Automating Life Science Business Processes


White Paper for Automating Life Science Business Processes to Ensure Compliance with FDA Regulations

Compliance with FDA regulations is part of doing business for life science companies. Regulations exist to protect consumers and the public in general. They are a major driving force for companies to manufacture and sell products (or provide services) that are safe, reliable, and effective.

Automating Life Science Business Processes by MasterControl Ensures Compliance with GxP Requirements

Since 1993, hundreds of companies in a wide range of regulated industries have relied on the MasterControl™ integrated quality management suite to attain and sustain compliance with FDA regulations such as:

  • 21 CFR Part 11
  • 21 CFR Parts 210 - 211
  • 21 CFR Part 820
  • 21 CFR Part 606
  • ISO 13485

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Clinical and Laboratory Quality Challenges in Automating Life Science Business Processes

A laboratory's ultimate goal is to ensure the accuracy and quality of tests. To achieve this goal, the lab must address many challenges, including:

  • Inefficient Quality System: Labs with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring a tremendous amount of man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during inspections.
  • Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation.
  • High Cost of Validation: High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a lab successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.

MasterControl Integrated Quality Management Software Solution for Automating Life Science Business Processes

Compliance is a state, not an event. A laboratory must not only attain compliance, but sustain it year after year. The MasterControl™ integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.

Recognizing that validating a software solution and keeping it in a constant state of validation is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

In this question-and-answer article, MasterControl Inc. interviewed a CDER official who discussed:

  • Most common reasons why pharmaceutical companies receive a Form FDA-483;
  • Things that investigators look for in terms of training and training control;
  • What investigators look for when evaluating a CAPA system;
  • What companies should do to prepare for a GMP inspection;
  • What companies should do when they receive a Form FDA-483; and
  • Top three areas that FDA investigators are trained to focus on during GMP inspections.

About MasterControl's Automating Life Science Business Processes

The MasterControl™ integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance. MasterControl connects different departments with each other and with data and processes under a secure and centralized web-based system. This connectivity helps promote quality throughout the enterprise by allowing management to continuously monitor and proactively improve the quality processes. MasterControl helps pharmaceutical companies meet key CGMP requirements and ISO quality standards, and at the same time increase efficiency and keep compliance costs down.

Learn More About Automating Life Science Business Processes

To get quality software solutions from MasterControl regarding automating life science business processes, feel free to contact a MasterControl representative today.