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

研究所の最終目標は、試験の精度と品質を確保することです。この目標を達成するには、研究所は次のような様々な課題に対処する必要があります。

  • 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.
  • コストのかかるバリデーション: 21 CFR Part 11では、電子記録及び電子署名の完全性を確保する手段としてコンピューターシステムバリデーションが義務付けられています。手動の記録保持システムを自動化している場合でも、研究所は厄介な作業やコストのかかるバリデーションに直面します。多くの労力を要するバリデーション試験を社内スタッフが実施することに加え、法外なコンサルタント料金がかかることで、企業のコンプライアンスコストはすぐに倍増する可能性があります。

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.