Life Sciences Overview

Helping You Maintain Compliance and Security
The Qualtrax team is experienced in working with leaders in Life Sciences to keep you competitive and ensure compliance with key regulations.

The financial risks due to noncompliance in the Life Sciences industries today are at an all time high. According to PhRMA (Pharmaceutical and Research Manufacturers Association), The risks of not having an effective, compliance driven document management solution are significant. The opportunity cost of a new blockbuster drug missing its launch date due to FDA compliance violation is $1 billion per day.

Qualtrax Benefits for Life Sciences:

Industry Needs	Qualtrax
Secure Electronic Signatures
Revision Control
Documented Audit Trail
Electronic GxP’s
Electronic GLP’s
Tamper-proof Document Control
Validation Protocols
Retention & Maintenance of Records
Automated Corrective/Preventive Action

FDA 21 CFR Part 11, 210 and 211 Compliance
Qualtrax has built-in features designed especially for FDA compliance. These include electronic signatures, site acceptance and validation services. Learn more about Electronic Signatures and Tamper-proof documents.

HIPAA Compliance
HIPAA compliance means all employees must understand these guidelines and proper HIPAA procedures. Qualtrax helps hospitals and other healthcare institutions maintain key HIPAA procedures and provides tools for ensuring employees are trained on these procedures. Learn more about Qualtrax Training Management.

Security
Qualtrax ensures that key specifications and testing data is not available to the public and that only the appropriate parties can view or modify critical procedures. Learn more about Qualtrax Document Control.

Third party and Customer Audits
We make audits easy. Qualtrax will help to ensure audit success with automated tracking and monitoring of procedures, product specifications and customer complaints. Learn more about Qualtrax Audit Management.

Document Imaging
No matter how you try to avoid it, paper-based documents and records still exist. Qualtrax can assist with the scanning and maintenance of your documentation to guarantee this information is maintained for the proper length of time and is secure. Learn more about Qualtrax Document Imaging.