INTRODUCTION 介紹
The present document is the 1st Annex ofthe core document “Validation of Computerised Systems”, and it should be usedin combination with it when planning, performing and documenting the validationprocess of computerised systems.
本文件是核心文件 “計算機化系統的驗證”的第一個(gè)附件（關(guān)于EDQM“計算機化系統的驗證”指南的正文和其他內容將后續的日志中）。在計劃、實(shí)施和記錄計算機化系統驗證過(guò)程時(shí)，本文件應與核心文件結合使用。
The core document contains theIntroduction, Scope and general requirements for the validation of differenttypes of computerised systems.
核心文件包括了不同計算機化系統驗證的介紹、范圍和一般要求。
This Annex presents an example of Excel?spreadsheet validation, which is to be used in combination with the generalrecommendations given in the core document.
本附件給出了一個(gè)EXCEL表格驗證的例子，它可以與核心文件中給出的通用性推薦結合使用。
This document should be considered as aguide to OMCLs for planning, performing and documenting the validation of theircomputerised systems. It should not be taken as a list of compulsoryrequirements. It is left to the professional judgement and backgroundexperience of each OMCL to decide on the most relevant procedures to beundertaken in order to give evidence that their computerised systems areworking properly and are appropriate for their intended use.
本文件應作為OMCL在計劃、實(shí)施和記錄其計算機化系統時(shí)的指南。它不應被當成一個(gè)強制的要求。各OMCL應根據其專(zhuān)家的判斷和背景經(jīng)驗來(lái)決定其需要執行的最相關(guān)的程序，以提供證據來(lái)證明來(lái)計算機化系統工作正常，適用于其既定的用途。
1. SOFTWAREPRESENTATION AND GENERAL INFORMATION 軟件說(shuō)明和一般信息
This software’s aim is to calculate avaccine titration (Figure 1). From results obtained for a reference product(height measured 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.
這個(gè)軟件的目的是計算一個(gè)疫苗的滴定（圖1）。從一個(gè)對照產(chǎn)品（在4個(gè)濃度測得的高度）得到的結果，繪制一個(gè)校正曲線(xiàn)并計算出一個(gè)公式。這兩者均需要計算濃度和對應被檢測的疫苗所得的高度。
In Figure 1, grey cells are filled withnumerical data from experimentation and are the only ones that can be changedby the operator. All cells including formula are locked. No more than one cellfrom the calibration range can be empty; all cells for vaccines must be filledto guarantee proper use.
在圖一中，灰色單元格填充了試驗用的數字格式的數據，僅這些單元格可以由操作者更改。所有單元格，包括公式被鎖定。校正范圍內不超過(guò)一個(gè)單元格可以為空，所有單疫苗用的單元格應進(jìn)行填充以保證適當使用。
To access the software, a password isneeded to log on the computer.
應設置登錄計算機的密碼，以限制進(jìn)入軟件。
Back ups are regularly performed to ensureoriginal files preserving.
應定期進(jìn)行備份以保證原始文件的保存。
2. VALIDATIONSTAGES 驗證階段
The different stages of the validationare: 驗證的不同階段為
2.1 Printing of formulas 打印公式
2.2 Validation of the calculations 計算驗證
2.3 Validation certificate 驗證證書(shū)
2.4 Software installation anddocumentation 安裝軟件和記錄
2.1 Printing of formulas 公式打印
In order to validate the Excel?spreadsheet, formulas are printed, and the print is kept in the softwarevalidation file (Figures 2.1 and 2.2).
為了驗證EXCEL表格，要把公式打印出來(lái)，打印的文件要保存在驗證文件里（圖2.1和2.2）
2.2 Validation of the calculations 計算的驗證
All calculations are verified with asystem completely independent from the self developed software. One part of therecalculation is performed by validation versus a commercial software, theother part with a pocket calculator.
所有的計算應采用一個(gè)獨立于自主開(kāi)發(fā)軟件的完整的系統進(jìn)行確認。計算的一部分與商業(yè)軟件進(jìn)行對比，另一部分與計算器進(jìn)行對比。
2.2.1 Validation of the calculationsversus commercial software 與商業(yè)軟件對比的計算驗證
Then, a dataset as close to real values aspossible is chosen (Figure 1). Excel? calculations are compared to the resultsgiven by commercial software, since it is considered as validated (Figure 3).The commercial 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，可以選擇一套盡可能接近真實(shí)值的數據（圖1），用EXCEL進(jìn)行計算，將其結果與商業(yè)軟件給出的結果進(jìn)行比較，因為該商業(yè)軟件被認為是已經(jīng)過(guò)驗證的（圖3）。商業(yè)軟件給出線(xiàn)性系數，R2和校正曲線(xiàn)。由于沒(méi)有出現不同結果，計算的該部分驗證被認為是滿(mǎn)足要求的。
2.2.2 Validation of the calculations witha pocket calculator (Manual calculations) 采用計算器進(jìn)行計算的驗證（手動(dòng)計算）
Concerning the other calculations, fromprinted formula from the spreadsheet, concentrations are calculated using apocket calculator (Figure 4) and then compared to the results of Figure 1. Asno discrepancy occurs, the validation of this part of calculation is consideredas fulfilled.
關(guān)于其它計算，從表格中打印出公式，用計算器計算濃度，然后與圖1中的結果進(jìn)行比較。由于產(chǎn)生不同結果，計算的這部分驗證可以認為是滿(mǎn)足要求。
Moreover, calculations in paragraph 2.2.1and 2.2.2 are re-performed with other datasets including exceptionalsituations, as for example: OOS-results, missing data, or nonsense-data.Calculations are also validated under these conditions (data not shown).
另外，在第2.2.1和2.2.2段中的計算應采用其它數據包，包括一些例外情況進(jìn)行重新計算，例如：OOS結果、數據缺少、或無(wú)意義數據。這些情況下的計算也應進(jìn)行驗證（數據不顯示）。
At this stage, the software is consideredas validated.
在本階段，軟件可以認為已經(jīng)過(guò)了驗證。
To ensure traceability of validation acertificate is emitted.
為保證驗證的可追溯性，應發(fā)放一份驗證證書(shū)。
2.3 Validation certificate 驗證證書(shū)
As the software is validated, acertificate of validation is provided. It includes the name and the version ofthe software, the date of validation, the person responsible for thevalidation, the person responsible for the release for use of the software andtheir signatures. This document (Figure 5) is kept in the softwaredocumentation.
在軟件經(jīng)過(guò)驗證后，應提供一個(gè)驗證證書(shū)。它包括軟件名稱(chēng)和版本號，驗證日期，驗證負責人，軟件使用放行負責人及其簽名。本文件（圖5）應保存在軟件文檔中。
Name of the control laboratory
控制實(shí)驗室名稱(chēng)
Certificate of software validation
軟件驗證證書(shū)
Name of the software
軟件名稱(chēng)
Validated version
軟件版本號
Date of validation
驗證日期
Person responsible for the validation
驗證負責人
Person responsible for the release of the use of the software
軟件使用放行負責人
Conclusion of the validation
驗證結論
Date and signature of the person responsible for the validation
驗證負責人簽名和日期
Date and signature of the person responsible for the release of the use of the software
軟件使用放行負責人簽名和日期
Figure 5:Certificate of software validation
Comment: This certificate is an example ofthe formalisation of the validation. Alternatively, a Quality Assurance formcould be used.
備注：本證書(shū)是一個(gè)正式驗證的舉例，也可以采用一個(gè)質(zhì)量保證格式來(lái)代替。
Moreover, the person responsible for thevalidation can be the same as the one responsible for the release for use ofthe software.
另外，驗證負責人可以與軟件使用放行負責人是同一個(gè)人。
2.4 Software installation anddocumentation 軟件安裝和記錄
The concrete installation is completedafter validation of the software. The operator signs the life form to attestits proper installation. This form, which actually is a QA document, includesthe name 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.
在驗證之后，軟件安裝全部完成。操作人員在歷史記錄上簽字證明其已被正確安裝。該表格實(shí)際上是一個(gè)質(zhì)量保證文件，包括軟件名稱(chēng)、唯一識別號、位置和軟件負責人。它還包括確認和其它更新標準，或遇到的問(wèn)題（圖6）。在安裝后確認即告完成，在歷史記錄上應進(jìn)行報告。
Life form 歷史記錄表
Name of the software
軟件名稱(chēng)
Form number
表格編號
Unique identification
唯一識別號
Manufacturer
生產(chǎn)商
Location 位置
Person responsible for the software
軟件負責人
Date
日期
Encountered problem
遇到的問(wèn)題
Intervention
干預類(lèi)型
Comment next intervention
建議下次干預
Operator
操作人員
Signature of the person responsible for the software 軟件負責人簽字
30/04/2009
30/04/2009
Installation Verification
安裝確認
Next verification
下次確認
30/10/2009
X C
XC
AQ number: ELYO/XXX Version Y 30/01/2007
Validated by ZZZ
Figure 6. LifeForm 歷史記錄表
Comment: 備注
Another way to secure this Excelspreadsheet would have been to install the software on a network-drive withrestricted access. Only authorised staff would be able to write on this drive.The user would have no right to save data or spreadsheets and would have onlythe right to fill the (permitted) cells and to print the data.
保護EXCEL表格的另一種方式是在網(wǎng)卡驅動(dòng)上安裝軟件限制進(jìn)入。僅被授權的員工可以寫(xiě)入這個(gè)驅動(dòng)，用戶(hù)無(wú)權存貯數據或表格，只有權限填寫(xiě)（允許的）單元格以及打印這些數據。
3. REGULARVERIFICATION OF THE SOFTWARE 軟件的周期確認
Regularly (for example, every 6 months) orafter every change performed in the soft- or hardware configuration, thesoftware is checked to be sure that results have not changed. A known datasetis used and the results are compared to the standard one (Figure 1).
對軟件進(jìn)行周期（例如每6個(gè)月）確認，或在每次軟件或硬件參數變更后進(jìn)行確認，以檢查保證結果未被更改。使用一個(gè)已知的數據包并將結果與標準表格進(jìn)行比較。
In order to help the operator,verification instructions with required information have been written (Figure7).
為了幫助操作者，確認指示和需要的信息已寫(xiě)入（圖7）。
Results from the verification are printed,dated, signed and kept with the life form.
將確認的結果打印出來(lái)，注明日期，簽字，與使用的表格一起保存。
Each verification is registered in thelife form (Figure 6) with the following information: Date of operation,intervention (i.e. verification), comments, and operator’s signature.
每次確認應登記在使用表格中（圖6），包括以下信息：操作日期、類(lèi)型（即確認）、評價(jià)和操作人員簽字。
Comments: 備注
In case of an installation on a networkdrive with restricted access (cf. comment in chapter 2.5), the regularverification would be optional.
如果安裝在一個(gè)網(wǎng)絡(luò )硬盤(pán)上，并設有登錄限制（參見(jiàn)第2.5章備注），則周期性的確認是可選的。
The check could have included theverification if the save date of the software is still the same as afteroriginal installation.
檢查可以包括確認軟件保存日期還與原始安裝日期相同。
Verification instructions 確認指令
This document provides instructions for the periodic review of the software described below.
本文件提供周期性軟件確認所需的指令如下：
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:
確認：所有灰色單元格必須填寫(xiě)完整，并與下面模板進(jìn)行比較。
l Information: Name of the operator, form number and date of verification.
l 信息：操作者姓名，表格編號和確認日期
l Reference product data: Heights.
l 對照產(chǎn)品數據：高度
l Vaccine data: Batch number and heights for the two batches.
l 疫苗數據：批號和兩批的高度
Results: Print, date, sign and keep the results in the software file.
結果：將結果打印、簽名及填寫(xiě)日期并保存在軟件文件中。
Life form: Register your verification in the software life form.
歷史記錄表：將軟件的確認情況登記在軟件歷史記錄表中。
Figure 7. Verificationinstructions
4. SPECIFICDOCUMENTATION 指定文件
According to the guideline, in-housesoftware should be completed with the following specific documentation. Thecorrespondence between the guideline table and each information/documentationof the validation of this Excel? software (Specific documents and Figures) isindicated below:
根據指南，自主開(kāi)發(fā)軟件應包括下列指定文件，以保證其完整。指南表格和被驗證的EXCEL軟件（特定的文件和圖）每個(gè)信息/文件對應見(jiàn)下表。
Information/documentation that should be available 應有信息/文件
In-
House 自主開(kāi)發(fā)
Specific documents
指定文件
Figures
圖號
Name, version and unique identification of the software 軟件的名稱(chēng)、版本和唯一識別號
X
Life form and printings 歷史記錄表格和打印文件
Figure 6
圖6
Original files (CD-ROM…) or storage location to install the software and software to manage the computer environment 原始文件（CD-ROM。。。）或軟件安裝的貯存位置，以及管理計算機環(huán)境的軟件
X
Backup of the software on the network
在網(wǎng)絡(luò )上對軟件進(jìn)行備份
Date at which the software was put into operation
軟件開(kāi)始使用的日期
X
Life form 歷史記錄表
Figure 6
Current physical location, where appropriate
現在的物理位置，如適用
X
Life form歷史記錄表
Figure 6
Responsible person in charge of the software
軟件管理責任人
X
Life form歷史記錄表
Figure 6
Conditions under which the software runs, where applicable (hardware, operating system……)
X
Not applicable 不適用
Name of the person who developed and validated the software, and the date of validation
開(kāi)發(fā)和驗證軟件的人的姓名，驗證的日期
X
Validation certificate
驗證證書(shū)
Figure 5
Source code (if available)
源代碼（如可獲得）
X
Printing of formulas
公式打印
Figure 2.1 and 2.2
Operating rules, if appropriate
操作規則，適用時(shí)
X
Not appropriate
不適用
Documentation on software regular verification
軟件定期確認的文件
X
Life form verification instructions
確認指令的歷史記錄表
Figure 6 and 7
Documentation on software validation
軟件驗證的文件
X
Software validation file 軟件驗證文件
Figure 1, 2.2, 2.2, 3, 4, 5
Follow-up encountered failures, maintenance of the process, updated versions and where appropriate, configuration management
跟蹤遇到的失敗、過(guò)程維護、版本升級以及適用時(shí)，參數設置管理
X
Life form
歷史記錄表
Figure 6
