GMP & 21 CFR Part 11-Ready Software


21 CFR Part 11 defines the US Food and Drug Administration’s( FDA) acceptance criteria for use of electronic records and electronic autographs as equal to paper records with handwritten autographs. Our eLeaP instruments are 21 CFR Part 11-ready; in other words, you can completely integrate single or multiple instruments into your being IT networks. You can also configure the locales where data is saved and save it ever.

You can operate the NC- View ™ and NucleoView ™ software( for the NucleoCounter ® NC- 202 ™ and NC- 3000 ™ independently), in confined mode to insure you remain biddable with 21 CFR Part 11 regulations. This means that on a computer system that’s 21 CFR Part 11 compatible, it’s possible to maintain the position of compliance during use.

Use Windows Active Directory- defined stoner groups to control druggies ’ access and rights within the NC- View ™ and NucleoView ™ software. There are three stoner groups Admin, Supervisor, and stoner. Admins have the loftiest position of boons and can switch on or off the 21 CFR Part 11- mode in the software. In comparison, administrators and druggies have further defined boons. When 21 CFR Part 11- mode is actuated, all druggies are unfit to modify data during accession and also after the data is stored.

Inspection Trail

All stoner exertion within the NC- View ™ and NucleoView ™ software programs is recorded in the event log, which can only be penetrated by druggies in the Admin group. Event log lines are translated and defended to help revision, which the software authenticates.

Results are saved in translated data lines and can snappily and fluently be exported from the software in PDF or CSV formats. You can customize where you choose to save your data and results.

NucleoCounter ® NC- 250 ™

The NucleoCounter ® NC- 250 ™ is a compact instrument for cell counting and viability, CEll Cycle and Vitality ( Apoptosis) dimension which fits impeccably in any mammalian cell laboratory performinge.g. exploration,quality control or monitoring of product. The NucleoCounter ® NC- 250 ™ is veritably simple to operate simply blend sample with reagents, cargo slide and press run.

It comes with a new advanced software package. The stoner input of voluntary dilution of a sample is directly reckoned for in the software. The protocols can be acclimated by the stoner to accommodate cell lines that are out of the ordinary.

How ChemoMetec A/ S addresses 21 CFR Part 11

This document provides guidelines on how ChemoMetec addresses 21 CFR Part 11.

The 21 CFR Part 11 regulations can only be applied when, the NucleoCounter ® NC- 250 ™ and the

NucleoView ™ NC- 250 ™ software are a unrestricted system.

Each applicable Part 11 section will be listed with number, textbook of the given part, capsule of conditions and eventually the approach taken by ChemoMetec to allow the stoner to meet the 21 CFR Part 11 regulation.

Section A – 21 CFR Part 11 Subpart B – Electronic Records

Part11.10 Controls for unrestricted systems.

Persons who use unrestricted systems to produce, modify, maintain, or transmit electronic records shall employ procedures and controls designed to insure the authenticity, integrity, and when applicable, the confidentiality of electronic records, and to insure that the signer can not readily repudiate the inked record as not genuine. similar procedures and controls shall include the following


Part11.10( a)

confirmation of systems to insure delicacy, trustability, harmonious intended performance, and the capability to discern invalid or altered records. insure the system can descry invalid or altered records.

Data lines can not be altered from within the NucleoView ™ NC- 250 ™ software. fresh information can still be included in the data lines, which latterly are pronounced.

The validity of data lines are controlled via an internal checksum.

For lab- position confirmation, specific support can be handed by external cooperation mates.

Part11.10( b)

The capability to induce accurate and complete clones of records in both mortal readable and electronic forms suitable for examination, review, and copying by agency. Persons should communicate the agency if there are any questions regarding the capability of the agency to perform similar review and copying of the electronic records. induce accurate records in mortal readable and electronic form

For examination, review and dupe by agency all results can be published directly from the NucleoView ™ NC250 ™ software to the dereliction printer only.

The dereliction printer can not be a train printer.

All records can also be exported to other train formats including FCS and ACS and copied directly to clipboard to paste into other software.

ChemoMetec A/ S holds no responsibility for the farther running of exported or copied data.

All acquired data lines are saved in our own. CM train format conforming of the raw image data, the calculated results and the complete settings with which the data was acquired.

Part11.10( c)

Protection of records to enable their accurate and ready reclamation throughout the records retention period.

Enable accurate and fluently accessible reclamation of electronic records

Data lines can not be deleted from within the NucleoView ™ NC- 250 ™ software.

Archived data lines can be maintained in readily retrievable form using the combination of train waiters

and/ or databases together with a running dupe of the NucleoView ™ NC- 250 ™ software.


Part11.10( d)

Limiting system access to authorized individualities.

Differential access to use the NucleoCounter ® NC- 250 ™ system

Access control to the NucleoCounter ® NC- 250 ™ system relies on Windows ACL to assign individualities to different stoner groups.

Only individualities belonging to system directors, “ NucleoViewAdmin ”, ” NucleoViewSuperVisor ” and

“ NucleoViewUser ” stoner groups can pierce the NucleoView ™ NC- 250 ™ software.

Part11.10( e)

Use of secure, computer- generated time- stamped inspection trails to singly record the data and time of driver entries and conduct that produce, modify, or cancel electronic records. Record changes shall not obscure former listed information. similar inspection trail attestation shall be retained for a period at least as that needed for the subject electronic records and shall be available for agency review and copying.

insure inspection trail for all conduct made by the stoner, and that no records are deleted

A time- stamped Event Log automatically and continuously records all conduct made by the stoner.

It isn’t possible from within the NucleoView ™ NC- 250 ™ software obscure or delete data, only adding of

commentary to the gathered data is possible.

The event log contains information on date, time, stoner name, full name, sphere of computer, periodical number of eLeaP used along with type of action performed.

For each data train the stoner name and full name is recorded along with the periodical number of the


Any fresh information entered in a data train will be logged inside that date train with stoner name and time stamp, and thereby complies to the total retention period.

Archived Event Log lines are mortal readable using any standard textbook editor, and can be maintained in readily retrievable form using the combination of train waiters and/ or databases.

Part11.10( f)

Use of functional system checks to apply permitted sequencing of way and events, as applicable.

Control the right sequence of way and events

The NucleoCounter ® NC- 250  system is a completely automated system, and validated to insure that all gathering of data follows a predefined sequence defined in the protocol of the software.

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