3 Typical Test Environments in System Development Life Cycle (SDLC)

test environment

 

This article describes the most common software application environments considered during the System Development Life Cycle (SDLC).  The three (3) most common phases or environments include Development Environment, Testing Environment, and Operational Environment.

testing environment
The most common Application Environments of the System Development Life Cycle SDLC

 

The System Development Life Cycle (SDLC) describes the activities and tools required to perform a particular process within each environment. The SDLC environments are defined as controlled points where developers can carry out activities related to development, testing, installation, configuration, and deployment. These three (3) environments are associated with the different phases considered during the SDLC.

The validation strategy should consider and define the scenario required for each environment. Particular tests and challenges may take place in each environment during the SDLC:

1. Development Environment

It is where prototyping or programming takes place before moving to the test environment.  It is a dedicated workplace (e.g. servers, client stations, database, etc) and tools for developing, and debugging an application or program. In this workplace is where the developer tests code and checks whether the application runs successfully with that code. Once the application has been tested and the developer feels that the code is working fine, the application then moves to the testing environment also called an Integrated Development Environment (IDE).

An integrated development environment (IDE) provides comprehensive applications to computer programmers for software development. An IDE commonly contains a source code editorbuild automation tools, and a debugger.

2. Testing Environment

The test environment is where formal verification and validation are performed before moving to the operational environment fully implemented for production use.  This workplace environment and its configuration must be similar to the operational (production) environment.  It is a dedicated workplace (e.g. servers, client stations, database, etc) and tools to make formal testing on applications or programs.  Commonly, called the validation environment since testing is done also in the development and operational environments.  

The application is verified and validated in the testing environment to check for reliability and to make sure it does not fail.  A fully documented validation is performed in the testing environment as the final step before the application could be deployed in an operational environment. The validation needs to be approved in order to deploy it in the operational environment.

3. Operational Environment

Once the application is verified and validated, the application then becomes a part of the operational environment. It is known as the production environment because it is where the application go-lives.

Also called the production environment, it is the workplace where the system is in its target environment or final location for commercial or deployment use.

The operational environment is a workplace where software and other products are actually challenged once they are placed into operation for their intended uses by end-users.

An operational environment contains the real-time setting where programs are run and hardware setups are installed and relied on for organization or commercial daily operations.

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For more details on specific FDA expectations and how to perform a Computer System Validation in the corresponding Application Environment, follow us.

validation templates online

Three (3) Options to Create a Computer System Validation Protocol:

Option 1. You Can Create a CSV Protocol, using a Template.

You can download samples of the validation templates in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We Can Bring You a Formal Training on How to Perform Computer System Validation in the Test Environment Using Our Template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We Can Create a Customized Computer System Validation Protocol for your Test Environment.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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References: Test Environment

https://www.fda.gov/media/73141/download

Food and Drug Administration References

  1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
  2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
  3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
  4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
  5. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Industry References

  1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)
  2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
  3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)
Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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