Healthcare & Life Sciences Software Testing Challenges

Various standards and regulations under 21 CFR Part 11, GxP Compliance, and Good Automated Manufacturing Practice must be followed by the healthcare and life sciences sector (GAMP). Adoption of digital technologies, big data analytics, and business intelligence (BI) are required for this. It also calls for compliance with a broad regulatory landscape, modernization of legacy systems, transformation of processes, and improvement of IT efficiency.

For a variety of life science and healthcare players, including hospitals, pharmaceutical firms, healthcare services, clinical labs, diagnostic facilities, third-party administrators (TPA), payers, medical equipment suppliers, healthcare ISVs, and research organisations, CDWT provides software testing solutions. With a focus on rules, compliance, quality, and other factors, we offer end-to-end advisory and transformation services, test automation, and performance, functional, and security testing solutions.

Medical Devices Testing Services

Because they directly affect patients’ lives, medical devices play a crucial role in the Healthcare & Life Sciences sector. Medical device makers need to constantly reinvent their products with the aid of software in order to provide patients with a superior and safe experience. However, the advantages of software also include the risk of flaws and problems. Thus, testing medical devices requires deep topic expertise, familiarity with local and national laws, device knowledge, testing infrastructure, and testing capability.

We are the preferred software testing service providers for major medical device manufacturers and consumers and an ISO13485:2016 Certified Organization. We assist you in overcoming obstacles in the software testing lifecycle of medical devices as well as in implementing best practises and recommendations.

Orthopaedic implants, contact lenses, ultrasound scanners, cardiac pacemakers, and other medical devices are all tested by CDWT’s specialist Medical Devices Testing CoE experts.

Our professionals have the necessary skills to assist Clients with the testing of their intelligent, AI-based medical and healthcare gadgets, such as Intelligent Beds, sterilisation tools, toolkits for pets, etc.

Medical Device Testing Approach

With a 5-step testing process that is in line with the development lifecycle, CDWT makes it possible to better understand the test requirements. We can test user and business requirements related to the system’s intended use thanks to our risk-based approach to validating the hardware, software, and peripheral devices.

Analysis Phase
  • Determine Medical devices in scope and regulatory compliance needs
  • Finalize Test Methodology, Approach and Deliverables
  • Validation Plan
  • Document requirements
  • Design Qualification
  • Risk Assessment
  • Impact Assessment
  • Validation Master Plan
  • Communcation Model
  • Metrics framework
Design Phase
  • Finalize Validation Plan
  • Protocol development (IQ, OQ, PQ)
  • Author Test cases/Scripts
  • Build Validation Approach
  • Requirement Traceability matrix
  • SOP development
  • Colaborate with Client on test data equirements
  • Validation Training
  • Sign off from client
Deployment Phase
  • Smoke testing on the test environment
  • Code / document reviews
  • Perform test execution
  • Execution of Verification and Validation documentation suit (for IQ, OQ, PQ)
  • Defect Logging and Retesting
  • Execution summary report
  • Sign off from Client
Closure Phase
  • Hardware and software Testexecution Summary Report
  • Defect Summary Report
  • Metrics and SLAs
  • System Release GO/No-Go Dashboard
  • Best Practices and Lesson Learnt
Maintenance Phase
  • Change control plan
  • Change request
  • Risk Assessment
  • Impact Assessment
  • Approval of change
  • Implementation of change
  • Re-validation of system as per requirements
  • System release Go/No-Go dashboard

Supported Regulations & Compliances

When it comes to testing medical devices, regulations and compliances, notably those from the US Food and Drug Administration (US FDA), are crucial. We have experience testing heavily regulated industries in the United States that are overseen and controlled by a number of state regulatory agencies as well as the federal regulatory body.

In order to verify and validate medical systems and their applications, we carry out the following sorts of testing:
Lifecycle V&V
GUI Testing
Performance Testing
Non-GUI Testing
Compliance Testing
Interoperability Testing
Behaviour Testing
Reliability Testing
User Acceptance Testing

Excellence Center for Medical Device Testing at CDWT

The Medical Devices Testing Center of Excellence at CDWT offers a variety of enterprises the following distinctive benefits:

  • Class I, Class II, and Class III medical device verification and validation expertise in the fields of diagnostics, imaging, orthopaedics, surgery, cardiology, and dentistry
  • evaluating a plan to meet the needs of the general public and regulatory authorities
  • knowledge of validating and verifying a variety of medical devices
  • An technique to testing that aligns test coverage with criteria that will highlight the errors most likely to occur
  • Design Failure Modes, Effects, and Criticality Analysis are used in risk-based testing (FMECA)

Healthcare and Life Sciences Domain Internal Training & Certification
Additionally, it offers the following medical device testing expertise:

  • Checks for Quality Control – Confirms Accuracy of Sample Analysis
  • System Suitability Tests – Confirms System Performs as Expected by Analysts
  • Proof that an analytical instrument is suitable for its intended use: analytical instrument validation
  • Analytical Method Validation – Demonstration that an analytical technique achieves the desired results

Computer System Validation (CSV) – Model

The CSV model is used by CDWT to deliver the following services:

A validation strategy that is in line with development improves comprehension of the test requirements
Using a risk-based methodology, the hardware, software, and peripheral devices are validated.
Testing of the user and business requirements related to the system's intended usage
Containing the required authentication checks for regulatory compliance
Functional and timely component verification for a variety of systems
By generating reports for internal and external audiences

Healthcare & Life Sciences Software Testing CoE

With the aid of our clients’ increased business value in healthcare and life sciences software testing, automation, mobile applications testing, connected health IoT, and regulatory testing, CDWT has a Healthcare and Life Sciences Software Testing Center of Excellence (TCoE) and a specific Hospital Application Test Approach. Our clients come from a variety of industries, including clinical labs, diagnostic facilities, hospitals, healthcare ISVs, healthcare services, manufacturers of medical equipment, payers, pharmaceutical firms, third-party administrators (TPA), and research institutions.

The following industries are covered by the competence of CDWT Healthcare & Life Sciences Software TCoE:

Pharmaceuticals Testing CoE

Utilizing its team’s strong pharma testing knowledge, CDWT complies with the majority of the regulatory authorities that are necessary to safeguard public health and safety.

The following areas receive experienced, end-to-end testing support from CDWT’s Pharma Testing CoE team:
Functional Testing
Integration Testing
API Testing
Regression Testing
Compliance Testing
Performance Testing
Security Testing
Usability Testing

Payer, PBM & TPA System CoE

Our Payer, PBM & TPA Systems TCoE is capable of providing services to the related to:
Payer – Provider Collaboration solutions
Provider Contract Management
Core Administration and Care Management
Broker and Member Systems
Member System (Enrolment, Termination, Reinstatement and Re-enrolment process)
Claims Management System
Portals and Information Exchange platforms
Healthcare Information Exchange platforms

Hospital Clinical Systems Testing Services

Testing services for Clinical Data warehouse
  • Testing for Data Validation, System Integration, Security, and System Ambiguity, as well as Dashboards & Reports, Performance & Stress, and Data Completeness, Correctness, Quality, and Accessibility
Testing services for Clinical Systems
  • Functional Testing: Test Automation and testing Regression, end-to-end, Compatibility, User Acceptance, System Integration, and E2E/Business Process
  • Non-Functional Testing: Testing for Security, Usability, Performance, Interoperability, along with Compliance & Regulatory testing

Carelink + Testing Expertise

  • SMEs with extensive experience in testing Carelink+ application
  • Functional consultants (Career Testers) with large scale implementations
  • Experienced Professionals with testing skillsets and certifications
  • Strong Expertise in multiple testing tools for Automation, Test & Defect Management
Test Accelertors
  • Pre-built Test Case Suite for out-of-the box functionality
  • Comprehensive set of Integrated Test Cases across the modules
  • Reduces effort on Test Design, & Test Authoring
  • Limited effort required for client specific customisation
  • Pre-built Test Management Checklist
Best Practices
  • Test Methodology and proven automation framework aligned to Carelink+ application
  • Leverage Cigniti Testing Best Practices in the areas of testing execution, issue tracking, and reporting
  • In-house Tools & Solution Accelerators developed to expedite the Testing process
  • Testing Center of Excellence (CoE) for leading enterprise applications and other Packaged Solutions
  • Extensive experience in testing Carelink+ modules – Roster, Forms, Reports, Advance Financial Package (AFP) modules
  • Integration and Interface Testing with other leading enterprise applications
  • End to End Business Process Testing (BPT), System integration, User Acceptance Testing and UX Monitoring / Testing
  • Test Data Management
  • Independent testing, Managed Test Center, Testing CoE