코로나19(COVID-19) 대응 - 팬데믹 기간 중 백신 및 치료제 관련 연구를 위한 지원을 아끼지 않고 있습니다. 자세히 알아보기 

FDA 21 CFR Part 11와 EudraLex Annex 11소프트웨어 Validation을 통해 규정 준수를 달성합니다.

 

SoftMax® Pro 7.1.2 GxP 소프트웨어는 데이터 무결성을 보장하기 위한 간소화된 실험과정을 바탕으로 완벽한 FDA 21 CFR Part 11와 EudraLex Annex 11 규정 준수를 달성할 수 있는 가장 안전한 최신의 소프트웨어입니다. 모든 진행 단계는, 분석 및 보고를 간소화하여 당사 Microplate Reader를 지원하는 데 최적화되었습니다.

전문가로 이루어진 우리 팀과 고객사가 함께 협력하여 단일 혹은 또는 Enterprise Level의 소프트웨어를 세팅하고, 고객의 Microplate Reader에 대한 완벽한 Compliance를 확립하기 위해 Validation Package를 사용하여 IQ OQ 서비스를 제공합니다. 주요 데이터의 개인정보 보호 및 보안 개선 사항을 통해 최신 GDPR 규정을 지원합니다.

SoftMax Pro GxP Compliance 소프트웨어가 21 CFR Part 11와 EU GMP Annex 11 요구사항을 어떻게 충족하는지 살펴보세요.

  • 모든 변경 사항 추적 및 기록

    모든 변경 사항 추적 및 기록

    시스템 감사 추적을 통해 날짜 및 시간 스탬프, 사용자 이름, 사용자 ID, 섹션 진술, 서명 정보 및 판독 결과 등의 모든 변경 사항을 추적할 수 있습니다.

  • 데이터 무결성 유지

    데이터 무결성 유지

    종이를 사용하지 않는 문서 현황 시스템은 전자서명과 문서 워크플로를 제어하는 데이터 무결성을 유지합니다. 프로젝트 팀은 문서를 추적하는 동시에 제어된 환경에서 개발, 검토, 공개 및 사용 과정을 거쳐 이동할 수 있습니다.

SoftMax Pro 7.1 GxP 소프트웨어

GxP Compliance 소프트웨어 기능

  • 프로토콜 아이콘

    Windows Active Directory

    Windows Active Directory 또는 GxP 관리자 소프트웨어를 통한 사용자 관리는 암호 기준, 재설정 및 변경 기간의 정의 과정을 간소화하고 IT 지원의 양을 줄여 줍니다.

  • 기능성 개선 아이콘

    자동 저장 기능 개선

    새로운 문서는 저장해야 수정할 수 있으며, 문서는 데이터 손실을 방지하기 위해 판독 전후에 자동으로 저장됩니다.

  • 서명 개선 아이콘

    서명 프로세스 개선

    사용자는 문서당 하나의 공개 전후 진술에만 서명할 수 있는데 이는 데이터 무결성을 지키는 데 도움이 됩니다.

  • 프로젝트 아이콘

    프로젝트 기능

    사용자가 다양한 역할로 다양한 프로젝트에 할당될 수 있지만 동일한 프로젝트에서 서로 다른 역할을 가질 수 없는 경우 프로젝트 팀이 생성될 수 있습니다.

  • 역할과 권한 아이콘

    역할 및 권한

    권한은 역할별로 정의되며 이에 따라 프로젝트 내의 사용자에게 할당되어 구조화된 시스템을 유지합니다. 세 가지의 사전 정의 역할, 즉 과학자, 실험실 관리자, 실험실 기술자는 문서 공개 워크플로에 편의를 제공하여 처음 사용하는 사람들이 신속하게 시작할 수 있게 합니다.

  • Validation 아이콘

    자동 내보내기 기능

    데이터는 데이터베이스 외부의 위치로 내보내질 수 있으며 다양한 파일 형식을 사용할 수 있어 LIMS(Laboratory Information Management System) 또는 SDMS(Scientific Data Management System)와 같은 다른 응용 분야로의 가져오기를 지원할 수 있습니다. XML은 데이터 내보내기 및 자동 내보내기에 대해 지원됩니다.

신뢰도와 함께 데이터 무결성과 규정 준수를 보장합니다.

실험실 인증 준수를 위한 빠르고 신뢰도 높은 설치와 세팅을 위해, 검증된 GMP/GLP 실험실 Compliance Solution으로 구성된 제품군을 제공합니다.

  • 업계 최고의 Microplate Reader와 Washer로 모든 Assay 요구사항을 지원합니다.
  • IQ/OQ/PM Service - Compliant Format에 맞춘 디지털 문서를 보존합니다.
  • Software Installation Service - 운영 사양에 맞게 필수 구성품이 제대로 설치되어 있는지 확인하고 문서화 합니다.
  • Software Validation Service - FDA 21 CFR Part 11와 EudraLex Annex 11 Guideline에 맞게 지원합니다.
  • Validation Plate Test - 추적 가능하고 신뢰할 수 있는 물질을 사용하여 보유하고 있는 Microplate Reader의 성능을 검증합니다.
GMP-GLP 실험실용 GxP Compliance 솔루션

 

최신 자료

33

SoftMax Pro 소프트웨어의 사양 및 옵션

 

유용한 팁:

  • 데이터 손실을 방지하려면 하드 디스크, CPU 및 USB 포트에 대한 모든 절전 및 최대 절전 설정을 끄십시오.
  • 자동 Windows 업데이트 비활성화
  • 소프트웨어가 기구를 사용하지 않을 때에는 Windows를 수동으로 업데이트, 이러한 옵션은 Windows 제어판에서 활성화 가능

참고: Windows XP 운영 체제에서 SoftMax Pro 소프트웨어를 설치하고 사용하는 것은 더 이상 지원되지 않습니다. 소프트웨어는 Windows XP에서 테스트 및 검증되지 않습니다.

SoftMax Pro GxP 소프트웨어 관련 자료

프레젠테이션
동영상 및 웨비나
GxP 규제 환경에서 데이터 무결성 Compliance를 준수합니다.

GxP 규제 환경에서 데이터 무결성 Compliance를 준수합니다.

GMP-GLP 실험실용 GxP Compliance 솔루션

GMP/GLP 실험실용 GxP Compliance Solution

완벽한 소프트웨어 및 Validation tool 세트

Microplate Reader를 위한 완벽한 소프트웨어 및 Validation Tool이 GMP/GLP 실험실이 FDA 데이터 무결성 가이드라인을 충족하는 데 도움이 되는 방법

SoftMax Pro 7.1 GxP 소프트웨어

Microplate Reader를 위한 SoftMax Pro GxP Software Compliance

  • Citation
    Dated: Apr 23, 2021
    Publication Name: Nature Protocols

    Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays

    Virus neutralization assays measure neutralizing antibodies in serum and plasma, and the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of these antibodies for many viral diseases. We have developed procedures for the standard PRNT, microneutralization assay (MNA) and pseudotyped virus… View more

    Virus neutralization assays measure neutralizing antibodies in serum and plasma, and the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of these antibodies for many viral diseases. We have developed procedures for the standard PRNT, microneutralization assay (MNA) and pseudotyped virus neutralization assay (PNA) for severe acute respiratory syndrome coronavirus 2. The MNA offers advantages over the PRNT by reducing assay time, allowing increased throughput and reducing operator workload while remaining dependent upon the use of wild-type virus. This ensures that all severe acute respiratory syndrome coronavirus 2 antigens are present, but Biosafety Level 3 facilities are required. In addition to the advantages of MNA, PNA can be performed with lower biocontainment (Biosafety Level 2 facilities) and allows for further increases in throughput. For each new vaccine, it is critical to ensure good correlation of the neutralizing activity measured using PNA against the PRNT or MNA. These assays have been used in the development and licensure of the ChAdOx1 nCoV-19 (AstraZeneca; Oxford University) and Ad26.COV2.S (Janssen) coronavirus disease 2019 vaccines and are critical for demonstrating bioequivalence of future vaccines.

    Contributors: Kevin R. Bewley, Naomi S. Coombes, Luc Gagnon, Lorna McInroy, Natalie Baker, Imam Shaik, Julien R. St-Jean, Natalie St-Amant, Karen R. Buttigieg, Holly E. Humphries, Kerry J. Godwin, Emily Brunt, Lauren Allen, Stephanie Leung, Phillip J. Brown, Elizabeth J. Penn, Kelly Thomas, Greg Kulnis, Bassam Hallis, Miles Carroll, Simon Funnell & Sue Charlton  
    Go to article

  • Citation
    Dated: Dec 15, 2020
    Publication Name: Vaccine

    Development and characterization of a standardized ELISA including a reference serum on each plate to detect antibodies induced by experimental malaria vaccines

    Enzyme linked immunosorbent assay (ELISA) has been widely used to measure antibody titers for evaluating the immunogenicity of a vaccine. However, there is as yet no generally accepted way of expressing the ELISA results in the case of experimental vaccines, since there is usually no uniform standard. Both end point and single dilution methods… View more

    Enzyme linked immunosorbent assay (ELISA) has been widely used to measure antibody titers for evaluating the immunogenicity of a vaccine. However, there is as yet no generally accepted way of expressing the ELISA results in the case of experimental vaccines, since there is usually no uniform standard. Both end point and single dilution methods have significant disadvantages. In this paper, we obtained reproducible data with fewer dilutions of samples by addition of serially diluted standard serum to each ELISA plate. Since this ELISA method gives reliable antibody titer with less labor than other methods, it can strongly support vaccine development.

    Contributors: Kazutoyo Miura, Andrew C. Orcutt, Olga V.Muratova, Louis H.Miller Allan, Saul, Carole A. Long  
    Go to article

  • Citation
    Dated: Aug 19, 2020
    Publication Name: bioRxiv

    NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways 3 against SARS-CoV-2 challenge

    There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation. View more

    There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation.

    Contributors: Mimi Guebre-Xabier, Nita Patel, Jing-Hui Tian, Bin Zhou, Sonia Maciejewski, Kristal Lam, Alyse D. Portnoff, Michael J. Massare, Matthew B. Frieman, Pedro A. Piedra, Larry Ellingsworth, Gregory Glenn, Gale Smith  
    Go to article

  • Citation
    Dated: Nov 28, 2019
    Publication Name: Springer

    Meeting technical challenges for protein characterization and surrogate equivalence studies that resulted from insecticidal protein co-expression in maize event MZIR098

    Safety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source. View more

    Safety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source.

    Contributors: Frederick S. Walters, Scott Young & Gerson Graser
     
    Go to article

  • Citation
    Dated: Jul 12, 2019
    Publication Name: Nature

    Inside out: optimization of lipid nanoparticle formulations for exterior complexation and in vivo delivery of saRNA

    Self-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it… View more

    Self-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it requires a delivery vehicle for efficient cellular uptake and degradation protection.

    Contributors: Anna K. Blakney, Paul F. McKay, Bárbara Ibarzo Yus, Yoann Aldon & Robin J. Shattock
     
    Go to article

  • Citation
    Dated: Oct 01, 2018
    Publication Name: Crop Protection

    Identification and characterization of abamectin resistance in Tetranychus urticae Koch populations from greenhouses in Turkey

    The two-spotted spider mite, Tetranychus urticae Koch is one of the most serious pests in greenhouses and has developed high resistance to many classes of acaricides rapidly. Three T. urticae populations were collected from vegetable greenhouses in Antalya and Muğla, Turkey. These populations showed high resistance levels to abamectin ranging… View more

    The two-spotted spider mite, Tetranychus urticae Koch is one of the most serious pests in greenhouses and has developed high resistance to many classes of acaricides rapidly. Three T. urticae populations were collected from vegetable greenhouses in Antalya and Muğla, Turkey. These populations showed high resistance levels to abamectin ranging between 223 and 404 fold compared to a susceptible population. The interaction of some synergists (piperonyl butoxide; PBO, diethyl maleate; DEM and S-benzyl O,O-diisopropyl phosphorothioate; IBP) with abamectin was analyzed showing possible implication of esterases in resistances in the three populations studied. The activities of esterase, glutathione S-transferase (GST) and cytochrome P450 (p450) was determined using α-naphthyl acetate, 1-chloro-2,4 dinitrobenzene (CDNB) and 7-ethoxycoumarin (7-EC) as substrates, respectively. In all field populations, esterase, glutathione S-transferase and P450 activities were higher, when compared to the susceptible population (GSS). The presence of known abamectin resistance target site mutations (G314D and G326E) on the glutamate gated chloride channels was also examined. However, no target site–resistance mutation was detected in all three populations. According to our results, detoxification enzymes, but no target site intensivity seem to play role in abamectin resistance in field T. urticae populations from Turkey.

    Contributors: Naciye Sena Çağatay, Pauline Menault, Maria Riga, John Vontas, Recep Ay  
    Go to article

  • Citation
    Dated: Apr 04, 2001
    Publication Name: Journal of Investigative Dermatology

    An Alternative Approach to Depigmentation by Soybean Extracts via Inhibition of the PAR-2 Pathway

    The protease-activated receptor 2, expressed on keratinocytes but not on melanocytes, has been ascribed functional importance in the regulation of pigmentation by phagocytosis of melanosomes. Inhibition of protease-activated receptor 2 activation by synthetic serine protease inhibitors requires keratinocyte-melanocyte contact and results in… View more

    The protease-activated receptor 2, expressed on keratinocytes but not on melanocytes, has been ascribed functional importance in the regulation of pigmentation by phagocytosis of melanosomes. Inhibition of protease-activated receptor 2 activation by synthetic serine protease inhibitors requires keratinocyte-melanocyte contact and results in depigmentation of the dark skinned Yucatan swine, suggesting a new class of depigmenting mechanism and agents. We therefore examined natural agents that could exert their effect via the protease-activated receptor 2 pathway. Here we show that soymilk and the soybean-derived serine protease inhibitors soybean trypsin inhibitor and Bowman-Birk inhibitor inhibit protease-activated receptor 2 cleavage, affect cytoskeletal and cell surface organization, and reduce keratinocyte phagocytosis. The depigmenting activity of these agents and their capability to prevent ultraviolet-induced pigmentation are demonstrated both in vitro and in vivo. These results imply that inhibition of the protease-activated receptor 2 pathway by soymilk may be used as a natural alternative to skin lightening.

    Contributors: Christine Paine, Elizabeth Sharlow, Frank Liebel, Magdalena Eisinger, StanleyShapiro, MiriSeiberg  
    Go to article

소프트웨어 및 설치 서비스

SoftMax® Pro GxP 소프트웨어: Windows 10 호환

SoftMax Pro 7 GxP 소프트웨어 제품군의 최신 버전에 포함되는 사항: 각 사용자 라이선스를 위한 3 소프트웨어 설치, GxP 관리자 소프트웨어, 소프트웨어 IO/OQ validation 패키지 DVD, 사용자 라이선스 인증서, Compliance 인증서

단일 컴퓨터 설정 다중 컴퓨터 설정
Part Number: SMP7X GXP SINGLE COMP * Part Number: SMP7X GXP SERVER *
설치 서비스
Part Number: SMPGXP-INSTALL1COMP-OS ** Part Number: SMPGXP-INSTALLSVR-OS **
Part Number: SMPGXP-INSTALLADVSVR-OS(맞춤형 서버 설치)
추가 사용자 라이선스 구입
Part Number: SMP GXP ADD Part Number: SMP GXP SVR ADD
*최소 3개의 라이선스 구입 필요
**최초 구입에만 적용