| Vendor | Data Integrity
Report Status | Audit Status | In USA or OUS | Location | Services
Audited | GxP
Area | Audit
Type | Audit
Method | Proposed
Quarter | VRTX QA Coordinator | CSQA Auditor | TW Report Number | Date of Intake | Date Q sent | Date Q Rcvd | Date On Site
Scheduled | Audit Start Date
| Audit End Date | Date Final
Report Due | Date of audit pre-scope meeting | Date of audit debrief meeting | Date of
Completion | Notes |
| CS Vendor 1 | (unknown) | Completed | OUS | Leeds, UK | Hosted artwork management system, | GIS | On Site | Qualification | Q1 | AlI Karaa | JA | 22401 | 1/19/17 | (unknown) | (unknown) | 1/30/17 | 3/1/17 | 3/2/17 | 4/1/17 | (unknown) | 3/2/17 | 4/10/17 |
| CS Vendor 2 | (unknown) | Completed | USA | Cincinnati, OH | Computerized Systems | GMP | On Site | Requalification | Q1 | WS | WS/ CL | 22586 | 2/22/17 | (unknown) | (unknown) | 2/22/17 | 3/29/17 | 3/30/17 | 4/29/17 | (unknown) | 4/7/17 | 4/28/17 |
| CS Vendor 3 | (unknown) | Completed | OUS | Wommelgem, Belgium | | GIS | On Site | Requalification | Q1 | WS | WS | 22760 | 2/22/17 | (unknown) | (unknown) | 2/22/17 | 3/7/17 | 3/8/17 | 4/7/17 | (unknown) | 4/6/17 | 4/7/17 |
| CS Vendor 7 | (unknown) | Closed | USA | Princeton, NJ | Manged Service provider for system | GIS | On Site | Qualification | Q1 | AlI Karaa | MD | 23849 | 3/8/17 | (unknown) | (unknown) | 5/31/17 | 7/25/17 | 7/26/17 | 8/25/17 | 7/11/17 | 8/1/17 | 10/4/17 |
| CS Vendor 9 | (unknown) | Completed | USA | Pleasanton, CA | DMS | GIS | On Site | Requalification | Q3 | Ali Karaa | AA | 23804 | 4/3/17 | (unknown) | (unknown) | 6/20/17 | 8/22/17 | 8/23/17 | 9/22/17 | 7/10/17 | 8/28/17 | 9/27/17 |
| CS Vendor 10 | (unknown) | Completed | USA | Greenville, NC | Quality Systems Assessment; Software Development Life Cycle Process; Software Design, testing and implementation; change control and configuration management; 21CFR Part 11 capabilities; Problem reporting; Disaster recovery; Supporting SOPs and Test Evidence | GIS | On Site | Requalification | Q3 | Ali Karaa | AA | 23585 | 4/3/17 | (unknown) | (unknown) | 5/24/17 | 7/18/17 | 7/19/17 | 8/18/17 | 6/29/17 | 7/24/17 | 8/18/17 |
| CS Vendor 15 | (unknown) | Completed | OUS | Richmond, BC Canada | GMP Temperature and Humidity Monitoring System | GIS | On Site | Requalification | Q3 | Ali Karaa | CL | 23812 | 4/3/17 | (unknown) | (unknown) | 6/15/17 | 8/14/17 | 8/15/17 | 9/14/17 | 7/25/17 | 8/22/17 | 9/27/17 |
| CS Vendor 17 | (unknown) | Completed | USA | Princeton, NJ | Quality Systems Assessment; System Life Cycle Process; Software Design and Testing; Change Control; User Acceptance Process; Part 11 Assesment; Security, Network and Disatser Recovery Controls; A selection of related SOPs and validation documentation (filed in ) | GIS | On Site | Requalification | Q3 | Ali Karaa | MD | 23536 | 4/3/17 | (unknown) | (unknown) | 5/26/17 | 7/13/17 | 7/13/17 | 8/12/17 | 6/30/17 | 7/18/17 | 8/11/17 |
| CS Vendor 18 | (unknown) | Closed | USA | Cary, NC | SDLC ( Software Development Life Cycle) and SLC (System Life Cycle) processes. | GIS | Questionnaire | Requalification | Q3 | Ali Karaa | MD | 23535 | 4/3/17 | 6/16/17 | 6/30/17 | (unknown) | (unknown) | (unknown) | 7/30/17 | (unknown) | (unknown) | 8/10/17 |
| CS Vendor 19 | (unknown) | Closed | USA | Burlington, MA | Tape Vaulting Services | GIS | On Site | Requalification | Q3 | Ali Karaa | BM | 23426 | 4/3/17 | (unknown) | (unknown) | 5/24/17 | 7/11/17 | 7/11/17 | 8/10/17 | 6/27/17 | 7/14/17 | 8/10/17 |
| CS Vendor 21 | (unknown) | Completed | USA | Palo Alto, CA | Software Service Provider | GIS | Questionnaire | Requalification | Q3 | AlI Karaa | CL | 23995 | 7/11/17 | 8/7/17 | 8/29/17 | (unknown) | (unknown) | (unknown) | 9/28/17 | (unknown) | (unknown) | 9/28/17 |
| CS Vendor 23 | (unknown) | Completed | USA | Boston, MA | Data Review Process | GCP | On Site | Internal | Q2 | AlI Karaa | JR | | | | | | | | | | | 7/13/17 |
tututt
CSQA_Audit_Data.xlsx
