LIMS (Laboratory Information Management System), ERP (Enterprise Resource Planning), eDMS (electronic Document Management System), ELN (Electronic Laboratory Notebooks), user-developed Excel spreadsheet, user-developed Access application, automated sample processing systems, liquid chromatograph (LC, HPLC), gas chromatograph (GC) including auto sampler and detection systems (UV, VIS, IR, MS, NMR, radioactivity or fluorescence monitor, etc.), biological analyser, ECG, etc.
LIMS(實驗室信息管理系統(tǒng))、ERP(企業(yè)資源規(guī)劃系統(tǒng))、eDMS(電子文件管理系統(tǒng))、ELN(實驗室電子筆記本)、用戶自行開發(fā)的Excel電子表格、用戶自行開發(fā)的訪問應(yīng)用程序、自動樣品處理系統(tǒng)、液相色譜(LC、HPLC)、氣相色譜,包括自動進(jìn)樣檢測系統(tǒng)(UV, VIS, IR, MS, NMR, 放射性或熒光監(jiān)測等)、生物分析儀、ECG等
Validation
驗證
Complex
復(fù)雜的
部分翻譯如下:
VALIDATION OF
COMPLEX COMPUTERISED SYSTEMS
復(fù)雜計算機(jī)化系統(tǒng)的驗證
Note: Mandatory
requirements in this guideline and its annexes are defined using the terms
?shall? or ?must?. The use of ?should? indicates a recommendation. For these
parts of the text other appropriately justified approaches are acceptable. The
term ?can? indicates a possibility or an example with non-binding character.
This is the 2nd
Annex of the core document “Validation of Computerised Systems”, and it should
be used in combination with the latter when planning, performing and
documenting the validation steps of complex computerised systems Excel
spreadsheet validation is described in the 1st Annex of the core document and
not subjected here.
The selection and
purchase of new software and the associated computer and laboratory equipment
should follow a conscious decision-making process based on the requirements for
the intended use of the computerised system. A User Requirements Specification
(URS) should describe the functional and technical requirements of the
computerised system, as defined by the OMCL, in terms of both software and
hardware. It should also cover the aspects of information security and
g) Specifications
of macros, formulas and control commands;
宏指令、公式和控制命令的規(guī)范
h) Specifications
of the data inputs (e.g. format, decimal places, units);
數(shù)據(jù)輸入的規(guī)范(如格式、小數(shù)位數(shù)、單位)
i) Specification of
the mandatory fields for data;
數(shù)據(jù)必填項目的規(guī)范
j) Specifications
of the protection of masks, working sheets or the whole application;
Mask、工作表或整個應(yīng)用的保護(hù)
k) Planning of the
data migration, if applicable;
數(shù)據(jù)遷移的計劃,如適用
l) Specifications
for traceability of data entry and changes (audit trail) of interfaces to other
system components, if applicable.
數(shù)據(jù)輸入、修改(審計追蹤)
The URS shall be
released by a responsible person. Changes to the requirements are possible but
the changes should be traceable and the URS document should be version
controlled or an equivalent system established in order to ensure traceability.
New or changed requirements should be communicated to all persons involved.
The correct
installation of the system in the IT environment with defined hardware and
operating software shall be documented and tested. Detailed installation
procedures should be available and carried out by well-trained personnel only.
Checklists with
predefined installation steps and acceptance criteria can ensure the correct
installation of the system and the traceable qualification of the
installation.
In most cases, the
computerised system is connected to a computer network with interfaces to other
software (other applications) and hardware (computer equipment or laboratory
equipment). It must be ensured that the system is correctly integrated and that
all components are operative.
a) A check of the
required system resources both of the server and client, when applicable (e.g.
supported operating system, database engine, performance of the processor, free
space on the hard disk, memory, access rights for installations);
b) Documentation of
the components of the system (as a minimum, a description of the components and
version of the relevant components with date of implementation);
系統(tǒng)部件的文件記錄(至少描述部件和版本)
c) List of users or
user groups with access to the application, including type of access;
可用訪問應(yīng)用的用戶或用戶組清單,包括訪問類型。
d) Integration test
and/or communication test for the interfaces to other systems/equipment.
與其他系統(tǒng)/設(shè)備的接口的連接測試和/或通訊測試
Often the
installation is supported by the supplier and the internal IT unit.
通常,安裝由供應(yīng)商和內(nèi)部IT部門支持。
4. OPERATIONAL
QUALIFICATION (OQ)
運行確認(rèn)(OQ)
The proper
functioning of the software shall be checked by testing the key functions, e.g.
calibration and quantification (internal standards, external standards), peak
identification, and calculation of system suitability parameters.
Ideally, a raw data
set can be used for which the results are known. These raw data sets are often
provided by the supplier of the software, are processed by the software and the
results are then compared to the expected values.
If no such data
sets are available, example raw data sets can be acquired by running typical
samples. The results of the processed raw data sets should be verified by
recalculating the key parameters (e.g. calibration curves from peak areas of
standards) using standard (e.g., spreadsheet) software.
Raw data from the
testing of functions affecting the measurement result and its associated measurement
uncertainty (input and output data, screenshots) shall be documented within the
qualification report.
Operational
qualification should be repeated in a risk-based approach after installation of
new software modules, new software versions, new service packs, patch updates,
or after major changes in the software structure of the computer (e.g. new
anti-virus software). A similar approach should be taken for every change in
hardware platform or system upgrades.
The aim of the
performance qualification is to demonstrate that a computerised system is
suitable for its intended purpose in the user’s own environment as defined in
the URS. The user requirements shall be tested in the PQ phase to cover the
overall business use of the system in the daily routine.
a) Tests of
functions (e.g. with a data set to ensure each feature of the application is
tested);
功能測試(如使用數(shù)據(jù)序列確認(rèn)應(yīng)用軟件的每一個特性)
b) Negative or
limit test (e.g. input of values outside the specified range);
負(fù)面或邊界測試(如輸入超出規(guī)定范圍的數(shù)值)
c) Test of alarm
displays, if applicable (e.g. display of an OOS result);
報警顯示測試,如適用(如OOS結(jié)果展示)
d) Unauthorised
input of data and access to the application;
數(shù)據(jù)非授權(quán)輸入和應(yīng)用軟件非授權(quán)訪問
e) Tests of
aberrant data (e.g. input of data in the wrong data format);
異常數(shù)據(jù)測試(如輸入錯誤格式數(shù)據(jù))
f) Backup system
and restore test;
備份系統(tǒng)和恢復(fù)測試
g) Verification of
data migration, if applicable;
數(shù)據(jù)遷移確認(rèn),如適用
h) Conformity with
requirements of data protection, if applicable;
數(shù)據(jù)保護(hù)是否符合要求,如適用
i) Black box test
as acceptance testing of the whole system.
黑盒測試作為整個系統(tǒng)的可接受性測試
Each test scenario
should be traceable to the URS being tested and should describe the expected
results, the acceptance criteria and the observed results. Each deviation from
the expected results and acceptance criteria must be discussed in the test
report. A deviation can either lead to a change in the system and the test
being run again or be accepted and documented with an update of the
corresponding URS. Raw data from the testing (input and output data,
screenshots) shall be documented within the qualification report.
A summary of all
the test findings shall be presented in a validation report, including any
deviation and the corrective actions taken. When all deviations are resolved or
accepted, a formal release of the system is issued.
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