Validation is required by the US FDA, ICH, and Eudralex, as well as the regulations of most advanced nations.

Each year the FDA issues hundreds of Warning Letters for quality violations.  For the Pharmaceutical, Biologics, and Medical Device industries, validation failures are among the most prevalent topics.

Creating complex products in the life science industry requires advanced know-how of manufacturing and supply chain science and technologies.  It also requires knowledge and active compliance with government regulations.

Our Validation Solutions and Services

Whether you need a little help or A LOT to achieve your validation and quality assurance project objectives, Praxis Life Sciences offers the products and services to get you there fast. 

• Consulting Services: Our compliance experts can lead you through the validation process.  We apply risk-based approaches to process, equipment, and computer systems validation and quality assurance to keep your operations efficient and your company compliant.

• Training: Whether you are new to computer system validation (CSV), or an experienced pro, Praxis offers CSV training and webinars to sharpen your skills.

• Templates: Validation Center™ provides a concise library of resources for the software quality professional. Visit to browse US and international regulations and guidance docuements.  Or, for only $500, obtain unlimited access to a full suite of computer system quality SOPs, validation deliverable templates, and software-related FDA Warning Letters.