Improving Laboratory Processes


Automate Paper-based Clinical or Medical Laboratory Quality Processes and Comply with CLIA, CGLPs, CGMPs, and Other FDA Regulations

Clinical labs must comply with the Clinical Laboratory Improvement Amendments (CLIA) to be certified to perform testing on human specimens. Labs involved in development of new tests and technologies and in clinical studies also must comply with FDA regulations. FDA-regulated labs maintaining electronic record-keeping systems must comply with 21 CFR Part 11.

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Clinical and Laboratory Quality Challenges

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。

  • 非効率的な品質システム: 異なる場所に複数の施設と従業員を抱える研究所は、個別の品質システム、特に紙ベースまたはハイブリッドのシステムを保持するほうが安上がりであると最初に判断する場合があります。しかし、長期的には非効率で、SOPやその他の文書のルーティング、承認及び署名の取得、対面ミーティングでの意見交換、査察の際の手動による文書の検索及び抽出に膨大な工数が必要になります。
  • 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

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 interviewed a CDER official who discussed the following:

  • 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
  • Top three areas that FDA investigators are trained to focus on during GMP inspections

Call Today for Software Solutions About Improving Laboratory Processes

To get more details and software solutions regarding improving laboratory processes, feel free to contact MasterControl representative today.