completed date |