Life Sciences

Drug development is difficult on multiple levels. Long gestation periods, multiple rounds of trials, large budgets, and, finally, accuracy are required because it deals with human lives. Compliance is required under stringent regulations.

Databrass provides Life Sciences companies with better decision-support systems that help improve product safety and compliance while allowing for shorter clinical runs and a faster time to market.

Testing Healthcare Applications

Patient care is a serious business, and any error can have a negative impact not only on business processes, which would incur significant costs to repair, but also on patient safety. As a result, every healthcare service provider must test healthcare solutions for safety, performance, functionality, security, and compliance.

We have extensive experience assisting top organisations in the implementation of a wide range of software validation and verification testing based on GAMP and cGMPs. Indium Software consultants test IQ/OQ/PQ protocols using best practices and provide documentation on test scripts/results.

DataBrass's experts also assist regulated industries in meeting FDA regulations 21 CFR Part 11, Part 820, and Part 58, which require system assurance.

To meet the increasing requirements for interoperability and regulatory compliance, testing healthcare applications necessitates a significant amount of expertise and effort. Three critical areas that must be tested are:

Interoperability issues between disparate legacy systems
Adherence to ever-changing regulatory compliance requirements
Making application compatible with evolving technologies and protocols

DataBrass's helps achieve this goal by:

Developing, managing, and coordinating all regulatory requirements in accordance with compliances
Ensure functional consistency across version upgrades, product enhancements, and changes for application compliance
Integrate quality processes and compliance tasks
Providing detailed documentation, as well as process improvement reports and templates
Developing and implementing testing strategies to address areas of noncompliance; and
Creating and publishing compliance activity status reports on a regular basis.

DataBrass's Healthcare and Life sciences Expertise:

In compliance, our expertise spans across:

Medicare
Medicaid
HIPAA

ICD 10
FDA

Testing Life Science Applications

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Testing Domain Expertise

Testing Life Science Application

DataBrass's Testing Solution for Regulated Industries includes

Developing a software validation framework, as well as a test bed and test scripts

Risk-based assessment testing to ensure process compliance and quality improvement
Making suggestions for improvements to your current processes, systems, and documentation in order to demonstrate compliance with GxP requirements and industry standards.
Bringing quality processes and compliance responsibilities together
Solution alignment with various compliance parameters Providing extensive documentation, as well as reports and templates for process improvement

In addition to our comprehensive services, DataBrass offers jump start kits (Domain Expertise, Validation, and Document Templates) to meet immediate needs.

Databrass 's Life Sciences / Pharma Expertise

End To End Testing Expertise
Functional Automation Testing
Performance Testing
Integration Testing<

Security Testing
Accessibility Testing
Compatibility Testing
Data Migration Testing

Application Expertise

LIMS- Drug Development/Clinical Trials
Clinical Data Warehousing Solution
Electronic Data Capture System
Advanced Laboratory Testing<
Research Content Management Software<

Compliance Expertise

FDA regulations 21 CFR Part 11, Part 820 and Part 58
Medicare
Medicaid
HIPAA
ICD 10

How Can We Help You?

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