Pharmaceutical Transition to GxP Software


MasterControl offers a white paper on the FDA's ongoing campaign to get all pharmaceutical companies onboard using quality management software.

MasterControl offers a white paper on the FDA’s ongoing campaign to get all pharmaceutical companies onboard using quality management software.

White Paper from MasterControl Pharmaceutical Transition to GxP Software

This white paper focuses on the FDA’s campaign to get all pharmaceutical companies onboard using quality management software (QMS) i.e., integrating document control with CAPA, deviations, change control, training, audit management, customer complaints, etc.

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White Paper: The Pharmaceutical Industry's Transition to Electronic Processes
White Paper: Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
White Paper: How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
White Paper: Top 5 Trends in the Pharmaceutical Industry in 2015
Case Study: Teva Pharmaceuticals
Case Study: Sorenson Medical
Product Data Sheet: MasterControl Training™



How does Pharmaceutical Transition to GxP Software work?

MasterControl document control software serves as the basis for all other MasterControl solutions. MasterControl Documents allows pharmaceutical companies to save time and effort by automating the creation and routing of documents, as well as their escalation and approval. The centralized, web-based document control solution ensures prompt access to the most current version of all documents, and can be complemented by additional quality management solutions, for example:

  • MasterControl Projects
  • MasterControl Electronic Submissions
  • MasterControl Validation Services
  • MasterControl Transfer OQ

Pharmaceutical Transition to GxP Software Validation Services

When you read the MasterControl pharmaceutical white paper about the FDA’s campaign to get all pharmaceutical companies onboard with quality management software, you’ll also learn about the FDA’s CFR 21 Part 11 regulation, which specifies that all automated systems must be validated. MasterControl provides customer training on how to provide continuous validation that includes hands-on activities on aspects of IQ, OQ and PQ. MasterControl also provides validation services for companies who don’t want to perform software validation on their own.

Pharmaceutical Transition to GxP Software Automation Benefits

Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments also presents the multiple benefits associated with quality and compliance process automation. These benefits include the following:

  • Streamlined Audit Processes
  • Improved Communication Between Management and CROs
  • Streamlined Complaint Handling
  • Streamlined Corrective and Preventive Action Management
  • Streamlined Change Control Management
  • Streamlined Training Processes
  • Pharmacovigilance Issues Resolved Quickly
  • Harmonization of PV Auditing Procedures, etc.

Contact MasterControl for Pharmaceutical Transition to GxP Software

Contact MasterControl for more information on pharmaceutical transition to GxP Software.