Build continuous compliance and auditability
across the systems lifecycle.
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.
Can you rapidly respond to requests and changes in your environment?
SQA’s advisory experts work alongside your key personnel—Quality, Validation and IT—to define, implement and govern quality policies and procedures related to the SDLC:
Harmonize processes and tools while ensuring compliance
Automate flow and feedback loops wherever possible
Define and adopt what works, across IT and Quality.
Rethink how to 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.
- Product Design Reviews
- Process Improvement
- Risk Management
- FDA Compliance
Are your IT change controls in check?
SQA helps define the workflows for the SLC, ensuring controls work efficiently and reliably.
Our experts develop the full breadth of policies, procedures and controls, including defining IT change controls and developing SOPs for CSV.
The ultimate outcome is improving your process for delivering quality software.
COMPUTER SYSTEM VALIDATION
Need help ensuring CSV deliverables adhere to internal quality requirements as well as FDA regulations, including 21 CFR Part 11?
SQA’s resources leverage thorough knowledge of global regulatory requirements for CSV, including the FDA’s 21 CFR Part 11. Our consultants work with your team to:
Provide quality oversight around CSV and Change Control
Create, revise and implement documentation to support computer systems operations
Ensure CSV deliverables (PQ validation, protocols, etc.) adhere to regulations as well as internal quality requirements
Identify issues and provide guidance on CSV requirements
Develop and support procedures and work instructions.