Maximum flexibility for research, optimization and production

研究，優(yōu)化和生產(chǎn)的最大靈活性

Software designed for 21CFR part 11 compliance

Enabling traceability through audit trail and reporting functions for efficient reviews
User management including password management support and login rules
Electronic signature in compliance with 21 CFR Part 11 

軟件設(shè)計為21CFR第11部分合規(guī)  

啟用可追溯性通過審計跟蹤和報告功能，以便進行有效的審查。
用戶管理，包括密碼管理支持和登錄規(guī)則
電子簽名符合21 CFR Part 11

Symphony? X

MULTIPLEX   PEPTIDE  SYNTHESIZER

多路復(fù)用多肽合成儀

Purity
Productivity
Power

純度
生產(chǎn)力
能力

Enabling Traceability

實現(xiàn)可追溯性

Symphony? X instruments in cGMP facilities are used for synthesis of peptides required in applications, such as clinical studies and neoantigen trials as well as cosmetic formulations. For instrumentation in these environments, safe and accurate data storage and traceability are required. Regulatory agencies such as the United States Food and Drug Administration (FDA) and European Medicines Agency require certain controls and documentation for software involved in the processing of electronic data. Title 21 

CFR Part 11 is the part of the Code of Federal Regulations that establishes FDA regulations on electronic records and electronic signatures, while EU Annex 11 provides similar guidance in Europe. 

Symphony?X儀器在cGMP設(shè)施中用于合成應(yīng)用所需的多肽，如臨床研究和新抗原試驗以及化妝品配方。 對于這些環(huán)境中的儀器，需要安全準(zhǔn)確的數(shù)據(jù)存儲和可追溯性。 監(jiān)管機構(gòu)如美國食品和藥物管理局(FDA)和歐洲藥品管理局要求對涉及處理電子數(shù)據(jù)的軟件進行某些控制和文檔。 標(biāo)題21 CFR Part 11是聯(lián)邦法規(guī)法典的一部分，建立了FDA關(guān)于電子記錄和電子簽名的法規(guī)，而EU Annex 11在歐洲提供了類似的指導(dǎo)。  

To help address these requirements, Symphony X software includes features that enable traceability via the following functions, for efficient reviews:

User Management

Audit Trail

Data Integrity

Electronic Signatures

為了幫助解決這些需求，Symphony X軟件包含了通過以下功能來實現(xiàn)可追溯性的功能，以便進行有效的審查:  

用戶管理  

審計跟蹤  

數(shù)據(jù)完整性  

電子簽名

21 CFR part 11 compliance and IQ/OQ

In combination with training by qualified personnel, a comprehensive quality management system, and appropriate documentation including Installation Qualification and Operation Qualification (IQ/OQ), software designed for 21 CFR Part 11 compliance helps Symphony X users meet and exceed regulatory standards.

IQ/OQ support services verify and document that your instrument is supplied, installed, and operating according to GPT specifications. GPT-certified field service engineers inspect critical components, ensure that your systems function properly and reproducibly during automated synthesis operations, and provide documentation to help you meet regulatory requirements.

21 CFR part 11合規(guī)性和IQ/OQ  

通過合格人員的培訓(xùn)，全面的質(zhì)量管理體系，以及包括安裝確認(rèn)和操作確認(rèn)(IQ/OQ)在內(nèi)的適當(dāng)文檔，為21 CFR Part 11合規(guī)性設(shè)計的軟件，有助于Symphony X用戶滿足并超越監(jiān)管標(biāo)準(zhǔn)。  

IQ/OQ支持服務(wù)驗證并記錄您的儀器是否按照GPT規(guī)范提供、安裝和運行。 gpt認(rèn)證的現(xiàn)場服務(wù)工程師檢查關(guān)鍵部件，確保您的系統(tǒng)在自動化合成操作過程中正常運行并可重復(fù)使用，并提供文檔幫助您滿足法規(guī)要求。 

User Management

用戶管理

Administrators can configure passwords by defining password length, complexity, frequency of change, and exclusion of used passwords. Administrators may also define the maximum number of failed login attempts. After a specified (and configurable) period of inactivity, users are automatically logged out and must re-enter a password to log in to the software. 

At a minimum, a password is required when creating a new or editing an existing program or sequence file. Beyond this, more stringent controls can be assigned by administrators.

管理員可以通過定義密碼長度、復(fù)雜度、修改頻率和已使用密碼的排除情況來配置密碼。 管理員還可以定義登錄失敗的最大次數(shù)。 在指定的(可配置的)不活動時間后，用戶將自動注銷，必須重新輸入密碼才能登錄軟件。  

創(chuàng)建新程序或編輯現(xiàn)有程序或序列文件時，至少需要密碼。 除此之外，管理員還可以分配更嚴(yán)格的控制。

Audit Trail

An audit trail is a time-stamped, modification-protected electronic data file detailing all system events and record modifications. Symphony X software allows a user or auditor to view synthesis run reports, instrument activity log files, user activity log files, and software log files. It is possible to export and print the full contents of all records including the audit trail.

Detailed records of user and software activity as well as data from internal sensors monitoring fluid deliveries, heating, etc. also make these files useful diagnostics for instrument performance and troubleshooting. 

審計跟蹤  

審計追蹤是一個有時間戳和修改保護的電子數(shù)據(jù)文件，詳細(xì)說明了所有系統(tǒng)事件和記錄修改。 Symphony X軟件允許用戶或?qū)徍藛T查看綜合運行報告、儀器活動日志文件、用戶活動日志文件和軟件日志文件。 可以導(dǎo)出和打印所有記錄的完整內(nèi)容，包括審計跟蹤。  

用戶和軟件活動的詳細(xì)記錄以及內(nèi)部傳感器監(jiān)測流體輸送、加熱等數(shù)據(jù)，也使這些文件對儀器性能和故障排除有用的診斷。

Data Integrity

Synthesis program, cleavage, and sequence files are protected and encrypted by document passwords and recorded as digitally signed PDFs using PDFTron technology.

A backup, archiving and recovery strategy is necessary in order to ensure that the reconstruction of data is achievable in the unexpected event of data loss. Symphony X software allows users to create a backup (restore point) on local or external drives, from which they can effectively restore the software.  

數(shù)據(jù)完整性  

合成程序、解法和序列文件由文檔密碼保護和加密，并使用PDFTron技術(shù)記錄為數(shù)字簽名的pdf文件。  

備份、歸檔和恢復(fù)策略是必要的，以確保在數(shù)據(jù)丟失的意外事件中可以實現(xiàn)數(shù)據(jù)重構(gòu)。 Symphony X軟件允許用戶在本地或外部驅(qū)動器上創(chuàng)建備份(恢復(fù)點)，從而有效地恢復(fù)軟件。
  

Electronic Signatures

Electronic signatures function in the same fashion as hand-written signatures. To meet FDA requirements regarding the use of electronic signatures, the software must employ at least two distinct identification components such as an identification code and password. When a new user is added to the system, they are confirmed to have a unique username, username-password combination, email, and legal name that is used for Digital Signatures.

Completed synthesis runs are signed off by the user who initiated the synthesis. This is manifested in the synthesis run report as a digital signature. Signed synthesis reports contain the printed name of the signer, date, time when the signature was executed, and the reason for signing. 

電子簽名  

電子簽名的功能與手寫簽名相同。 為了滿足FDA關(guān)于使用電子簽名的要求，軟件必須使用至少兩個不同的識別組件，如識別代碼和密碼。 當(dāng)添加新用戶時，需要確認(rèn)新用戶的用戶名、用戶名和密碼的組合、電子郵件和“數(shù)字簽名”的合法名稱是唯一的。  

完成的合成運行由發(fā)起合成的用戶簽字。 這在綜合運行報告中表現(xiàn)為數(shù)字簽名。 簽名的綜合報告包含簽名者的打印姓名、日期、執(zhí)行簽名的時間和簽署的原因。  

Audit Support Documentation

In addition to training records, feature, and user guides, an audit support document can be provided that explains in detail how individual software features align with the specific requirements outlined in 21 CFR Part 11. 

審計支持文檔  

除了培訓(xùn)記錄、特性和用戶指南之外，還可以提供審計支持文檔，詳細(xì)解釋單個軟件特性如何與21 CFR第11部分中概述的特定需求保持一致。 

Symphony X

SYSTEM SPECIFICATIONS系統(tǒng)規(guī)范  

Number of reaction vessels：24 (12 with pre-activation)

反應(yīng)容器數(shù)量:24個(預(yù)激活12個) 

Synthesis scale range：0.005* mmol - 24 mmol (up to ~2 g of resin per RV) *minimum deliveries 1 mL or 0.5 mL with Single-Shot

合成規(guī)模范圍:0.005* mmol - 24 mmol(每RV可達2 g樹脂)*最小交付1 mL或0.5 mL單次注射

Reaction vessel volume：Plastic, disposable - 10 mL, 45 mL；Borosilicate glass - 10 mL, 40 mL

反應(yīng)容器體積:塑料，一次性- 10ml, 45ml;硼硅酸鹽玻璃- 10ml, 40ml

Number of solvent positions：1 primary solvent, 20 L capacity. Other sizes available

7 user-defined solvent positions, 0.5 L - 4 L capacities. Other sizes available

溶劑位置數(shù):一次溶劑1個，容量20l。 其他尺寸  

7個用戶定義的溶劑位置，0.5 L - 4l容量。 其他尺寸

Number of amino acid positions：Up to 40 amino acid positions 10 mL, 120 mL and 400 mL bottles

氨基酸位置數(shù)量:多達40個氨基酸位置10毫升，120毫升和400毫升瓶 

Chemistries supported：Fmoc, t-Boc, organic, peptoid, combinatorial, branched, PNA

支持的化學(xué):Fmoc, t-Boc，有機，類肽，組合，分支，PNA

Activation：DIC/HOBt, DIC/OxymaPure, HBTU, HATU, HCTU, TBTU, PyBOP and others

激活:DIC/HOBt、DIC/OxymaPure、HBTU、HATU、HCTU、TBTU、PyBOP等

Throughput：User defined

處理量:用戶定義的

Fluid transfer method：Positive pressure with nitrogen

流體輸送方法:正壓氮氣輸送

Agitation method：Nitrogen bubbling and/or oscillation mixing can be adjustable and programmable

攪拌方式:氮氣鼓泡和/或振蕩攪拌可調(diào)可編程

Otional heating method：Induction heating with IR pyrometer temperature sensinge

加熱方式:感應(yīng)加熱，采用紅外高溫計測溫

Cleavage：Automatic, programmable (for Fmoc chemistry only) 

切割:自動，可編程(僅適用于Fmoc化學(xué)) 

Waste container：(2) 20 L D.O.T rated containers  with over-flow sensor in cap

廢物容器:(2)20升的運輸量額定容器，瓶蓋上有溢出傳感器

Reporting：Real-time log file updated for every instrument function, print to external file, pull up on screen or printer

報告:實時日志文件更新每一個儀器功能，打印到外部文件，拉上屏幕或打印機

Power：115 V/60 Hz or 230 V/50 Hz

功率：115 V/60 Hz or 230 V/50 Hz

Dimensions：45”W, 29”D, 66”H (114 cm W, 74 cm D, 168 cm H)

尺寸：45”W, 29”D, 66”H (114 cm W, 74 cm D, 168 cm H)

Weight：550 lbs. (250 kg)

重量:550磅(250公斤)

Warranty：One year, parts and labor

保修:一年，包括配件和人工

Optional：Infrared (IR) Heating UV monitoring

可選:紅外(IR)加熱紫外監(jiān)測