Data-Driven Quality Management For Growth-Oriented Life Science Companies
Make quality management decisions faster than your competitors without worrying about GxP regulatory compliance. Connect your people, process, technology, and product data using our expertise in no-code/low-code applications and automation tools.
Context is everything
Never worry about your data relationships
Simple to adopt and maintain
Make data-driven decisions
Remain compliant by design
Create interfaces with ease
The right QMS framework is the difference between a company worrying about quality issues and a company that gets products to market faster.
The Way It is for most regulated companies
The hidden costs of poor quality management are not worth it
Your quality management efforts help you see only part of the QMS picture, even though you've implemented all the right systems and processes.
You invest time in maintaining your current QMS but always find it’s missing something.
Are you experiencing these frustrations?
- → The constant pressure to reduce costs.
- → Frustrations with accessing data in many places.
- → Low-value-added work due to a reactive mindset.
- → Inflexible processes that don’t support critical thinking.
- → No common understanding of your organization's processes.
- → Restrictions on the use of advanced technology and automation.
You deserve a customized QMS framework with end-to-end data visibility beyond checking compliance boxes.
We help life science organizations design a fully customized QMS that uses speed, data, and connectivity to reshape daily quality work across the organization's value chain.
Build all the custom views, interfaces, reports, and dashboards you want by leveraging our expertise in no-code/low-code applications and automation tools.
Proven expertise with technology platforms you already use
Designed to help you do more with your QMS
Analyze data sources
Understand your QMS data sources, including systems, paper documents, and spreadsheets. When you know where all the data resides, you can ensure data integrity.
Unite your QMS elements
Stop wasting your time finding data. Rely on our expertise to bring your people, processes, and technology data under one view, so you can focus on making the right GxP decisions.
Capture the metrics you want
We help you create custom interfaces, automation, and visuals using off-the-shelf no-code tools; without writing code or relying on software developers.
Provide training and administration
We design training materials, user guides, and e-learning videos to form a consistent understanding of your QMS processes. Training also includes use of no-code and automation tools.
How we partner
Unleash the potential of your QMS in multiple ways to maximize value
QMS Build and Metrics
Implement a phase-appropriate QMS and train employees in your company. Design workflows to capture and report QMS metrics.
Computer Software Assurance
Select, test and deploy computer systems and supporting infrastructure. Manage release and change management activities.
GxP Regulatory Compliance
Oversee operations to ensure compliance with regulations and company policies. Conduct audits and gap assessments as needed.
Build a data governance model to ensure GXP data is recorded, processed, retained, and used to preserve data integrity.
Benefits of adopting a customized and scalable QMS framework
Don't just take our word for it; see what clients and industry professionals say
Senior Project Manager
“Qualtivate did a phenomenal job accommodating a last-minute software audit and provided us with a quick audit summary and recommendations.”
Senior Manager, Medical Affairs Operations
“I had the pleasure of working with Harsh on multiple projects. Harsh is easy to work with and will be an asset for any project teams in life sciences requiring understanding the business needs to present the right solution.”
Senior Director, Global Clinical Compliance and Quality
“I appreciate Harsh’s depth of knowledge in computer software assurance and his commitment to quality. He often challenges the status quo and explains his viewpoints in a pragmatic way that is easy to understand. Harsh is an invaluable asset to any organization to help foster a culture of data quality and integrity.”
Senior Manager, Quality Systems
“The team at Qualtivate is flexible, patient, and always puts their client’s needs first. They bring considerable subject matter expertise to Computer System Validation and Data Integrity projects.”
Head of Quality
“Harsh's knowledge of GxP computerized system setup and validation impressed me, as did his confidence and calm demeanor. Harsh's advanced education in Regulatory and Quality served him well in translating regulations to real-time use of various types of GxP software and applications.”
Managing Director, Bibby Consulting Group
“Harsh is in a league of his own regarding QMS systems. His commitment to customer service and expertise make him a market leader in his field. It's a 5-star recommendation from me.”
Senior Manager, Qualio
“Qualtivate partnered with Qualio for a webinar around eQMS. Harsh demonstrated his deep knowledge of eQMS expertise as a speaker. The audience benefited from his clear and concise presentation on the topic.”
“I had the pleasure of collaborating with Qualtivate on one of our training webinars at Qualistery. Harsh showcased his enormous eQMS deployment and improvement expertise. His skills as a keynote speaker are also commendable, mirrored in the great reviews that the hundreds of participants left.”
Sub-Investigator, Clinical Research Organization
“Qualtivate's dedication to leveraging technology to the fullest while ensuring compliance across every product development phase is exciting. It combines speed and flexibility for early-stage life science companies.”
let’s work together
Imagine how easy GxP decision-making would be if you could see the big picture of your QMS
It starts with a 30-minute call where we will:
- Discuss your QMS and compliance problems.
- Strategize how to overcome them.
- Share examples of client case studies and results.
- Talk about the tech stack of no-code and automation tools.
- Tell you about our pricing and approach to projects.
- Answer any other questions you have!
Raleigh, North Carolina (HQ)