The readers are welcome to submit the answers or links with appropriate answers.
- Why did you ever become involved in QA/testing?
- Wha is the difference between QA and testing?
QA Engineer questions were collected and published by Alex Samourin. Please visit his Xtreme testing page for much more.
9 Comments on QA engineer interview questions
BASIC DEFINATION OF VALIDATION ENGINEERING
• Audit Trail: Audit trail must be Secure, Computer generated, time-stamped, and independent. It record date and time of the operator entries and actions that create modify, or delete electronic records.
• Active Server Page(ASP): Microsoft’s technology to enables HTML pages to be dynamic and interactive by embedding scripts, i.e. either VBScript or JScript, Microsoft’s alternative of JavaScript. Since the scripts in ASP pages (suffix .asp) are processed by the server, any browser can work with ASP pages regardless of its support for the scripting language used therein. An ASP Tutorial, ASP Developer Network, Lots of ASP Links.
• CFR : Code of Federal Regulations
• Computer system validation: Validation of entire system. It’s a validation of hardware, software, procedure. {Its software testing in pharmaceutical company}
• CLOSED/OPEN system:
• CLOSED SYSTEM: An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
• OPEN SYSTEM: An environment in which system access is NOT controlled by persons who are responsible for the content of electronic records that are on the system
• Computer Validation life cycle: Planing and Specification>design>Construction>Testing>Installation>Acceptance testing>Operation.
• computer system :any programmable device including its software, hardware, peripherals, procedures, users, interconnections and inputs for the electronic processing and output of information used for reporting or control.
• Core Dossier: companies choose CoreDossier over other systems:
• It automates the entire regulatory publishing process
• It is the only solution that transforms over 100 file formats to PDF while maintaining 100% page fidelity
• It is the only solution that integrates with multiple repositories simultaneously
• It can be implemented on one server, or multiple servers depending on need and scalability requirements
• It supports multiple simultaneous output formats (e.g., PDF, paper, CD-ROM, Web, etc.)
• It has successfully published over 5,000 submissions, including some of the largest submissions in the world
• Documentum 4i: Documentum 4i is an enterprise-level document-management platform that can handle any document type but is particularly well-suited to compound documents that have a hierarchical structure. The product features a three-tier architecture
• a choice of relational databases for storage;
• the Documentum server providing the object layer;
• Documentum or Web browser client.
• Disaster recovery. Disaster Recovery Associates develop and provide business continuity planning software, as well as maintaining the Disaster Recovery Directory. The product range covers all phases, from business impact analysis to testing of the plan itself.
• Desktop Client: End user initiates signing through a desktop client module that integrates out-of-the-box with commonly used applications.
• Document cycle :
(1) Project Initial
(2) SRS, FRS,URS
(3) TDD/DS
(4) Coding
(5) IQ/OQ/PQ/USD
(6) Maintenances
(7) Retirement plan
DCM (Documentum Compliance Manager) 4.3: the Web Interface for DCM 4.3 includes:
• Document Relationship Management
• Manual Promotion of Controlled Content
• DCM Reports
• Issue To-Be Read Notifications
• Issue Change Requests and Change Notices
• Create and Edit DCM Routers
Developer studio: Are compiled, Can be written in different languages, such as Visual C++ and Visual Basic, Can access local computer resources as well as the Developer Studio object model, Can use arbitrary modal dialog boxes, Can directly read from or write to files on disk, using the Win32 API, Can use early binding for better run-time performance, Can control another application (.EXE)
• Digital signature: an electronic signature based upon Cryptographic methods of originator authentication, compared by using a set of rules and a set of parameters such that the identity of the data can be verified.
• EDMS (Engineering Data management Service): EDMS is a service of Software product that work together to provide electronic system of document management. It has two client modes.
(1) Desktop
(2) WebTop( we use web top)
And the various application that it support is
(1) One document management
(2) Import management
(3) Record manager
(4) Web publisher
(5) Business problem manager etc.
• EDMS provides:
(1) Typed integration with auto writing tools, Ms Words, Power point.
(2) It has the ability to easily seen and capture existing document
(3) It provides a power full workflow automation process associated with creating, receiving, approving, distributing and archiving.
(4) It allow full test servicing for user
(5) It provides unlimited scalability for supporting thousands of users and billions of documentation.
(6) It provides security on user and roles that protected valuable enterprise and contain knowledge documents.
• Electronic Signature: A computer data Compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the handwritten signature.
• End-to-end testing: It involves testing of a complete application enviournment in a situation that mimics real-world use, such as interacting with a database. Using network communication, or interacting with other hardware, application, or system if appropriate.
• FDA compliances: The FDA compliance statements refer to the FDA limitations only.
• Functional design specification (FDS): it provides the basic of the design of the system and its used to verify and validate the system during testing , ensuring all the required functions are present and that they are operate correctly .
• Gap analysis: To conduct a Gap Analysis, one must identify Gaps, holes, and area of contention where the application under Observation does not meets the standard requirements. An identified Gap suggests that a functionality or process need further development, either by modifying, improving or creating faulty / missing elements.
• GCP (Good Clinical Practice):
-Centralized Laboratory
-Data Acquisition and Reporting
-Remove data Entry
-Case Report Form System
-Clinical Supply System
• GLP (Good Laboratory system): management system that describes the organization and condition of the quality, integrity and validation in which laboratory studies are conducted.
-Laboratory information management
-laboratory Robotics
-Toxicology System
-stability System
-Environment Impact
• GMP (Good manufacturing Practice): management system that describes the organization and condition of the quality, Safety and Efficacy for preparation of finished drug products.
-Manufacturing Execution
-maintenance management
-calibration management
-Facility management System
-Support Chain Planning
• Installation Qualification (IQ): It confirms that software was installed successfully to the system manufacture’s specifications for correct and reliable functioning. IQ confirms that correct system components, products and software are installed, expected system parameters are set, the needed file structures, directories, and data base are in place, the proper profile are set-up .
• LIMS (Labority Information management system): LIMS and lab data management information into a single location to make your online search as quick, simple and easy as possible. Designed especially for analytical lab includes researched development (R&D) labs, in-process testing labs, Quality assurance (QA) labs and more .Versions/modules: “Limsophy†which is now standard LIMS of AAC and designed for Window’s XX, oracle, MS-SQL-Server.
• Labware LIMS. LabWare LIMS is a full-featured Client/Server Laboratory Information Management System (LIMS) integrated into the Windows environment. This architecture combines the power and security of a typical server with the ease of use provided by the Microsoft GUI. LabWare LIMS is one of the world’s first client configurable LIMS product, providing an unparalleled degree of client involvement in adapting the software to their specific needs
• Operation Qualification (OQ): It proves that system complies with the operational process requirements and works as intended throughout its operational range. OQ confirms that the system operates properly when working in its operational environment while applications are running throughout the anticipated range of system input and other variables. Required SOP’s are ready and user have been trained.
• Performance Qualification (PQ): PQ proves the system performs consistently as intended during normal operational use and remains in compliance with regulatory and user expectations.
• PQ /UAT summary report:
Summarizes the following:-
• Testing environment
• Testing performed
• Test results
• Limitations that could not be corrected
• Unresolved errors
• Each test script will be given a status of PASS or FAIL.
• Perform a Periodic Evaluation:
Regulatory compliance dictates that GxP system must be validated and remain in a Validated state. SPRI-05 states periodic reviews must be performed every 3 years from the last full validation or the last periodic evaluation. Its done on validated system already in production
• Periodic Evaluation Process:
• Collect/assess available documentation
• Prepare periodic review and evaluation reports
• PDF Aqua: PDF aqua puts the power of controlling mission-critical documents back in your hands by eliminating manual procedures and establishing a highly efficient electronic environment with rules based security. With PDF aqua you can define view and/or print- time document access & watermarking and the overlaying of document metadata onto document headers, footers and body’s on-the-fly as the document is released from the document base, ensuring that the document security settings always reflect the user’s permissions.
• Quick Test Pro: The Quickest is developed with top quality presentations, content and videos showing you exactly how to perform the features without guessing. Quick Test Professional satisfies the needs of both technical and non-technical users. It enables you to deploy higher-quality applications faster, cheaper, and with less risk.
• Retirement Plan: A document that describes the overall strategy and responsible parties for moving a computer system from operation status to inactive status.
• Requirements traceability matrices: this is used to verify that all stated and derived requirement are allocated to system component and other deliverable .the matrices is also used to determine the source of requirements . Requirement traceability includes Tracing to thing other than software that satisfied the requirements such as Capability, design element, manual operation test etc.
• Remediation plan: it’s a solution to bring back a system into compliance.
• Retrospective Evaluation: To justify that the legacy system has undergone review, and that the current systems supports data integrity.
• SLC (Software Life Cycle): The life cycle begins when an Application is first conceived and ends when it is no longer in use. It includes aspects such as initial concepts, requirements analysis, functional design, internal design, documentation planning, test planning, coding, document preparation, integration, testing, maintenance, updates, retesting, phase-out, and other aspects.
• SQL*LIMS: software is a complete laboratory information management system which aids in sample tracking, laboratory processes, workflow, data access, storage and regulatory compliance issues.
• Scripting language: A programming language designed specifically for Web site programming. Examples include JavaScript and VBScript.
• SOP (standard operating procedure): SOPs must be written specifically for the computer system to describe restart/recover, security, source code maintenance, and row data storage, archive and retrieval. Among the SOPs to be reviewed are those cover planning, requirement, design, code, test, configuration management and quality assurance. It’s a step by step description for anything.
• Security : The sophisticated used of security, rustication such as Password authorization etc allows system to use :
(1) Different version of same document i.e. previous version of update file link to one another and available for viewing.
(2) Viewers can add notes to document or alter or create version.
(3) Multiple component creation
(4) Take different piece of diff files and put together as required in one web document.
(5) Audit trail logging.
• SDLC(Software Development Life Cycle):
(1) concept and planning
(2) requirement gathering
(3) design
(4) implementation
(5) validation/test
(6) maintenances
(7) retirement
• SOPs have u written :
• Testing inputs and commands
• Security testing
• Stress testing
• Backup and recovery
• Startup shutdown and recovery
• Archive process
• SQL*LIMS: structured query Language *lab Information management System.
• Types of validation: The two types of validation are:
Prospective validation: the validation of a new system as it is developed
Retrospective validation: the validation of an existing system
• Test cases: A document which describe input action or event and expected response to determine the future of an application is working correctly .it should contain particulars such as test case Identifier, test case name , objectives , test conditions input data requirements ,steps and expected results .
• Test scripts: A document written to give detailed instructions for the setup, operation, and evaluation of results for a given test for a specific module of the target system being tested under the Test plan. Followings are include in Test Scripts:
• Test description
• Acceptance criteria
• Expected and actual result
• Initial and dates of execution
• Name of testers and reviewers
• Test Plan: a high level document that will describe the key elements associated with the testing of a computer system. A software project test plan is a document that describes the objectives, scopes, approach, and focus of a software testing effort.
• Test Plan Execution:
• Execute Test Scripts
• Record each issue on a separate incident Form
• Log all issue via an incident Log
• Make appropriate changes
• Re-test all modifications
• Prepare/UAT summary report
• Test Director: It’s a test management tools and it has many function like bug track and reporting, manage all test cases, store all cases.
• Technical design documentation (TDD): it is a document produced by the supplier prior to software coding.
• User Requirement Specifications (URS): A URS documents what the automation must or should do. The focus of the URS must be on the requirements themselves and these should be uniquely referenced by individual numbering and clearly highlighted within the document .Requirements must be unambiguous and written in a technical language that is understood by both user and supplier. The US is the foundation of a automation project and must support the design, testing, installation and operation of a control and automation system throughout it life cycle.
• Validation Master Plan: A high level document that describes how your company validates equipment, processes, computers, methods and so on. Such a document is typically called Validation Master Plan. It also includes information on who is responsible for what (by function, not by person’s name). Such a document should be developed for corporate, departments or sites.
• Validation summary Reports: it includes all the test results and summaries all the repots.
• Validation process:
• More than just testing
• Overall QA Program
• DEFINE the system
• DESIGN the system
• DEMONSTRATE performance of intended function and detection of errors.
• DOCUMENT the system and the process
Validation lifecycle: URS (User Requirement Specification)>>> FDS
(Functional Design Specification)>>> HDS (Hardware Design Specification) / SDS
(Software Design Specification)>>>Engineering>>> IQ (Installation Qualification)>>> OQ
(Operational Qualification)>>> PQ (Performance Qualification)
• Validation Facets : The validation efforts consists of 5 specific facets or processes, each alone , would not constitute a validation
• The Validation Master Plan (VMP)
• The Project Plan
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance or Process Qualification (PQ)
• VSR and VSD:
• VSD (Validation Summary Document): it indicates what to do and who is going to do it.
• VSR (Validation summary Report): it indicates what was done, who did it and what the results were.
• The VSD and VSR documents are considered “Bookend Deliverablesâ€Â
• Workflow manager: The Workflow Manager helps you manage site workflow for your organization. SiteMaker CMS users can efficiently communicate with one another, assign and review tasks, and read important web page notes while authorized users can review and publish web pages to the live site. Workflow Manager smoothly integrates disparate systems and structures complex business processes into a unified framework.
• 21 CFR parts 11, 210/211: Highlights of the Final Rule The final rule provides criteria under which FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures
• 21 CFR part 11:
(1) Security
(2) Calculation
(3) Environment monitory
(4) Stability
(5) Instrument interface
(6) Audit
•
I UPLOAD BASIC DEFINATION OF VALIDATION TESTING in ALPABETICAL ORDER( A—Z) i hope this will help u all for Interviews.
HEMANT DINKAR
Hi Dinakar,
Very much thnx to u ,really u provided a very good information
Hi hemant the part 211 and 210 whcih you have is for cGMP for finished products is the final rule is correct check it once again, and you have done grt JOB!!!!!1
Hi Hemant,
Thanks a lot, very usful information great work
The information contains in this site regarding testing is very good reference material and questions are very useful for upcoming QA as well as test engineers.
It contains splendid information of testing.
Hi can any one explain the google interview process for QA/Testing positions
Here are some more question
1) How you will write methods and by which name and what are the methods you will inherit.
2) Auditing and archiving.
3) Where you will find information about workflow regarding task, activity, running instance etc.
4) Object level permission and extended permission.
5) What is composite attr.
6) What are virtual documents.
7) Data dictionary related questions.
8) ACL, permission sets etc.
9) Annotations.
10) How you will register TBO and how you will write TBO’s.
11) D/f b/w onRender() and onRenderEnd() and other inherited methods.
12) Workflow manager related questions.
Ramkrishna
Capgemini
do a lot of Documentum technical interviews. Questions I like to ask
prospective technical resources…
(1) Describe the Documentum object model (I usually mention
dm_sysobject and custom types to give them a starting point, then I
wait to hear about dm_document, concept of inheritance, etc.)
(2) Describe the Documentum security model (looking to hear anything
about 7 layers of permissions, ACLs, user-defined security, folder-
defined security, etc.)
(3) What is the difference between a workflow and lifecycle? (I ask it
just like that and wait for a response. It might sound like a silly
question, but you’d be surprised)
(4) Describe how you would use and leverage third-party data in
Documentum (looking for an understanding of the concepts of DQL and
registered tables)
(5) Are you familiar with “dm_policy” objects? (I only ask it if they
answered #3 correctly, but it tells me whether or not they are familiar
with lifecycles at the object model level)
(6) What tools do you use to create custom object types? (Definitely
need to mention Developer Studio or App Builder here … if they
mention custom DQL scripts, then this is a plus)
(7) Have you worked with DocApps? (Again, simple question, but if you
don’t get a good response, then there are some fundamentals missing)
The “i_chronicle_id” question is a good one .. it will definitely weed
out a lot of people. But I don’t know if I’d throw out somebody that
didn’t know this. Especially if the interviewee didn’t have to work
with a lot of versioned objects.
Reply With Quote
Thanks
Ramkrishna
Capgemini