Caprion

Accelerating precision medicine™

Quality Management Systems (QMS)

Caprion Biosciences state-of-the-art quality management systems (QMS) defines the high-level quality policies for all activities of our laboratory services. In accordance with applicable GCP/GLP/GCLP regulations, our quality management program is implemented at all levels of the organization where studies are planned, conducted, monitored, reported, and archived. Caprion is accredited by CAP and has the CLIA certification for specific testing methods and committed to providing the highest quality in the execution of all projects.


Immune response monitoring services in a GLP GCP GCLP quality management system



Quality Management Systems (QMS) policies for all activities encompasses the organization and facilities, safety and personnel, computer systems and equipment, sample management and chain of custody, assay/method qualification and validation, study planning, sample processing and data analysis, reporting, document control, storage and retention of data.

Processes and Procedures for Caprion’s QMS are performed by highly qualified and trained personnel and recorded in controlled documents such as study work plans, Standard Operating Procedures (SOP), Client Specific Procedures (CSP), and study worksheets/forms. All documents are approved prior to use.

Customized Assays that meets our sponsors study requirements, are planned, developed and qualified and/or validated prior to implementation.

Result Reporting format and mechanism for data reporting is developed in unity with the sponsor to ensure the highest quality of interpretation, correlation, and effective communication of test results.

Quality Control (QC) reviews ensure the performance of all laboratory testing for immune monitoring is controlled through the use of accepted quality control practices and documented procedures.

Quality Assurance (QA) audits performed by the Quality Assurance Unit are in accordance with GLP/GCP regulatory requirements, study plans and applicable procedures; in order to measure and monitor the performance of laboratory services, and to identify opportunities for improvement.

Proficiency Testing practices allow for the standardization of selected assays among laboratories, as required by the CAP accreditation and CLIA certification.


Caprion

Accreditations & Certifications

CAP accreditation and CLIA certification

CAP Accredited

Headquarters

+1 514.360.3600
+1 877.776.3443
141 President Kennedy Ave., Suite SB-5658
Montreal, Quebec
CANADA

USA

Primity Bio
48383 Fremont Blvd
Suite 118
Fremont, CA 94538
Tel.: +1 858.229.2529

Serametrix
2235 Farraday Ave,Suite N,
Carlsbad, CA, 92008, USA
Tel: +1 760 652 4060

HistoGeneX
1331 W 75th St #401,
Naperville, IL 60540, USA
Tel: +1 630-473-6655
info@histogenex.com

AUSTRALIA

Serametrix Party Limited
Suite 4/54-60 Briggs Street
Camperdown, NSW, 2050
Australia
+61 2 9168 5908

EUROPE

Caprion Biosciences Inc.
+32 (0) 71 96 23 36
8 rue Adrienne Bolland
6041 Gosselies
BELGIUM

Serametrix
Unit 22, Surrey Technology Centre,
40 Occam Road,
Guildford, Surrey, UK
GU2 7YG
Tel: +44 1483 685599

Antwerp, Belgium
HistoGeneX
Sint-Bavostraat 78
2610 Antwerpen (Wilrijk)
Belgium
Tel: +32 3 50 20 500
Sample Reception: +32 3 50 20 620
Shipments: +32 3 50 20 625

CANADA LAB

201 President Kennedy Ave., Suite PK-3900
Montreal, Quebec
CANADA
+1 514.360.3600
+1 877.776.3443



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Contact

+1 877.776.3443

info@caprion.com