Carly: 6 Key Features

Carly is a software package supporting whole business such as regenerative medicine, cell processing and testing company. It delivers process control function to prevent the error that should no be, such as taking wrong specimens or misuse of reagents etc, on the work process which handling specimens concerning with cell culture, or genetic tests.
It supports managements from acceptance of order, work process, to delivery on a one-stop.
You can realize “visualization/easy understanding” by analyzing the data which is stored automatically during the workers work.
You can achiece Corrective And Preventive Action (CAPA) promptly, since you can easily find deviations by using Carly.
 

1. "Safe, Secure and Smart" for All of the work processes!

The system provides you the Safe, Secure and Smart environment.

Carly protects all workers against from variety of dangers on the work process, i.e.,
taking wrong specimen, contamination in the clean room, deviation from SOP(Standard Operation Procedure), etc.

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2. Strict Control of Reagents/Materials/Equipment!

Safe and Perfect Control of Reagents, Materials and Equipment By Using Carly!

This system perfectly prevent workers from misuse by using 2D-barcode as lollows.

Strage location can be set by 3 dimension
You can manage expiration date, serial number and/or lot number control about specimens, reagent and any other materials.
You can record the movement of materials into a cleanroom.
Automatic order with replenishment/order points can be made.

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3. Eliminate thoroughly about deviations of quality!

Carly Will Eliminate Quality Deviations.

Carly has the deviation control function to achieve a stable product quality.
You will have the experience of excellent traceability.
You can take Corrective Action; Preventive Action ("CAPA") promptly.

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4. Maximize the speed of whole business!

Speed Of Business Will be Improved By Carly!
Anytime, Anywhere, You Can Get The Real Time Report Promptly.

You will see the "Next Step"!

It is possible to analyze various data and information such as order receipt, production order, production report, inventory control record of specimen and reagents, billing and payment status, etc. by order, by worker, by customer or any other various aspects.
This system automatically propose the report to customers.

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5. Compliance and Security

Carly Is Considering About Compliance And Security At Any Time!

Adaptable to Medical laboratories -- Requirements for quality and competence (ISO15189).
Adaptable to Good Manufacturing Practice (GMP).
Adaptable to Electronic Records and Electronic Signature (ER/ES) Guideline.

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6. Leading-edge Technologies

We Select Devices With Emphasis On Convenience At Work Site.

We pursue convenience at work site, selecting devices assuming to use them in a clean room. We use the labels which can withstand -196 degree of Celsius. We realize the linkage with electron microscope, temperature logger, environmental monitoring system, etc.
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Case Study

“Customer’s Voice” What happens to them?


St. Luke’s
International University

Achieved improvement of the productivity and prevention of operational errors!

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They are responsible for the specimen and blood test in the Collaborative Research Laboratory of St.Luke's International University, established for the purpose of superior medial development.

The scope of the systematization is the storage location of speciments, work allocation and progress management.

They have achieved the prevention from taking wrong specimen by using barcode reader.
They use the inventory management function and control the storage location of specimens by 3 demension.

The person in charge is delighted that they can manage from various viewpoints and pperational mistakes have drastically decreased.



National Cancer Center Japan

Their deciding factors were “Low-Cost” and “Speed of Introduction”.

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Users are the research institute in the National Cancer Center Japan, the largest research institute of cancer in Japan. They have achieved tot systematize purchase order processes.

The person in charge is delighted that they succeeded in improving the efficiency of their purchase order operation, e.g. sending purchase order via Email.

They told that their main deciding factor was the speed of introduction.


PIRM Co., Ltd
(KOHJIN BIO Co., Ltd)

The coverage of the business domain has been effective for the launch of their CPC.

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They develop a business as a start-up company in cancer immune cells industry, a region of regenerative medicine.

They introduced our system at CPC (Cell Processing Center), and suceeded in systematizing the management of cell culture process and quality control process.

Now, they can do many things prevent misidentification of specimens, degitaze manufacturing order to keep a cleanroom paperless by using tablets , analyze deviations of quality from outstanding traceability.

The person in charge told us that they utilize various functions of our system, and they could have various effects after introduction.

This system allowed as a good manufacturing management system at the time of the submission to the Japanese government of the thirt type of cell processing production and provision plan at the cell processing facility.

 

FAQ

Followings are the questions frequently asked by customers is summarized.

What is the purpose to use this system?

In regenerative medicine, cell therapy, genetic testing, etc., workers are engaged in manufacture (cell preparation) or inspection of cells for therapeutic purpose from patient's cells or tissues, generally in strictly controlled hygiene condition.

At that time, it is not permitted to misidentify the specimen, therefore, it is necessary to comply with strict process, accurate record of results, and preparation of regulatoruy compliant document.

No matter how careful they are, the errors or mistakes will occur in the manual operation.

Carly comprehensively systemized these tasks, and is used for the purpose of preventing misidentificaction of specimens, wrong work process, etc.

How can we prevent taking wrong specimens?

First, put a barcode label on a specimen.
Then using barcode reader, read a barcode label on each speciment at work process.
If a worker takes wrong specimen, Carly issues an alert and he/she cannot record the result of work process any more.

At a result, we can say "you cannot take wrong specimen".

How can we prevent divergence from SOP?

Register manufacturing process or quality inspection process as multiple tasks into system as master data (Protocol Master) for each order type. The number of processes is unlimited.

Carly automatically proposes the timeline of working process ,when the worker begins production.

According to such proposal, the worker checks the current and next step or procedure, and record the result of the task by using tablet.

It is possible for Carly not to allow the worker to proceed to the next task until he/she completes the current task.

That is how you can prevent divergence from SOP.

Why can Carly's user can conform with ISO15189, GMP and ER/ES Guideline?

Under GMP, is is required to manufacture subject to the Standard Operation Procedure, Is is also required to register and record the result thereof.
Likewise, ISO15189 requires the preparation and operation of procedure manual, manufacturing order, report, work dialy, etc.

Carly issues SOP based on the procedure manual defined for each order type, and show it to workers.
Workers proceed the tasks in accordance with the SOP.
During the work process, the workers using barcode reader, confirm the correctness of specimens and materials, and register the result of such task into the system.
Since this mechanism is equqipped, Carly ensures compliance with the procedure based on manufacturing order. That is why Carly's user can conform with GMP.


In addition, users can prepare the work diary immediately, because the result of each task as well as the beginning and ending times are recorded simultaneously with doing task.
The reports are prepared consistently with the result.

Only an authorized user, verified by ID and password, is allowed to register this system based on ER/ES Guideline.
When a user create or update the data, Carly electrically record (ER) the audit trail with timestamp automatically.

Carly adopt non-bio metric method as electric signature (ES), based on ID and controlled encrypted password for each individual.

How dose it realize traceability?

You can trace and manage the information registered on the work record, e.g., worker's name, operation time, operation result, materials information including (lot number, serial number, and expiry date), revision history, etc.

Carly automatically prepares the required documents such as manufacturing report based on production records.
This is how Carly relizes an outstanding traceability.

What is the difference with other systems?

1. Easy to add or modify the functions
Taking advantage of strength of in-house developed software, we can flexibly deal with the addition or modification of functions to changing regulations, systemization of customer's own operation, etc.

2. Globalization
Carly conform with multi-language, multi-currency, and multi-GAAP, therefore, you can use in not only in Japan, but also overseas.
You can remote access and use the system in Japan from oversea, and vice versa.

3. Advanced security
Carly provides advanced security functions for compliance with ISO15189, GMP , etc. Which includes access control by each role, revision history by each field, etc.

4. Accelerate speed of whole business
Carly provides the functions for acceleration speed of your whole business, such as cost calculation from working hours and used reagents, ordering materials, issuing invoice, etc.

Flow Of Introduction – 5days at the shortest

The flow of introduction is as follows:

Carly is a software package which achieves “Low-Cost” and “Speedy (5days at the shortest) Introduction”. Only you need to do is install it on premise/cloud server and set master data thereon.
We will also support customization tailored to your own operations, taking advantage of strenghth of in-house software.
Please feel free to contact us from the inquiry of this site first.

Step1. Contact us!
First of all, please contact us! We will ask you about the situation, schedule, etc.
Step2. Application of Carly and Implementation Support Service
We will propose you most appropriate plan based on the interview.
Step3. Implementation
We will construct an environment, according to your situation, and support implementation.
Step4. Start Using
Please experience the wonderfulness of safety and security by systematization.