来源：北京齐力佳整理
OMCL Network of the Council of Europe
QUALITY ASSURANCE DOCUMENT
PA/PH/OMCL (08) 87 2R
VALIDATION OF COMPUTERISED SYSTEMS
计算机化系统的验证
ANNEX 1: VALIDATION OF COMPUTERISED CALCULATIONSYSTEMS: EXAMPLE OF VALIDATION OF IN-HOUSE SOFTWARE
附件1：计算机化计算系统的验证：自主开发软件的验证举例
INTRODUCTION 介绍
The present document is the 1st Annex of the coredocument “Validation of Computerised Systems”, and it should be used incombination with it when planning, performing and documenting the validationprocess of computerised systems.
本文件是核心文件 “计算机化系统的验证”的第一个附件。在计划、实施和记录计算机化系统验证过程时，本文件应与核心文件结合使用。
The core document contains the Introduction, Scope andgeneral requirements for the validation of different types of computerisedsystems.
核心文件包括了不同计算机化系统验证的介绍、范围和一般要求。
This Annex presents an example of Excel? spreadsheetvalidation, which is to be used in combination with the general recommendationsgiven in the core document.
本附件给出了一个EXCEL表格验证的例子，它可以与核心文件中给出的通用性推荐结合使用。
This document should be considered as a guide to OMCLsfor planning, performing and documenting the validation of their computerisedsystems. It should not be taken as a list of compulsory requirements. It isleft to the professional judgement and background experience of each OMCL todecide on the most relevant procedures to be undertaken in order to giveevidence that their computerised systems are working properly and areappropriate for their intended use.
本文件应作为OMCL在计划、实施和记录其计算机化系统时的指南。它不应被当成一个强制的要求。各OMCL应根据其专家的判断和背景经验来决定其需要执行的最相关的程序，以提供证据来证明来计算机化系统工作正常，适用于其既定的用途。
1. SOFTWARE PRESENTATION AND GENERAL INFORMATION 软件说明和一般信息
This software’s aim is to calculate a vaccinetitration (Figure 1). From results obtained for a reference product (heightmeasured at 4 concentrations), a calibration curve and its formula areprovided. Both of them are needed to calculate the concentrations correspondingto the height measured for the tested vaccine.
这个软件的目的是计算一个疫苗的滴定（图1）。从一个对照产品（在4个浓度测得的高度）得到的结果，绘制一个校正曲线并计算出一个公式。这两者均需要计算浓度和对应被检测的疫苗所得的高度。
Figure 1. Softwarepresentation软件展示
In Figure 1, grey cells are filled with numerical datafrom experimentation and are the only ones that can be changed by the operator.All cells including formula are locked. No more than one cell from thecalibration range can be empty; all cells for vaccines must be filled toguarantee proper use.
在图一中，灰色单元格填充了试验所得数字数据，仅这些单元格可以由操作者更改。所有单元格，包括公式被锁定。校正范围内不超过一个单元格可以为空，所有疫苗用的单元格应进行填充以保证适当使用。
To access the software, a password is needed to log onthe computer.
应设置登录计算机的密码，以限制进入软件。
Back ups are regularly performed to ensure originalfiles preserving.
应定期进行备份以保证原始文件的保存。
2. VALIDATION STAGES 验证阶段
The different stages of the validation are: 验证的不同阶段为
2.1 Printing of formulas公式打印
2.2 Validation of the calculations 计算验证
2.3 Validation certificate验证证书
2.4 Software installation and documentation 安装软件和记录
2.1 Printing of formulas 公式打印
In order to validate the Excel spreadsheet, formulasare printed, and the print is kept in the software validation file (Figures 2.1and 2.2).
为了验证EXCEL表格，要把公式打印出来，打印的文件要保存在验证文件里（图2.1和2.2）
Figure2.1. Printed formulas of the software打印的软件公式
Figure2.2. Printed formulas of the software (Cont.)打印的软件公式（持续）
2.2 Validation of thecalculations 计算的验证
All calculations are verified with a system completelyindependent from the self developed software. One part of the recalculation isperformed by validation versus a commercial software, the other part with apocket calculator.
所有的计算应采用一个独立于自主开发软件的完整的系统进行确认。计算的一部分与商业软件进行对比，另一部分与计算器进行对比。
2.2.1 Validation of thecalculations versus commercial software 与商业软件对比的计算验证
Then, a dataset as close to real values as possible ischosen (Figure 1). Excel? calculations are compared to the results given bycommercial software, since it is considered as validated (Figure 3). Thecommercial software provides the coefficient of correlation, R2 and thecoefficients of the calibration curve. As no discrepancy occurs, the validationof this part of calculation is considered as fulfilled.
然后，可以选择一套尽可能接近真实值的数据（图1），用EXCEL进行计算，将其结果与商业软件给出的结果进行比较，因为该商业软件被认为是已经过验证的（图3）。商业软件给出线性系数，R2和校正曲线。由于没有出现不同结果，该部分计算的验证被认为是满足要求的。
Figure 3. Commercialsoftware results商业软件结果
2.2.2 Validation of thecalculations with a pocket calculator (Manual calculations) 采用计算器进行计算的验证（手动计算）
Concerning the other calculations, from printedformula from the spreadsheet, concentrations are calculated using a pocketcalculator (Figure 4) and then compared to the results of Figure 1. As nodiscrepancy occurs, the validation of this part of calculation is considered asfulfilled.
关于其它计算，从表格中打印出公式，用计算器计算浓度（图4），然后与图1中的结果进行比较。由于结果一致，计算这部分的验证可以认为是满足要求的。
Figure 4. Manualvalidation手动验证
Moreover, calculations in paragraph 2.2.1 and 2.2.2are re-performed with other datasets including exceptional situations, as forexample: OOS-results, missing data, or nonsense-data. Calculations are alsovalidated under these conditions (data not shown).
另外，在第2.2.1和2.2.2中的计算应采用其它数据包重新进行，包括一些例外情况，例如：OOS结果、数据缺少、或无意义数据。这些情况下的计算也应进行验证（数据未显示）。
At this stage, the software is considered asvalidated.
在本阶段，软件可以认为已经过了验证。
To ensure traceability of validation a certificate isemitted.
为保证验证的可追溯性，应发放一份验证证书。
2.3 Validation certificate验证证书
As the software is validated, a certificate ofvalidation is provided. It includes the name and the version of the software,the date of validation, the person responsible for the validation, the personresponsible for the release for use of the software and their signatures. Thisdocument (Figure 5) is kept in the software documentation.
在软件经过验证后，应提供一个验证证书。它包括软件名称和版本号，验证日期，验证负责人，软件使用放行负责人及其签名。本文件（图5）应保存在软件文档中。
Figure 5: Certificate of software validation软件验证证书
Name of the control laboratory控制实验室名称 |
|
| Certificate of software validation 软件验证证书 | |
Name of the software 软件名称 |
Validated version 软件版本号 |
Date of validation 验证日期 |
Person responsible for the validation 验证负责人 |
Person responsible for the release of the use of the software 软件使用放行负责人 |
Conclusion of the validation 验证结论 |
Date and signature of the person responsible for the validation 验证负责人签名和日期 | Date and signature of the person responsible for the release of the use of the software 软件使用放行负责人签名和日期 |
| | | |
Comment: This certificate is an example of theformalisation of the validation. Alternatively, a Quality Assurance form couldbe used.
备注：本证书是一个正式验证的举例，也可以采用一个质量保证格式来代替。
Moreover, the person responsible for the validationcan be the same as the one responsible for the release for use of the software.
另外，验证负责人可以与软件使用放行负责人是同一个人。
2.4 Software installation anddocumentation 软件安装和记录
The concrete installation is completed aftervalidation of the software. The operator signs the life form to attest itsproper installation. This form, which actually is a QA document, includes thename of the software, unique identification, localisation, and personresponsible for the software. It includes also verification and otherspecification as updates or any problem encountered (Figure 6). Verification iscompleted after installation and reported in the life form.
在验证之后，软件安装全部完成。操作人员在历史记录上签字证明其已被正确安装。该表格实际上是一个质量保证文件，包括软件名称、唯一识别号、位置和软件负责人。它还包括确认和其它更新标准，或遇到的问题（图6）。在安装后确认即告完成，在历史记录上应进行报告。
Figure 6. Life Form 历史记录表
Life form 历史记录表 | | |
Unique identification 唯一识别号 | | |
| | |
Person responsible for the software软件负责人 |
|
Date 日期 | | | Comment next intervention 建议下次干预 | | Signature of the person responsible for the software 软件负责人签字 |
30/04/2009 30/04/2009 | | Installation Verification 安装确认 | Next verification 下次确认 30/10/2009 | | |
| | | | | | | |
Comment: 备注
Another way to secure this Excel spreadsheet wouldhave been to install the software on a network-drive with restricted access.Only authorised staff would be able to write on this drive. The user would haveno right to save data or spreadsheets and would have only the right to fill the(permitted) cells and to print the data.
保护Excel表格的另一种方式是在网络驱动器上安装软件限制进入。仅被授权的员工可以写入这个驱动器，用户无权存贮数据或表格，只有权限填写（允许的）单元格以及打印这些数据。
3. REGULAR VERIFICATION OF THE SOFTWARE 软件的周期确认
Regularly (for example, every 6 months) or after everychange performed in the soft- or hardware configuration, the software ischecked to be sure that results have not changed. A known dataset is used andthe results are compared to the standard one (Figure 1).
对软件进行周期（例如每6个月）确认，或在每次软件或硬件参数变更后进行确认，以保证结果未被更改。使用一个已知的数据包并将结果与标准表格进行比较。（图1）
In order to help the operator, verificationinstructions with required information have been written (Figure 7).
为了帮助操作者，确认指令所需要的信息已写入（图7）。
Results from the verification are printed, dated,signed and kept with the life form.
将确认的结果打印出来，注明日期，签字，与使用的表格一起保存。
Each verification is registered in the life form(Figure 6) with the following information: Date of operation, intervention(i.e. verification), comments, and operator’s signature.
每次确认应登记在使用表格中（图6），包括以下信息：操作日期、干预（即确认）、评价和操作人员签字。
Comments: 备注
In case of an installation on a network drive with restrictedaccess (cf. comment in chapter 2.5), the regular verification would beoptional.
如果安装在一个网络硬盘上，并设有登录限制（参见第2.5章备注），则周期性的确认是可选的。
The check could have included the verification if thesave date of the software is still the same as after original installation.
检查可以包括确认软件保存日期是否还与原始安装日期相同。
Figure 7. Verification instructions确认指令
Verification instructions 确认指令 This document provides instructions for the periodic review of the software described below. 本文件提供周期性软件确认所需的指令如下： Location of the original file: C:\Name of the software\name.xls 原始文件位置：C:\Name of the software\name.xls Verification: All grey cells must be completed and compared to the template below: 确认：所有灰色单元格必须填写完整，并与下面模板进行比较。 l Information: Name of the operator, form number and date of verification. 信息：操作者姓名，表格编号和确认日期 l Reference product data: Heights. 对照产品数据：高度 l Vaccine data: Batch number and heights for the two batches. 疫苗数据：批号和两批的高度 Results: Print, date, sign and keep the results in the software file. 结果：将结果打印、签名及填写日期并保存在软件文件中。 Life form: Register your verification in the software life form. 历史记录表：将软件的确认情况登记在软件历史记录表中。 |
4. SPECIFIC DOCUMENTATION 指定文件
According to the guideline, in-house software shouldbe completed with the following specific documentation. The correspondencebetween the guideline table and each information/documentation of thevalidation of this Excel software (Specific documents and Figures) is indicatedbelow:
根据指南，自主开发软件应包括下列指定文件，以保证其完整。指南表格和被验证的Excel软件（指定的文件和图）的每个信息/文件对应关系见下表。
Information/documentation that should be available应有信息/文件 | | | |
Name, version and unique identification of the software 软件的名称、版本和唯一识别号 | | Life form and printings 历史记录表格和打印文件 | |
Original files (CD-ROM…) or storage location to install the software and software to manage the computer environment 原始文件（CD-ROM…）或软件安装的贮存位置，以及管理计算机环境的软件 | | Backup of the software on the network 在网络上对软件进行备份 | |
Date at which the software was put into operation 软件开始使用的日期 | | | |
Current physical location, where appropriate 现在的物理位置，如适用 | | | |
Responsible person in charge of the software 软件管理责任人 | | | |
Conditions under which the software runs, where applicable (hardware, operating system……)软件运行条件，如适用（硬件，操作系统…） | | | |
Name of the person who developed and validated the software, and the date of validation 开发和验证软件的人的姓名，验证的日期 | | Validation certificate 验证证书 | |
Source code (if available) 源代码（如可获得） | | | |
Operating rules, if appropriate 操作规则，适用时 | | | |
Documentation on software regular verification 软件定期确认的文件 | | Life form verification instructions 确认指令的历史记录表 | |
Documentation on software validation 软件验证的文件 | | Software validation file 软件验证文件 | Figure 1, 2.2, 2.2, 3, 4, 5 |
Follow-up encountered failures, maintenance of the process, updated versions and where appropriate, configuration management 跟踪遇到的失败、过程维护、版本升级以及适用时，参数设置管理 | | | |
|手机版|药群论坛
( 蜀ICP备15007902号 )
收藏
支持
反对