Pharmaceutical Document Control Software

Medicine Document Management

 

The pharmaceutical industry is one of the most regulated markets in business today. The FDA, EPA and other regulatory bodies are constantly adding quality requirements and cracking down with strict auditing schedules. Being prepared for these audits is one of the largest time consumers for a quality team. With ENSUR as your document management software for quality control, you’ll be able to quickly and easily satisfy auditor requests with a document master list, training records, training reports and revision history reports just to name a few.

Our experience with many pharmaceutical clients has crossed over into Laboratories, Biosciences and even Manufacturing/Packaging. Being able to accommodate all processes in one quality control software package makes ENSUR irreplaceable to the quality professional and industry market leaders. When you are looking for a document control solution such as software for quality control in the pharmaceutical industry, ENSUR operates as a comprehensive solution to be the one place for all your records. ENSUR helps you meet FDA requirements and regulatory compliance and is the ultimate quality tool in document management.

DocXellent helps you meet your key objectives:

  • Maintain FDA 21 CFR Part 11 Compliance
  • Speed to Market
  • Application of and validation of Electronic Signatures
  • Successful Software Validation using GAMP4 methods
  • Integrated Change Control
  • Document Security and Print Controls
  • Web Form Management and Data Extraction
  • Detailed document, revision and employee audit trails
  • Product Submission Preparation
  • Document Binding
  • Employee Training Management
  • Multi-department collaboration
  • Automated Notifications & Distribution
  • Study and Laboratory Data tracking and reporting