Quality Management System Consultant | Life Science / Healthcare

Areas of Expertise

Governance
Our team uses detailed internal standards and policies to manage the availability, usability, integrity and security of data management systems.
Strategies
Management systems don’t live in a vacuum. Our team helps your business implement data to make informed decisions and improve strategic planning.
Integration
Our proficient team integrates both internal and external systems to create consistent streams of information to track operations and performance.
Warehousing and Management
We capture data from a variety of sources to be used by your business analysts, while managing processes that ensure proper application performance.

Frequently Asked Questions

How do you determine the intended use of Computer Software Assurance?

According to FDA guidance, a life sciences manufacturer must validate computer software with documentation to determine its intended use according to an established protocol. Validation is required for any software that is used in any part of production or within a quality management system.

Learn more about using Computer Software Assurance for life sciences compliance.

What is the difference between Computer Software Validation and Computer Software Assurance?

CSV and CSA were both designed for regulated life sciences companies to ensure a computer software is working according to its intended design. CSA takes this process one step further as a risk-based approach that focuses testing on the functions of software that directly impact product quality and safety.

Learn more about the difference between Computer Software Assurance and Computer Software Validation.

Our systems are faster & more reliable than ever.

Experienced, Professional and Responsive

"Dayspring provided experienced, professional and responsive support for an IT quality project. Dayspring staff are well versed in FDA IT-related regulations/guidance and applicability."

- Sr. Director, Quality Management

Our systems are faster & more reliable than ever.

Professionalism and Insight

"Dayspring Technology’s professionalism and insight allowed our organization to effectively manage and maintain our ISO 27001, PCI DSS, and SOX programs."

- Barbara, Systems Security Analyst, Global Insurance Firm

Management Systems

MANAGEMENT SYSTEMS.

Mature security and quality management programs.

Areas of Expertise

Governance

Strategies

Integration

Warehousing and Management

Frequently Asked Questions

How do you determine the intended use of Computer Software Assurance?

What is the difference between Computer Software Validation and Computer Software Assurance?

Challenge us

With What's Challenging You.