5.3.4 M-Trend

顾永强

M-Trend is designed to query the archived point samples, stored in the database on the  Data / Web Server, and display the query results in both graphical and textual formats.  M-Trend allows users, with the proper authorization, to create and save trend documents containing query and display characteristics for future reference.
Each M-Trend document consists of up to 32 Data Source chosen by the user from a pool of all available archived data stored within the database.  A date/time range may be chosen for the display of data, and the user can manipulate the appearance of data, both in the graphical (only the first 6 would be displayed graphically) and textual formats.
You can select options to display what subset are shown such as Data Source Name, Data Source Description, Units, Time Offset, All Data, Average, Maximum, Minimum, and Range.

顾永强

The MVE software programs communicate and interact with the field hardware through OLE for Process Control (OPC).  All hardware devices (controllers, SAES, SAOS, and  Data center components) and objects (field points, combination of field points, control processes) are identified by a tag name. The tag name is comprised of a network name, system name, and object name. All objects are unique within the system. Every system is unique within a network and belongs to single Network Control Module (NCM). In case of multiple networks, the network name must be unique. These rules are enforced by the Metasys software package and yield a unique tag name for reference.

顾永强

Implementing MVE requires configuration of several different components in order to read, write, and access data collected from the BAS.  The logic can be broken down into three major components: collection, storage, and retrieval/reporting.

顾永强

2.        Complete all steps in each test script and print objective observed results in the Actual Results column. If the Actual Results column contains bolded text items, document the value for each item.

红茶.

不要一次性发这么多帖子；能在一贴搞定的不要发N帖。

顾永强

Upon failure of the one system (SA-AHU-01/ EA-AHU-01), the remaining system (SA-AHU-02/ EA-AHU-02) will provide back-up supply and exhaust air for all areas.  Emergency operation (AHU 1 failure/off, AHU 2 on): Bypass damper open. The pre-set positions in emergency mode need to be figured put during the balancing of the system, and can be adjusted in PMI; A manual command from the operator is required to return the defective system to normal operation.

顾永强

请将资料寄至：
Food and Drug Administration
Forensic Chemistry Center (HFR-MA500)
Bulk Drug Group
1141 Central Parkway
Cincinnati, Ohio 45202
Tel: (513) 684-3505 (Extension 184)
Fax: (513) 684-6082
建议用特快专递。
1.企业名称，中央文件编号，街道地址。
2.完整的电话和传真号码
3联系人及其头衔
4. API清单，常规批大小和每年运到美国的数量。
5. 批号编制注释
6.描述准备销往美国的原料药的包装分口系统，因为销往国内的包装是不同的。
a)描述容器的尺寸。如果容器是塑料的，列出其颜色。该容器的底和盖是什么成分的？
b)描述封口系统的尺寸或给其拍照，附上样品（如可能）。如果盖子是用波纹封条密封的吗？如果是，简要公司代码描述简要描述封条，且其是否由独特的标识符号。某些公司在波纹封铅封上有可见的产品和/或公司代码。
c)简要描述内包材或给其拍照（双层或单层塑料袋）及内层袋的封口方式。
d) 如果容易得到的话，对每一种出口的API提供一份实际标签的样张。自1991年来该标签设计有变更吗？如果有变更，简要描述。该贴签或包装含有任何独特的标识吗（即，内含的水印）
e) 给每批产品提供一份检验证书(COA)。自1991年来COA有变更吗？如果有变更，简要描述或提供一份样张。另外，还要对生成该检验证书的计算机系统的描述以及该企业采取的能避免员工误操作保证计算机数据完整性的预防措施。

顾永强

参考资料或指南
1. FDA化学原料药检查指南，1994年5月重新编排并作了少量的更改，1991年9月。
2. FDA无菌原料药生产企业检查指南，1994年7月。
3. FDA生物技术检查指南，1994年11月。
4. FDA关于原料药申请呈报支持性文件指南，1987年2月。
5. FDA执法程序指南，8-10章
6. FDA法律事务办公室警告信索引指南，1994年10月
7. GWQAP手册，第十五章，1991年修订。
8. 药品生产检查符合性程序，CP 7356.002

孙艳红

参考资料或指南
1. FDA化学原料药检查指南，1994年5月重新编排并作了少量的更改，1991年9月。
2. FDA无菌 ...[/quote]
我想知道什么意思？

syhorchid

为什么要搞成许多小豆腐块上传？为了多赚积分吗？