What is a Computer System Validation Process (CSV)?
Computer System Validation or CSV is also called software validation. CSV is a documented process that tests, validates, and formally documents regulated computer-based systems, ensuring these systems operate reliably and perform their intended functions consistently, accurately, securely, and traceably across various industries.
Computer System Validation Process is a critical process to ensure data integrity, product quality, and compliance with regulations.
Why Do We Need Computer System Validation Process?
Validation is essential in maintaining the quality of your products. To protect your computer systems from damage, shutdowns, distorted research results, product and sample loss, unstable conditions, and any other potential negative outcomes, you must proactively perform the CSV.
Timely and wise treatment of failures in computer systems is essential, as they can cause manufacturing facilities to shut down, lead to financial losses, result in company downsizing, and even jeopardize lives in healthcare systems.
So, Computer System Validation Process is becoming necessary considering following key points-
Regulatory Compliance: CSV ensures compliance with regulations such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP). By validating systems, organisations adhere to industry standards and legal requirements.
Risk Mitigation: By validating systems, organisations reduce the risk of errors, data loss, and system failures. QA professionals play a vital role in identifying and mitigating risks during the validation process.
Data Integrity: CSV safeguards data accuracy, completeness, and consistency. In regulated industries, reliable data is essential for decision-making, patient safety, and product quality.
Patient Safety: In healthcare, validated systems are critical for patient safety. From electronic health records to medical devices, ensuring system reliability is critical.
How to implement the Computer System Validation (CSV) Process?
You can consider your computer system validation when you start a new product or upgrade an existing product. Here are the key phases that you will encounter in the Computer System Validation process:
Planning: Establishing a project plan outlining the validation approach, resources, and timelines. Define the scope of validation, identify stakeholders, and create a validation plan. This step lays the groundwork for the entire process.
Requirements Gathering: Documenting user requirements and translating them into functional specifications and technical specifications.
Design and Development: Creating detailed design and technical specifications. Develop or configure the system according to the specifications. This step involves coding, configuration, and customization.
Testing: Executing installation, operational, and performance qualification tests. Conduct various tests to verify the system’s functionality, performance, and security. Types of testing include unit testing, integration testing, and user acceptance testing.
Documentation: Create comprehensive documentation, including validation protocols, test scripts, and user manuals. Proper documentation is essential for compliance.
Operation: Once validated, you can put the system into operation. Regular maintenance and periodic reviews are necessary to ensure ongoing compliance.
Approaches to Computer System Validation(CSV):
As we study, the CSV involves several steps, including planning, specification, programming, testing, documentation, and operation.Perform each step correctly, as each one is important. CSV can be approached in various ways:
Risk-Based Approach: Prioritize validation efforts based on risk assessment. Identity critical functionalities and focus validation efforts accordingly. This approach includes critical thinking, evaluating hardware, software, personnel, and documentation, and generating data to translate into knowledge about the system.
Life Cycle Approach: This approach breaks down the process into the life cycle phases of a computer system, which are concept, development, testing, production, maintenance and then validate throughout the system’s life cycle phases. This helps to follow continuous compliance and quality.
Scripted Testing: This approach can be robust or limited. Robust scripted testing includes evidence of repeatability, traceability to requirements, and auditability. Limited scripted testing is a hybrid approach that scales scripted and unscripted testing according to the risk of the system.
“V”- Model Approach: Align validation activities with development phases. The ‘V’ model emphasizes traceability between requirements, design and testing.
Process-Based Approach: Validate based on the system’s purpose and processes it serves. First one need to understand how the system interacts with users, data and other systems.
GAMP (Good Automated Manufacturing Practice) Categories: Classify systems based on complexity. It provides guidance on validation strategies for different categories of software and hardware.
Documentation Requirements:
Here are the essential documents for CSV during its different phases:
Validation Planning:
Project Plan:Document outlining the approach, resources, timeline, and responsibilities for CSV.
User Requirements Specification (URS):
User Requirements Document: Defines what the user wants a system must do from a user’s perspective. The system owner, end-users, and quality assurance write it early in the validation process, before the system is created. The URS essentially serves as a blueprint for developers, engineers, and other stakeholders involved in the design, development, and validation of the system or product.
Functional Specification (FS):
Functional Requirements: Detailed description of system functions, it is a document that describes how a system or component works and what functions it must perform.Developers use Functional Specifications (FSs) before, during, and after a project to serve as a guideline and reference point while writing code.
Design Qualification (DQ):
It is specifically a detailed description of the system architecture, database schema, hardware components, software modules, interfaces, and any algorithms or logic used in the system.
Functional Design Specification (FDS): Detailed description of how the system will meet the URS.
Technical Design Specification (TDS): Technical details of hardware, software, and interfaces
Configuration Specification (CS):
Additionally, Specifies hardware, software, and network configurations settings and how these settings address the requirements in the URS.
Installation Qualifications (IQ):
Installation Qualification Protocol: Document verifying that the system is installed correctly.
Operational Qualification (OQ):
Operational Qualification Protocol: Therefore, document verifying that the system functions as intended in its operational environment and fit to be deployed to the consumers.
Performance Qualification (PQ):
Performance Qualification Protocol: Document verifying that the system consistently performs according to predefined specifications under simulated real-world conditions.
Risk Scenarios:
Additionally identification and evaluation of potential risks associated with the system and its use and mitigation strategies.
Standard Operating Procedures (SOPs):
SOP Document, specifically is a set of step-by-step instructions for system use, maintenance, backup, security, and disaster recovery.
Change Control:
Change control refers to the systematic process of managing any modifications or adjustments made to a project, system, product, or service. It ensures that all proposed changes undergo a structured evaluation, approval, implementation, and subsequently its impact and documentation process.
Training Records:
Moreover, documentation of training provided to personnel on system operation and maintenance.
Audit Trails:
In summary, an audit trail is a sequential record of activities that have affected a device, procedure, event, or operation. It can be a set of records, a destination, or a source of records. Audit trails can include date and time stamps, and can capture almost any type of work activity or process, whether it’s automated or manual.
Periodic Review:
Scheduled reviews of the system to ensure continued compliance and performance. Additionally, periodic review ensures that your procedures are aligned with the latest regulations and standards, reducing the risk of noncompliance. Consequently, regular review can help identify areas where your procedures may not be in compliance with the regulations.
Validation Summary Report (VSR):
Validation Summary Report: Consolidates all validation activities performed and results obtained. Ultimately, it is a key document that demonstrates that the system meets its intended use and complies with regulations and standards. It also provides evidence of the system’s quality and reliability and any deviations or issues encountered during the validation process
It provides a conclusion on whether the system meets predefined acceptance criteria.
Traceability Matrix (TM):
Links validation documentation (URS, FRS, DS, IQ, OQ, PQ) to requirements, test scripts, and results.
Also known as Requirements Traceability Matrix (RTM) or Cross Reference Matrix (CRM)
By following these processes and documentation requirements, organizations can ensure that their computer systems are validated to operate effectively, reliably, and in compliance with regulatory requirements.
Conclusion
Computer System Validation (CSV) Process, therefore, is essential for ensuring that computer systems in regulated industries work correctly and meet safety standards. By following a structured validation process, organizations can protect data integrity, improve product quality, and reduce the risk of system failures.
Moreover, with ongoing validation and regular reviews, companies can stay compliant with regulations and adapt to new challenges. Ultimately, investing in a solid Computer System Validation approach not only enhances system reliability but also shows a commitment to quality and safety for users and stakeholders alike.
Trupti is a Sr. SDET at SpurQLabs with overall experience of 9 years, mainly in .NET- Web Application Development and UI Test Automation, Manual testing. Having hands-on experience in testing Web applications in Selenium, Specflow and Playwright BDD with C#.
Building a solenoid control system with a Raspberry Pi to automate screen touch means using the Raspberry Pi as the main controller for IoT Solenoid Touch Control. This system uses relays to control solenoids based on user commands, allowing for automated and accurate touchscreen actions. The Raspberry Pi is perfect for this because it’s easy to program and can handle the timing and order of solenoid movements, making touchscreen automation smooth and efficient. Additionally, this IoT Solenoid Touch Control system is useful in IoT (Internet of Things) applications, enabling remote control and monitoring, and enhancing the versatility and functionality of the setup.
Components Required:
Raspberry Pi (Any model with GPIO pins):
In our system, the Raspberry Pi acts as the master unit, automating screen touches with solenoids and providing a central control hub for hardware interactions. Its ability to seamlessly establish SSH connections and dispatch commands makes it highly efficient in integrating with our framework.
Key benefits include:
Effective Solenoid Control: The Raspberry Pi oversees and monitors solenoid operations, ensuring precise and responsive automation.
Remote Connectivity: With internet access and the ability to connect to other devices, the Raspberry Pi enables remote control and monitoring, enhancing flexibility and convenience.
Command Validation and Routing: Upon receiving commands, the Raspberry Pi validates them and directs them to the appropriate hardware or slave units. For instance, it can forward a command to check the status of a smart lock, process the response, and relay the information back to the framework.
Solenoide Holder(fix the solenoid):
A solenoid holder is crucial for ensuring the stability, protection, and efficiency of a solenoid control system. It simplifies installation and maintenance while improving the overall performance and extending the solenoid’s lifespan.
In this particular setup, the solenoid holders are custom-manufactured to meet the specific requirements of my system. Different screen setups may require differently designed holders.
Incorporating a solenoid holder in your Raspberry Pi touchscreen control system results in a more robust, reliable, and user-friendly solution.
Solenoid (Voltage matching your power supply):
Integrating solenoids into a Raspberry Pi touchscreen setup offers an effective method for adding mechanical interactivity and automating screen touches. To ensure optimal performance, it’s essential to choose a solenoid with the right voltage, current rating, and size for your specific application.
Whether you’re automating tasks, enhancing user experience, or implementing security features, solenoids play a vital role in achieving your project goals. With careful integration and precise control, they enable you to create a dynamic and responsive system.
Relay Module (Matching solenoid voltage and current rating):
A relay module acts as a switch controlled by the Raspberry Pi, enabling safe and isolated control of higher-power solenoids. To ensure reliable operation, choose a relay that can handle the solenoid’s current requirements.
Relay modules simplify complex wiring by providing clear connection points for your Raspberry Pi, power supply, and the devices you wish to control. These modules often come with multiple relays (e.g., 1, 2, 4, or 8 channels), allowing independent control of several devices.
Key terminals include:
COM (Common): The common terminal of the relay switch, typically connected to the power supply unit you want to switch.
NO (Normally Open): Disconnected from the COM terminal by default. When the relay is activated, the NO terminal connects to COM, completing the circuit for your device.
NC (Normally Closed): Connected to COM in the unactivated state. When the relay activates, the connection between NC and COM breaks.
Touchscreen display:
Touchscreens are like interactive windows on our devices. Imagine a smooth surface that reacts to your fingertip. This is the magic of touchscreens. They use hidden sensors to detect your touch and tell the device where you pressed. This lets you tap icons, swipe through menus, or even draw pictures – all directly on the screen. No more hunting for tiny buttons, just a natural and intuitive way to control your smartphones, tablets, and many other devices.
Breadboard and Jumper Wires:
Breadboard and jumper wires act as your temporary electronics workbench. They let you connect components without soldering, allowing for easy prototyping and testing. You can push wires into the breadboard’s holes to create circuits, making modifications and troubleshooting a breeze before finalizing the connections.
Voltage level Converter:
In our project, the voltage level converter plays a critical role in ensuring communication between the Raspberry Pi and the relay module. The relay module, like some other devices, needs a specific voltage (5V) to understand and respond to commands. However, the Raspberry Pi’s GPIO pins speak a different voltage language – they can only output signals up to 3.3V.
Directly connecting the relay module to the Raspberry Pi’s GPIO pin wouldn’t work. The lower voltage wouldn’t be enough to activate the relay, causing malfunctions. Here’s where the voltage level converter comes in. It acts as a translator, boosting the Raspberry Pi’s 3.3V signal to the 5V required by the relay module. This ensures clear and compatible communication between the two devices, allowing them to work together seamlessly.
Power Supply (Separate for Raspberry Pi and Solenoid):
We need two separate power supplies for safe and reliable operation.A 5V 2A power supply specifically powers your Raspberry Pi. It provides the lower voltage the Pi needs to function.A separate 24V 10A Switching Mode Power Supply (SMPS) powers the solenoid. This higher voltage and current capacity are necessary for the solenoid’s operation. Using separate power supplies isolates the Raspberry Pi’s delicate circuitry from the potentially higher power fluctuations of the solenoid, ensuring safety and proper operation of both.Each power supply is chosen to meet the specific requirements of its component: 5V for the Pi and a higher voltage/current for the solenoid.
Circuit Diagram:
Power Supply Connections:
Connect the Raspberry Pi power supply to the Raspberry Pi.
Connect the positive terminal of the separate power supply to one side of the solenoid.
Connect the negative terminal of the separate power supply to the common terminal of the relay.
Relay Module Connections:
Connect the Vcc pin of the relay module to the 5V pin of the Raspberry Pi.
Connect the GND pin of the relay module to the GND pin of the Raspberry Pi.
Connect a chosen GPIO pin from the Raspberry Pi (like GPIO 18) to the IN terminal of the relay module. This pin will be controlled by your Python code.
Connect one side of the solenoid to the Normally Open (NO) terminal of the relay module. This means the solenoid circuit is only complete when the relay is activated.
Connecting the Raspberry Pi to the Level Converter:
Connect a GPIO pin from the Raspberry Pi (e.g., GPIO17) to one of the LV channels (e.g., LV1) on the level converter.
Connecting the Level Converter to the Relay Module:
Connect the corresponding high-voltage (HV) pin (e.g., HV1) on the level converter to the IN1 pin of the relay module.
Connect the HV pin on the level converter to the VCC pin of the relay module (typically 5V).
Connect the GND pin on the HV side of the level converter to the GND pin of the relay module.
Powering the Relay Module:
Ensure the relay module is connected to a 5V power supply. This can be done using the 5V pin from the Raspberry Pi or a separate 5V power supply if needed. Connect this to the VCC pin of the relay module.
Ensure the GND of the relay module is connected to the GND of the Raspberry Pi to have a common ground.
Connecting the Relay Module to the Solenoid and 24V Power Supply:
Connect the NO (normally open) terminal of the relay to one terminal of the solenoid.
Connect the COM (common) terminal of the relay to the negative terminal of the 24V power supply.
Connect the other terminal of the solenoid to the positive terminal of the 24V power supply.
Software Setup:
Raspberry Pi Setup:
Let’s make setting up our Raspberry Pi with Raspbian OS, connecting it to Wi-Fi, and enabling VNC feel as straightforward as baking a fresh batch of cookies. Here’s a step-by-step guide:
1. Install Raspbian OS Using Raspberry Pi Imager:
Download Raspberry Pi Imager:
Install the Imager on our computer—it’s like the secret ingredient for our Raspberry Pi recipe.
Prepare Our Micro-SD Card:
Insert our micro-SD card into our computer.
Open Raspberry Pi Imager.
Choose the Raspberry Pi OS version you want (usually the latest one).
Select our SD card. Click “Write” and let the magic happen. This process might take a few minutes.
Connect Our Raspberry Pi via LAN Cable:
Plug one end of an ethernet cable into our Raspberry Pi’s Ethernet port.
Connect the other end to our router (the one with the internet connection).
Power Up Our Raspberry Pi:
Insert the micro-SD card into our Raspberry Pi.
Connect the power supply to our Pi.
Wait for it to boot up like a sleepy bear waking from hibernation.
Configure Wi-Fi and Enable VNC:
Find Our Raspberry Pi’s IP Address:
On our Raspberry Pi, open a terminal (you can find it in the menu or use the shortcut Ctrl+Alt+T).
Type hostname -I and press Enter. This will reveal our Pi’s IP address.
Access Our Router’s Admin Interface:
Open a web browser and enter our router’s IP address (usually something like 192.168.1.1) in the address bar.
Log in using our router’s credentials (check the manual or the back of our router for the default username and password)
Assign a Static IP to Our Raspberry Pi:
Look for the DHCP settings or LAN settings section.
Add a new static IP entry for our Raspberry Pi using the IP address you found earlier. Save the changes.
Enable VNC on Our Raspberry Pi:
On our Raspberry Pi, open the terminal again.
Type sudo raspi-config and press Enter.
Navigate to Interfacing Options > VNC and enable it.
Exit the configuration tool.
Access Our Raspberry Pi Remotely via VNC:
On our computer (not the Raspberry Pi), download a VNC viewer application (like RealVNC Viewer).
Open the viewer and enter our Raspberry Pi’s IP address.
When prompted, enter the password you set during VNC setup on our Pi.
2. Install Python Libraries:
Use the Raspberry Pi terminal to install the necessary Python libraries. You’ll likely need:
3. Python Code Development:
Write Python code to:
Activate the corresponding GPIO pin based on the touched button to control the relay.
Python code:
import RPi.GPIO as GPIO
import time
# GPIO pin numbers for the relays
relay_pins = [2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13]
def setup():
GPIO.setmode(GPIO.BCM) # Use BCM GPIO numbering
for pin in relay_pins:
GPIO.setup(pin, GPIO.OUT) # Set each pin as an output
GPIO.output(pin, GPIO.HIGH) # Initialise all relays to off (assuming active low)
def activate_solenoid(solenoid_number, duration=1):
if 1 <= solenoid_number <= 12:
pin = relay_pins[solenoid_number - 1]
GPIO.output(pin, GPIO.LOW) # Turn on the relay (assuming active low)
time.sleep(duration) # Keep the solenoid activated for the specified duration
GPIO.output(pin, GPIO.HIGH) # Turn off the relay
def cleanup():
GPIO.cleanup()
def get_user_input():
while True:
try:
user_input = input("Enter the solenoid number to activate (1-12), or 'q' to quit: ")
if user_input.lower() == 'q':
break
solenoid_number = int(user_input)
if 1 <= solenoid_number <= 12:
activate_solenoid(solenoid_number)
else:
print("Please enter a number between 1 and 12.")
except ValueError:
print("Invalid input. Please enter a number between 1 and 12, or 'q' to quit.")
if _name_ == "_main_":
try:
setup()
get_user_input()
except KeyboardInterrupt:
print("Program terminated")
finally:
cleanup()
Additional Considerations:
Flyback Diode: Adding a flyback diode across the solenoid protects the circuit from voltage spikes when the relay switches.
Status LEDs: LEDs connected to the GPIO pins can visually indicate relay and solenoid activation.
Security Measures: Consider password protection or other security features to control solenoid activation, especially for critical applications.
Putting it all Together:
Assemble the circuit on a breadboard, following the connection guidelines.
Flash the Raspberry Pi OS with your written Python code.
Design and implement the touchscreen interface using your chosen framework.
Test the system thoroughly to ensure proper functionality and safety.
Remember:
Always prioritize safety while working with electronics. Double-check connections and voltage ratings before powering on.
Conclusion
In conclusion, building a solenoid control system using a Raspberry Pi for IoT-based automated screen touch demonstrates a seamless integration of hardware and software to achieve precise and automated touchscreen interactions. The Raspberry Pi’s versatility and ease of programming make it an ideal choice for controlling solenoids and managing relay operations in IoT Solenoid Touch Control systems. This system not only enhances the efficiency and accuracy of automated touch actions but also expands its potential through IoT capabilities, allowing for remote control and monitoring. By leveraging the power of the Internet of Things, the IoT Solenoid Touch Control project opens up new possibilities for automation and control in various applications, from user interface testing to interactive installations.
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As a Software Development Engineer in Test (SDET), I specialize in developing automation scripts for mobile applications with integrated hardware for both Android and iOS devices. In addition to my software expertise, I have designed and implemented PCB layouts and hardware systems for integrating various components such as sensors, relays, Arduino Mega, and Raspberry Pi 4. I programmed the Raspberry Pi 4 and Arduino Mega using C/C++ and Python to control connected devices. I developed communication protocols, including UART, I2C, and SPI, for real-time data transmission and also implemented SSH communication to interface between the hardware and testing framework.
Preclinical trialsplay a critical role in the pharmaceutical industry, focusing on ensuring a new drug’s safety and efficacy before testing it in humans. As part of this process, preclinical software testing has emerged as an essential element in modern drug development. It ensures systems for managing, analyzing, and reporting preclinical data function correctly, securely, and comply with industry standards.
Preclinical trials are the foundational steps in the drug development process. Laboratories and researchers conduct these experiments on animals to gather crucial data on a drug’s safety, efficacy, and pharmacological properties before testing it on humans.
In the complex, regulated world of drug development, preclinical trials form the foundation for pharmaceutical advancements. These trials are the first step in bringing a new drug from the lab to the patient’s bedside.
Why are preclinical trials crucial?
Safety: Identifying potential side effects and toxicities early on protects human volunteers in clinical trials.
Efficacy: Evaluating a drug’s effectiveness in treating a specific disease or condition.
Dosage: Determining the optimal dosage for human use.
Pharmacokinetics and Pharmacodynamics: Understanding how a drug is absorbed, distributed, metabolized, and excreted, and how it exerts its therapeutic effects.
Regulatory Approval: Regulatory bodies, like the FDA, mandate thorough preclinical testing before approving a drug’s progression to human clinical trials. This ensures that only drugs with a reasonable safety profile move forward.
Risk Reduction: Preclinical trials identify issues early, reducing the risk of failure in costly later stages like clinical trials.
Definition and Role of Preclinical Trials
Preclinical trials are the phase of drug development that occurs before clinical trials (testing in humans) can begin. They involve a series of laboratory tests, animal studies designed to provide detailed information on drug’s safety, pharmacokinetics, and pharmacodynamics. These trials are crucial for identifying potential issues early, ensuring that only most promising drug candidates proceed to human testing.
Safety Evaluation and Toxic Effect Identification
Primary Objective: The foremost goal of preclinical trials is to assess the safety profile of a new drug candidate. Before any new drug can be tested in humans, it must be evaluated for potential toxic effects in animals. This includes identifying any adverse reactions that could occur.
Toxicology Studies: These studies aim to find a drug’s potential toxicity, identify affected organs, and determine harmful dosage levels. Understanding these parameters is critical to ensuring that the drug is safe enough to move forward into human trials
Testing in Animal Models
Proof of Concept: Preclinical trials help establish whether a drug is effective in treating the intended condition. Researchers conduct in vitro and in vivo experiments to determine if the drug achieves the desired therapeutic effects.
Mechanism of Action: These trials also help in understanding the mechanism by which the drug works, providing insights into its potential effectiveness and helping to refine the drug’s design and formulation.
Pharmacokinetics and Pharmacodynamics Analysis
Drug Behavior: Preclinical studies examine how a drug is absorbed, distributed, metabolized, and excreted in the body (pharmacokinetics). They also investigate the drug’s biological effects and its mechanisms (pharmacodynamics).
Dose Optimization: Understanding these properties is crucial for determining the appropriate dosing regimen for human trials, ensuring that the drug reaches the necessary therapeutic levels without causing toxicity.
Regulatory Compliance and Approval Requirements
Compliance: Regulatory agencies like the FDA, EMA, and other national health authorities mandate preclinical testing before any new drug can proceed to clinical trials. These trials must adhere to Good Laboratory Practice (GLP) standards, ensuring that the studies are scientifically valid and ethically conducted.
Data Submission: The data generated from preclinical trials are submitted to regulatory bodies as part of an Investigational New Drug (IND) application, which is required to obtain approval to commence human clinical trials.
Ethical Considerations and Alternatives to Animal Testing
Patient Protection: Protecting human volunteers from unnecessary risks is a paramount ethical obligation. Preclinical trials serve to ensure that only drug candidates with a reasonable safety and efficacy profile are tested in humans, thereby safeguarding participant health and well-being.
Alternatives to Animal Testing: There is growing interest in alternative methods, such as in vitro testing using cell cultures, computer modeling, and organ-on-a-chip technologies, which can reduce the need for animal testing and provide additional insights.
Future Advancements in Preclinical Research
Technological Innovations: Advances in biotechnology, such as CRISPR gene editing, high-throughput screening, and artificial intelligence, are poised to revolutionize preclinical research. These technologies can enhance the precision and efficiency of preclinical studies, leading to more accurate predictions of human responses.
Personalized Medicine: The future of preclinical trials also lies in personalized medicine, where drugs are tailored to the genetic makeup of individual patients. This approach can improve the safety and efficacy of treatments, making preclinical trials more relevant and predictive.
Summary of Significance and Impact
Preclinical trials are a vital step in the drug development pipeline, ensuring that new pharmaceuticals are safe, effective, and ready for human testing. By rigorously evaluating potential drugs in these early stages, the pharmaceutical industry not only complies with regulatory standards but also upholds its commitment to patient safety and innovation. Understanding the importance of preclinical trials provides valuable insights into the meticulous and challenging process of developing new therapies that can significantly improve patient outcomes and quality of life.
Role of Preclinical Software Testing in Trials:
Software plays a significant role in preclinical trials, especially in the analysis and management of data. Here’s how software testing is associated with preclinical trials:
Data Management and Analysis: Software is used to manage the vast amount of data generated during preclinical trials. This includes data from various experiments, toxicology studies, and efficacy tests. Software testing ensures that these systems function correctly and handle data accurately.
Simulation and Modeling: Computational models and simulations are often used in preclinical studies to predict how a drug might behave in a biological system. Testing these software models ensures that they are reliable and produce valid predictions.
Regulatory Compliance: Software used in preclinical trials must comply with regulations such as Good Laboratory Practices (GLP). Testing ensures that the software meets these regulatory requirements, which is crucial for the acceptance of trial results by regulatory bodies.
Integration with Laboratory Equipment: Software often controls or interacts with laboratory equipment used in preclinical trials. Thoroughly testing this software is essential to ensure accurate data collection and reliable results.
When it comes to FDA approval, the testing process for drugs and associated systems, including preclinical software testing, involves several critical aspects.
1. Data Integrity and Accuracy:
Testing Focus: As a manual tester, the goal is to ensure that all data entered and stored in the system maintains its integrity and remains free from corruption or unintended changes. This involves testing scenarios related to data entry, storage, modification, and retrieval, verifying that the system accurately processes and displays the data.
Testing Strategy: Testers should manually verify that data cleaning processes work as expected, identifying and flagging any inconsistencies or errors. They must also confirm that the system correctly implements validation rules, ensuring data accuracy.
2. Compliance with Good Laboratory Practices (GLP):
Testing Focus: Testing involves verifying that the software adheres to the standards set by GLP.This includes checking that the system correctly captures changes made to data in the audit trails and retains the data as per GLP regulations.
Testing Strategy: Manual testers should create, modify, and delete data to ensure that they accurately record all activities in the audit trails. Testers must also verify that the system follows data retention policies and ensures data is available for the required retention period.
3. Electronic Records and Signatures:
Testing Focus: Test the functionality of electronic records and signatures to ensure they meet the FDA’s 21 CFR Part 11 requirements, which govern the use of electronic documentation in place of paper records.
Testing Strategy: Testers must verify the accuracy and security of electronic records, ensuring they can create, store, and retrieve them without error. They should test electronic signatures to confirm they are secure, traceable, and properly linked to the corresponding record.
4. Validation of Computational Models:
Testing Focus: Validating computational models manually, as part of preclinical software testing, involves ensuring that the outputs generated are accurate and consistent with expected results, especially when dealing with predictive models in drug trials.
Testing Strategy: A tester should manually verify model predictions by comparing results with known experimental data and run tests to identify any sensitivity in the models to input variations.
5. Risk Management:
Testing Focus: In a manual testing environment, identifying and mitigating risks is essential. Testers must test for potential risks like system crashes, data breaches, or calculation errors and implement appropriate responses.
Testing Strategy: Use risk-based testing to identify high-priority areas that could present the greatest risks to the system. Manual testers must ensure that risk mitigation strategies (like data backup and failover systems) function as intended.
6. Regulatory Submissions:
Testing Focus: Manual testing ensures accurate system data compilation for regulatory submission, maintaining compliance and preventing errors effectively.
Testing Strategy: Testers must manually ensure submission packages include correctly formatted documents and data, verifying completeness and regulatory compliance. They must ensure the system presents the data in a clear and compliant format.
These aspects collectively ensure that manual testing plays a critical role in delivering reliable, accurate, and FDA-compliant software systems. Each testing step ensures quality control, identifies risks, and verifies software behavior matches real-world expectations.
Conclusion:
In the pharmaceutical world, preclinical trials are essential for ensuring drug safety and effectiveness. Preclinical software testing ensures system validation, guaranteeing data accuracy and reliability in trials, playing a crucial behind-the-scenes role. This work helps pave the way for successful drug development, making testers key players in advancing medical innovation.
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Jr. SDET proficient in Manual, Automation, and API.
My expertise extends to technologies such as Selenium, Playwright, Postman, SQL, GitLab, and Java. I am keen to learn new technologies and tools for test automation.
KPIs for Test Automation are measurable criteria that demonstrate how effectively the automation testing process supports the organization’s objectives. These metrics assess the success of automation efforts and specific activities within the testing domain. KPIs for test automation are crucial for monitoring progress toward quality goals, evaluating testing efficiency over time, and guiding decisions based on data-driven insights. They encompass metrics tailored to ensure thorough testing coverage, defect detection rates, testing cycle times, and other critical aspects of testing effectiveness.
Importance of KPIs
Performance Measurement: Key performance indicators (KPIs) offer measurable metrics to gauge the performance and effectiveness of automated testing efforts. They monitor parameters such as test execution times, test coverage, and defect detection rates, providing insights into the overall efficacy of the testing process KPIs will help your team improve testing skills
Identifying Challenges and Problems: Key performance indicators (KPIs) assist in pinpointing bottlenecks or challenges within the test automation framework. By monitoring metrics such as test error rates, script consistency, and resource allocation, KPIs illuminate areas needing focus or enhancement to improve the dependability and scalability of automated testing.
Optimizing Resource Utilization: Key performance indicators (KPIs) facilitate improved allocation of resources by pinpointing areas where automated efforts are highly effective and where manual intervention might be required. This strategic optimization aids in maximizing the utilization of testing resources and minimizing costs associated with testing activities.
Facilitating Ongoing Enhancement: Key performance indicators (KPIs) support continual improvement by establishing benchmarks and objectives for testing teams. They motivate teams to pursue elevated standards in automation scope, precision, and dependability, fostering a culture of perpetual learning and refinement of testing proficiency.
Benefits of KPIs:
Test Coverage clear objective: KPIs will help an unbiased view of the effectiveness of automation testing you with the help
Process Enhancement: KPIs highlight the areas for improvement while doing automation testing processes. So you can achieve continuous enhancement & efficiency.
Executive Insight: Sharing KPIs with the team will have transparency & a better understanding of what test automation can achieve
Process Tracking: Regular monitoring of KPIs tracks the status and progress of automated testing, ensuring alignment with goals and timelines.
KPIs For Test Automation:
1. Test Coverage:
Description: Test coverage refers to the proportion of your application code that is tested. It ensures that your automated testing encompasses all key features and functions. Achieving high test coverage is crucial for reducing the risk of defects reaching production and can also reduce manual efforts.
Examples of Measurements:
Requirements Traceability Matrix (RTM): Maps test cases to requirements to ensure that all requirements are covered by tests.
User Story Coverage: Measures the percentage of user stories that have been tested.
Description: This performance metric gauges the time required to run a test suite. Effective automation testing, indicated by shorter execution times, is critical for the deployment of software in a DevOps setting. Efficient test execution supports seamless continuous integration and continuous delivery (CI/CD) workflows, ensuring prompt software releases and updates.
Examples of Measurements:
Total Test Execution Time: Total time taken to execute all test cases in a test suite.
Average Execution Time per Test Case: Average time taken to execute an individual test case.
Description: This metric in automation measures the percentage of test cases that fail during a specific build or over a set period. It is determined by dividing the number of failed tests by the total number of tests executed and multiplying the result by 100 to express it as a percentage. Tracking this rate helps identify problematic areas in the code or test environment, facilitating timely fixes and enhancing overall software quality. Maintaining a low failure rate is essential for ensuring the stability and reliability of the application throughout the testing lifecycle.
Examples of Measurements:
Failure Rate Per Build: Percentage of test cases that fail in each build.
Historical Failure Trends: Trends in test failure rates over time.
Description: Active defects represent the present state of issues, encompassing new, open, or resolved defects, guiding the team in determining appropriate resolutions. The team sets a threshold for monitoring these defects, taking immediate action on those that surpass this limit.
Examples of Measurements:
Defect Count: Number of active defects at any given time.
Defect Aging: Time taken to resolve defects from the time they were identified.
Tools to Measure Active Defects:
Defect Tracking Tools: Jira, Bugzilla, HP ALM
Test Management Tools: TestRail, Zephyr, QTest
5. Build Stability:
Description: Build stability in automation helps measure the reliability and consistency of application builds. You can check how frequently builds pass or fail during automation. Monitoring build stability helps your team identify failures early, and maintaining build stability is necessary for continuous delivery (CI/CD) workflows.
Examples of Measurements:
Pass/Fail Rate: Percentage of builds that pass versus those that fail.
Mean Time to Recovery (MTTR): Average time taken to fix a failed build.
Description: Defect density measures the number of defects found in a module or piece of code per unit size (e.g., lines of code, function points). It helps in identifying areas of the code that are more prone to defects.
Examples of Measurements:
Defects per KLOC (Thousand Lines of Code): Number of defects found per thousand lines of code.
Defects per Function Point: Number of defects found per function point.
Description: Test case effectiveness measures how well the test cases are able to detect defects. It is calculated by the number of defects detected divided by the total number of defects.
Examples of Measurements:
Defects Detected by Tests: Number of defects detected by automated tests.
Total Defects: Total number of defects detected including those found in production.
Tools to Measure Test Case Effectiveness:
Test Management Tools: TestRail, Zephyr, QTest
Defect Tracking Tools: Jira, Bugzilla, HP ALM
8. Test Automation ROI (Return on Investment):
Description: This KPI measures the financial benefit gained from automation versus the cost incurred to implement and maintain it. It helps in justifying the investment in test automation.
Examples of Measurements:
Cost Savings from Reduced Manual Testing: Savings from reduced manual testing efforts.
Automation Implementation Costs: Costs incurred in implementing and maintaining automation.
Tools to Measure Test Automation ROI:
Project Management Tools: MS Project, Smartsheet, Asana
Test Management Tools: TestRail, Zephyr, QTest
9. Test Case Reusability:
Description: This metric measures the extent to which test cases can be reused across different projects or modules. Higher reusability indicates efficient and modular test case design.
Examples of Measurements:
Reusable Test Cases: Number of test cases reused in multiple projects.
Total Test Cases: Total number of test cases created.
Description: Defect leakage measures the number of defects that escape to production after testing. Lower defect leakage indicates more effective testing.
Examples of Measurements:
Defects Found in Production: Number of defects found in production.
Total Defects Found During Testing: Total number of defects found during testing phases.
Description: This KPI measures the effort required to maintain and update automated tests. Lower maintenance effort indicates more robust and adaptable test scripts.
Examples of Measurements:
Time Spent on Test Maintenance: Total time spent on maintaining and updating test scripts.
Number of Test Scripts Updated: Number of test scripts that required updates.
Tools to Measure Automation Test Maintenance Effort:
Key Performance Indicators (KPIs) are crucial for ensuring the quality and reliability of applications. Metrics like test coverage, test execution time, test failure rate, active defects, and build stability offer valuable insights into the testing process. By following these KPIs, teams can detect defects early and uphold high software quality standards. Implementing and monitoring these metrics supports effective development cycles and facilitates seamless integration and delivery in CI/CD workflows.
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As a Junior SDET with 2 years of hands-on experience, I specialize in both manual and automation testing for web and mobile applications. I have worked with a variety of technologies, including Selenium, Playwright, Cucumber, Appium, SQL, Java, JavaScript, and Python, to deliver comprehensive test solutions. My expertise covers both functional and regression testing, with a focus on ensuring quality across different platforms.
