Continuous Compliance

Build continuous compliance and auditability
to meet regulatory requirements with confidence.

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Quality Management

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SLC Development

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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

Annex 11

GCP

GLP

GMP

Data Integrity

QUALITY MANAGEMENT

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

  • Vendor audits

  • Define and adopt what works, across IT and Quality.

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Rethink how to manage change and 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.

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 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.

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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:

  • Continuous compliance

  • Shift left testing

  • Automation

  • CI/CD.

Be audit ready.

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

It’s Time to Adapt: QA & Test in a DevOps World

Agility and DevOps are transforming traditional SDLCs, forcing organizations to adapt. Leaders realize that realigning the people, processes and tools involved in quality assurance and test are required to deliver maximum business value.

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Myths & Misconceptions: 5 Things DevOps is Not

While an increasing number of companies are successfully implementing DevOps methodology, there are still pervasive misconceptions about DevOps.

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The Fundamentals of DevOps

IT organizations across the globe are embracing a DevOps approach, allowing companies big and small to deliver software with unprecedented frequency, reliability, and stability.

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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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