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Pharma, BioTech,

& Labs


Intellect Pharma, Biotech, & Labs

Pharmaceutical, biotechnology and laboratory industries are challenges with some of the most complex and scrutinized regulations, while also facing competitive pressures to succeed in the global marketplace.


Enabling Compliance

Intellect can help enable your organization to effectively comply with 21 CFR Part 11, GxP, and other industry standards and regulations. Intellect offers a comprehensive and highly configurable QMS solution for pharmaceutical, biotechnology and laboratory organizations.




Medical Device manufacturers must use the appropriate documentation that adheres to the standards provided by the Food and Drug Administration’s (FDA) guidelines. Intellect offers a highly flexible software solution for the automation of the design process for all medical device manufacturers.


Drug Safety

Intellect can help standardize and automate processes for drug safety reporting to meet compliance and to improve operational efficiency with a highly flexible workflow automation solution.

With Intellect, organizations can manage and track all communications concerning product registrations, submissions, and commitments to health authorities.


Learn How Intellect QMS Complies with the Pharma, Biotech, & Lab Industries

CFR Prt 11 CPG

Does Your QMS Comply with 21 CFR Part 11

21 CFR Part 11 Compliance ensures that companies and organizations implement good business practices by defining the criteria under which electronic records and signatures are accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper.




How Intellect QMS Meets FDA Requirements

Download our brochure and learn how Intellect's Quality Management System Software meets specific FDA Requirements. Intellect’s hyper-adaptive Quality Suite lets you leverage regulatory and standards compliance into improved business results especially in the Pharma, Biotech, and Labs industries.