Build continuous compliance and auditability
across the systems lifecycle.

Quality
Management

f

SLC
Development

Z

Computer System
Validation

R

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.

QUALITY MANAGEMENT

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.

CASE STUDY

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.

Focus:

  • Product Design Reviews
  • Process Improvement
  • Risk Management
  • FDA Compliance

SLC DEVELOPMENT

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.

Looking for guidance?

SQA’s advisory experts help define, implement and govern quality policies and procedures related to the SDLC.
Contact Us

Need skilled resources quickly?

Connect with SQA and access our extensive network of Quality IT, validation and compliance consultants.
Contact Us

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 industy, your customers demand validation of your product to satisfy FDA mandates. SQA has worked with dozens of biotech, medical device, and pharmaceutical firms and understands FDA pressures and requirements.

And having worked with numerous highly nimble software engineering organizations we can help you achieve rapid software delivery with increased reliability through “shift left” testing, automation and CI/CD.

Be audit ready.

SQA has worked with dozens of biotech, pharmaceutical
and medical device companies for nearly 20 years.

Abbott
Alkermes
Applied Biosystems
Ariad
Bard Access Systems
Bayer
Biogen
Boston Scientific
Cure Forward
Daiichi Sankyo
DrugDev
ERT
IDEXX
Ivenix
m2s
Medtronic
NxStage
Parexel
Pfizer
Preventure
Roche Diagnostic
Sunrise Labs
Vertex Pharmaceuticals
Waters

We’d love to work with you, too.

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