Introduction to PBSPharmaBioSolutions (PBS) is a UK based company. It also has an office in Beijing. PBS operation in Beijing has been registered as a WOFE (Wholly Owned Foreign Enterprise) with the Beijing authority and has all the necessary licences and tax registration (including VAT) to provide its services to its clients throughout China.法瑪碧歐是家英國(guó)公司，在北京有其辦公場(chǎng)所。北京法瑪碧歐是北京市授權(quán)的外商獨(dú)資公司，具有所有必須的執(zhí)照和稅務(wù)登記（包括增值稅），為其中國(guó)的客戶提供服務(wù)。 PBS team of highly experienced European consultants have on average 20 years experience covering all aspects of qualification and validation for EMEA, and US FDA. They have worked with most of major international companies in various plants around the world.法瑪碧歐團(tuán)隊(duì)的歐洲顧問有平均超過20年以上的經(jīng)驗(yàn)，包括了所有各種EMEA和美國(guó)FDA的確認(rèn)及驗(yàn)證。他們工作遍布世界各國(guó)際大公司。 To provide a high quality but cost effective solution to its clients in China, PBS project team includes both European and Chinese engineers. 為向中國(guó)客戶提供高質(zhì)量并且低成本的解決方案，法瑪碧歐項(xiàng)目團(tuán)隊(duì)即包括歐洲也包括中國(guó)工程師。 PBS Engineers have been working on all aspects of Pharmaceutical and Biotechnology manufacturing production including:法瑪碧歐工程師致力工作于制藥和生物技術(shù)生產(chǎn)各個(gè)方面，包括：? API manufacturing (Lab, Pilot, full production)? 原料藥生產(chǎn)（實(shí)驗(yàn)室，中試，完整生產(chǎn)）? Biotech manufacturing (Bioreactors, preparation, purification, etc)? 生物技術(shù)生產(chǎn)（反應(yīng)罐，配料，純化等）? Finishing processes (solid dose, parental, etc)? 成品工藝（固體制劑，注射制劑等）? Cleaning and Sterilisation (CIP/SIP)? 清洗與滅菌（在線清洗/在線滅菌）? HVAC including Building Management systems (BMS) & Environmental Monitoring Systems (EMS)? 空調(diào)暖通包括樓宇管理系統(tǒng)（BMS)和環(huán)境監(jiān)測(cè)系統(tǒng)（EMS)? Utilities: Water (Purified, WFI), clean steam, clean air, gases, etc? 公用工程：水系統(tǒng)（純化水，注射用水），潔凈蒸汽，潔凈空氣，其它氣體等 PBS Automation team with their vast experience in implementation of Automation solution for pharmaceutical industry globally can provide advice and support in defining their requirement and creating URS具有全球制藥行業(yè)自動(dòng)化解決方案的豐富經(jīng)驗(yàn)的法瑪碧歐自控團(tuán)隊(duì)，可以在其需要以及創(chuàng)建URS時(shí)提供建議和支持。 Global standards such as ISA-S88 (IEC 61512), S95 are extensively used as the bases for the definition and design of automation systems. A vast majority of systems provided by PBS have been designed to satisfy 21 CFR Part11 Electronic Records & Electronics Signatures.國(guó)際標(biāo)準(zhǔn)比如ISA-S88 (IEC 61512), S95在定義和設(shè)計(jì)自控系統(tǒng)過程中被廣泛使用。由法瑪碧歐提供的大部分系統(tǒng)均滿足21 CFR Part 11電子記錄和電子簽名。 Systems supplied by PBS have been implemented following GAMP guidelines and have successfully passed EMEA and US FDA inspections法瑪碧歐提供的系統(tǒng)已經(jīng)根據(jù)GAMP指南執(zhí)行并且成功的通過了EMEA和美國(guó)FDA的檢查。PBS can provides turnkey Automation Systems including installation and complete validation. Its services includes法瑪碧歐可以提供自控系統(tǒng)交鑰匙工程，包括安裝和完整的認(rèn)證，服務(wù)包括有:? Feasibility studies and assistance in creating URS 可行性研究和協(xié)助創(chuàng)建URS? Assistance in Risk Assessment協(xié)助風(fēng)險(xiǎn)評(píng)估? Creating Quality Plan創(chuàng)建質(zhì)量計(jì)劃? Creating Design Documents: Functional Specification, Hardware Specification, Software Design specification, Software Module Specification創(chuàng)建設(shè)計(jì)文檔：功能規(guī)范，硬件規(guī)范，軟件設(shè)計(jì)規(guī)范，軟件模塊規(guī)范? Build Cabinets, supply of field devices 制造柜體，提供現(xiàn)場(chǎng)設(shè)備? Develop software開發(fā)軟件? Create test protocols: Factory Acceptance Test Protocol. Site Acceptance Protocol創(chuàng)建測(cè)試方案：工廠驗(yàn)收測(cè)試方案，現(xiàn)場(chǎng)驗(yàn)收方案? Execution of protocols執(zhí)行方案 As an independent supplier of Automation solution they can offer the most suitable hardware solution for your applications. We offer Automation Solutions based on any of the following hardware platforms: 作為一個(gè)獨(dú)立的自動(dòng)化解決方案供應(yīng)商，可為您的應(yīng)用提供最合適的硬件解決方案。我們可基于以下任何硬件平臺(tái)提供自動(dòng)化解決方案:? DCS systems 集散控制系統(tǒng)? PLC based systems 基于PLC的系統(tǒng)? SCADA based solutions 基于SCADA的系統(tǒng)? Data Management systems (local and plant wide) 數(shù)據(jù)管理系統(tǒng)（本地和全廠）? MES systems 制造執(zhí)行系統(tǒng)? LIMS systems 實(shí)驗(yàn)室信息管理系統(tǒng) Solutions offers include most of major brand names including: Siemens, Invensys, Rockwell, Honeywell, Schneider, ABB, Johnson Controls, etc. 提供的解決方案包括大多數(shù)主要品牌包括：西門子，英維思，羅克韋爾，霍尼韋爾，施耐德，ABB，江森控制等