wishing you all “a very happy new

8/14/2019 Wishing You All A Very Happy New

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Quality standards in

diagnostics A brief

overview

2

Brain Gym 2

Commitment to

Quality at RMx

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PTO to find

ReaDigest1 0 o f J a n 2 0 1 0V o l u m e 1 , I s s u e 4

Focus of the month

Quality Diagnostics

To know the answers for

Brain Gym, log onto

readigest.reametrix.com

Wishing you all

A very

Happy New Year

ReaMetrix employs a

highly process driven,c o s t - e f f i c i e n tapproach to product

development.

We not only makeproducts that aremore applicable to the

Indian market, but wedo it better, resultingin higher quality

products. For morei n f o r m a t i o n o nProcess Control atReaMetrix, please

visit.

To learn more about

us

Contact us

ReaMetrix India Pvt. Ltd,

50 B, 2nd Phase, TVS

Cross, Peenya Industrial

A r e a , P e e n y a

Bangalore- 560 058

India.Phone: +91 80 2837

8693

Fax : +91 80 4117 2451

Do you know?

The terms quality assurance and quality control are often used interchangeably to refer to ways of ensur-

ing the quality of a service or product. The terms, however, have different meanings.

Assurance: The act of giving confidence, the state of being certain or the act of making certain.

Quality assurance:

An overall management plan to guarantee the integrity of data (The system)

Control: An evaluation to indicate needed corrective responses; the act of guiding a process in which vari-

ability is attributable to a constant system of chance causes.

Quality control:

A series of analytical measurements used to assess the quality of the analytical data (The tools)

Dear friends,

Wishing you all a very joyful and successful 2010.

I am pleased to share with you another exciting

milestone in our journey to make innovative and affordable diagnosticproducts. We have entered into an agreement with BD Biosciences where

ReaMetrix will develop and supply reagents to enumerate CD4 and %CD4, inReaMetrix's room temperature stable, dried-down reagent format, for theFACSCount platform. BD and ReaMetrix entered into this agreement afteran extensive validation of ReaMetrix's manufacturing processes and

reagents.

To read the press release, please find the PDF attachment alongside

Through this, ReaMetrix will be able to have access to BD's extensive global

network of FACSCount instruments and increase the access for diagnosis inresource poor settings. This agreement is in effect for the %CD4 reagents

on the FACSCount platform only and does not prevent ReaMetrix in any wayfrom supporting its existing flow based products on

any system.

We wanted to share this good news with you andthank you for your trust in ReaMetrix's products. Your

support has ensured that we are motivated to achievethese milestones which make ReaMetrix the innovation

leader that it is today.We look forward to your continued support while we

hope to learn and grow with you.

FromC

EOsD

esk

Dr. Bala S. Manian


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2 We welcome your feedback, write to us at readigest@reametrix.

Brain Gym

Match the following diagnostic company with their respective products

Diagnostic company

1 ReaMetrix a C6 Flowcytometer

2 Accuri b ReaPan S34

3 Evogen c QuickCoag Reagents

4 Picoscope vehicle diagnostics d Ultra-Rapid PCR

5 Biomedica Diagnostics e Oscilloscope technology

Product

Quality Standards in Diagnostics A Brief overview

With the passing of the European direc-tive on in vitro diagnostic medical de-vices (IVDD 98/79/EC), the require-ments of in vitro diagnostic medicaldevices are binding for all member

states of the European Union. The di-rective includes product requirements,requirements on manufacture, placingthe product on the market, as well as

demands on safety and quality of the

products.

The IVDD does not apply to interna-tionally certified reference materials,

materials used for external quality as-sessment schemes, home brew products,products for general laboratory use and

devices for research purposes.

In vitro diagnostic products (IVDs), asdefined in 21 CFR 809.3(a), are those

reagents, instruments, and systemsintended for use in the diagnosis ofdisease or other conditions including adetermination of the state of health, inorder to cure, mitigate, treat, or pre-

vent disease or its sequealae.

Food and Drug Administration (FDA)expects the manufacturers choice of

procedures and processes rely on theFDA guidelines and thus ensures safety

and effectiveness of the IVDs.

ISOis the International Organizationfor Standardization. It was set up in1947 and is located in Geneva, Swit-zerland. Its purpose is to facilitateand support international trade bydeveloping standards that people

everywhere would recognize and re-spect. The eight quality managementprinciples - Leadership, involvementof people, process approach, system

approach to management, continualimprovement, factual decision- mak-ing, supplier relationships, customer

focused are interlinked.

ISO 9001:2008 retains the genericnature wherever applicable to allsizes and types of organizations oper-

ating in any sector. ISO13485 wasdeveloped by ISO Technical Commit-tee 210. ISO/TC 210 is responsible

for quality management and corre-sponding general aspects for medical

devices.

The CE marking stands for

Conformit Europenne which is aEuroepan mark of conformity indica-tion that a product or system towhich it is applied. It complies with

the applicable European laws(Directives) regulating a necessarylevel of protection with respect tosafety, health, environment and con-

sumer protection.

At ReaMetrix,

Our vision is One world One Quality.Our reagents are globally relevant andour Dry Tri T-STAT is the first CD4

enumeration reagent in a dried- downformat to have US FDA clearance and

CE marking as well. All reagents atReaMetrix are manufactured using aISO9001-2008 cleared process thatensures the highest international stan-

dards of quality.

In fact, our robust quality control fol-lows all through the manufacturingprocess from the optimum selection ofthe right dye molecules and antibodies

(with the highest affinity, the right

dye to protein ratio and the right com-

bination of antibody concentrations

required to achieve saturated labeling

for the cell count range in the sample)to the dried-down labeled product thatreaches the customer. QA/QC is verywell regulated over many batches pre-

venting the batch to batch variabilityand thus providing ease of perform-

ance to the customers.

To know more about our quality re-

agents please visit,

www.reametrix.com


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If you would like to discontinue receiving this communication please write to readigest@reametri

Commitment to Quality at ReaMetrix

Reametrix brings in the vision of quality,

affordable diagnostics without compro-mising on science. We follow a gooddocumentation system and customermanagement cell which caters the needs

of the customers in a very efficientway. Our commitment to provide quality

diagnostic reagents is reflected in everysuccessful project that we are part of,

like the one with FIND

We partner with,

FIND malaria program in collaboration

with WHO. The program necessitateshigh quality diagnosis and reportingof incidence rates in order to determinewhich interventions are working effec-tively and how much malaria is still

around.

Ensuring accurate diagnosis saves lives

by guiding correct treatment, and dem-onstrating accuracy gives both healthworkers and patients the assurancenecessary to base treatment on therapid diagnostic tests (RDT) result. Lackof confidence in results is a major im-pediment to current RDT-based pro-

grams.

It is vital that RDT quality can bechecked and assured at the level oftheir use. We are working with FIND todevelop stable positive control wells formalarial RDTs. When available, these

will provide a simple, low-cost method to

We at Reametrix,

believe that process control is a criti-cal component of generating highquality data and products. Our corpo-rate infrastructure is process-

centric, and we live by our philosophy

on a daily basis. Rigorous documenta-tion, full audit trails, and a dedicatedquality group result in high qualityproducts, and reproducible, trustwor-thy data. At ReaMetrix, Process isour Product. Our primary focus is toapply Six Sigma product development

strategies to diagnostic and life sci-

ence products.

In addition to quality, process controlcan be applied to cost management.With a robust and repeatable proce-

dure it is possible to optimize theselection of dyes to include newercandidates free of intellectual prop-

erty constraints.

test and ensure that quality can be

monitored from manufacture to the

end-user.

For more information on FIND malaria

program please visit

www.finddiagnostics.org

Some Highlights

Six Sigma Product DevelopmentStrategies

Full Audit trails for product develop-ment and contract research projects

GMP level manufacturing processes

ISO 9001 2008 Certified

wishing you all “a very happy new

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