year 2015
Audit: the week of November 2, 2015.
Submit:
- test methods for all appendices to be assessed,
- method validation for any new appendices,
- any supporting standard operating procedures,
- an electronic copy of the quality manual,
- internal audit records, and
- management review minutes.
As well, one (1) hard copy of the quality manual must be submitted. The Laboratory Quality System Document Review Form (A18) (see link below) must be completed and submitted with the quality manual.
All required documents and records must be submitted to CALA before September 21, 2015.
***I engaged everyone *** This is a time-sensitive matter. I need your support by putting it as your top priority.
CALA wants documents including QAP by Sep. 2nd. Stephen, Laverne and I have done lots of work to revise the draft. Stephen recommended submitting the revised QAP to CALA. The review process in TRAK could take long time. We only have two weeks to work with.
Here is my plan:
- I am going to send the draft to you by the end of the day today. We are going to review the QAP outside of TRAK. If you could send back your comments by Aug. 26th, that would be awesome. Stephen has done an excellent work on the QAP, I think you should find less concerns/clarifications. I will review comments, and send the ready-to-be-uploaded draft to you by Aug. 28th. Once I get it uploaded to TRAK, we only have to click approve box.
- Nicole/Neil, could you please ask CALA for extended due date? A couple of weeks would help us a lot in case we could not meet the due dates I proposed.