Build continuous compliance and auditability
to meet regulatory requirements with confidence.
Computer System Validation
Regulated Software Testing
SQA provides advisory consulting services as well as on-demand resources that have extensive experience in the biotech, medical device and pharmaceutical industries. We have specialized expertise in regulations and GxP standards, including:
21 CFR Part 11
21 CFR Part 820
Can you rapidly respond to changes in your environment while adhering to standards, creating traceability and managing risk?
SQA’s advisory experts work alongside your key personnel—Quality, Compliance and IT—to define, implement and govern quality policies and procedures related to the SLC:
Harmonize processes and tools while ensuring compliance
Automate flow and feedback loops wherever possible
Review and approve CSV deliverables
Define and adopt what works, across IT and Quality.
Rethink how to manage change and deliver business value with quality, reliability and speed.
Managing risk through FDA-compliant product development processes
SQA optimized Ivenix’s product development processes, supporting the organization’s commitment to continuous software quality improvement.
Are your IT change controls in check?
SQA helps define the workflows for the SLC, ensuring controls work efficiently and reliably. Our experts work with your team to:
Develop a full breadth of policies and procedures
Define IT change controls
Develop SOPs for CSV
Provide technical writing support for quality system enhancements, deviations, CAPA and project deliverables (work instructions, training documentation).
The ultimate outcome is improving your process for delivering quality systems.
COMPUTER SYSTEM VALIDATION
Need help creating CSV deliverables that adhere to internal quality requirements as well as FDA regulations?
SQA’s resources leverage thorough knowledge of global regulatory requirements for CSV. Our consultants work with your team to:
Conduct an impact or risk assessment
Create a validation strategy that aligns to both regulatory and business needs
Create and maintain a traceability matrix
Create and document validation/test scripts
Dry run validation tests
Coordinate test execution and UAT
Create a validation summary report.
REGULATED SOFTWARE TESTING
What will your customers ask you regarding testing processes, evidence, IQ/OQ, test scripts?
As a product vendor serving the heavily regulated life sciences industry, your customers demand validation of your product to satisfy FDA mandates. SQA can work with your team to improve software delivery velocity and be ready for customer audits. Our expertise includes:
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