AUDIT SURVEY

This web site is designed to facilitate customer vendor audits and qualification.

This page was last updated in October 2008.

Here are the most frequently asked questions (FAQ) regarding our testing laboratory.

CONTACT INFORMATION (only location):
Ultimate Labs
5940 Pacific Mesa Court, Suite 209
San Diego, CA 92121
Phone: (858) 677-9297
Fax: (858) 677-0716

E-mail: info@ultimatelab.com
Website : www.UltimateLab.com

Person(s) responsible for questionnaire completion:
Kim Lim, Founder and Owner, (858) 677-9297

Products and services:
We currently offer environmental monitoring and microbiology services.

Date established: 2007

Number of employees: 10 +/-

Quality:
Our Company routinely operates under ISP and GXP as a Quality laboratory. Quality is one of the independent monitoring functions of our Operations. Quality function is performed by our technicians while conducting the tests to monitor precision, accuracy, and any other analytical testing criteria. Quality is performed by our technicians as they are performing the tests. Another final Quality review will be conducted prior to the release of all the test results.

Ultimate Labs has authored a Quality Manual and created a formal Quality Program which is in compliance with ISO standards and GXP guidelines. The Quality Manual is routinely reviewed and revised annually unless there are significant changes that require prompt updates. We expect to be ISO and GLP compliant very shortly.

ISO Certification: Download Certificate (.pdf)

FDA Registration Number: Status Pending

CA ELAP Certificate: Status Pending

Is Ultimate Labs subject to inspection or audit?:
Yes. Regulatory Agencies and our clients routinely visit our labs for inspection and audits.

Quality Policies
A) Raw Materials Control, Supplier Qualification - Procedures are in place

B) Instrument Calibration - Procedures are in place

C) Training - Procedures are in place

D) Document Control - Procedures are in place

E) Customer Complaints - Any question or complaint expressed by our client will be logged on a Complaint Form and a prompt investigation will be conducted. We strive to resolve any concern lodged by our client in a manner that will satisfy by both parties.

F) Nonconforming Work Policy - A nonconforming work investigation will be conducted there were any excursions. Retest is expected and performed in an expedited manner.

G) Traceability - All test measurements are traceable to NIST through the use of traceable weights and measures, as well as the use of reference samples from NIST and USP.

H) Client notification of quality problems - Reports includes data precision and its accuracy. Any outliers affecting its quality will be highlighted in the report.

I) Deviations from methods and SOPs - For GLP purposes, planned deviations require preparation of amended SOPs and Quality approval.

Unplanned deviations are common because either the sample matrix is not covered by the method because of unexpected interferences, or the method is not clearly written. In any case, unplanned deviations in methods or SOPs are documented in the sample preparation bench sheet, the analysis bench sheet, and the data package signature page.

Ultimate Labs reserves the right to modify the methods in our standard Terms and Condition should there be any problems with sample matrixes, methods and newly discovered scientific information. Modifications are taken seriously and will be documented. Significant modifications in sensitive regulatory areas will be made only with the consent of our client.

J) Record retention - Raw data is stored for five years as paper archives and indefinitely electronically. The record will include hard copies of all raw data report with complete explanations of sample preparation and analysis and a copy of the report submitted by an independent QA reviewer.

K) Instrument Qualification – Qualifications performed and furnished upon request.

L) Method Validation - Some of the methods and SOPs have been validated. However, methods from compendia sources such as USP, ACS, and EPA do not require validation. Instead they go generally require system suitability or an initial demonstration of performance. Methods developed by Ultimate Labs may be validated.

M) Expiration dates - Dates are documented on reagents and standards.

N) Sample storage and disposal - All samples are stored according to label requirements or USP protocols. Refrigerators and incubators are monitored with a temperature monitoring system that has a call-out function should there be any excursions. All samples that display growth will be processed and photographed. The reports will be furnished upon request.

O) Approval of test data - Quality will review and approve all data prior to its release to our clients. Any outliers will be documented and require approval of Quality before its release. Any results which are outside of material specifications will undergo a nonconforming work investigation. Any problems affecting the integrity of the data quality will be highlighted in the report. The final report will require a review and written approval by Quality.