Chemicals

Integrated Quality Management Software for compliance with EPA regulations, cGMPs, OSHA requirements, REACH and ISO standards

Chemical manufacturers are subject to a wide-range of regulations and standards and the regulatory pressures appear to be increasing with the recent passage of REACH in the European Union and the initiatives begun in the US Congress to modernize the 33-year-old Toxic Substances Control Act (TSCA) as well as recent EPA regulations of emissions from stationary sources. Meeting these standards is a challenge, especially in an environment of rapid growth and increasing customer demand and quality regulations.

What Can MasterControl Do for You?

MasterControl, Inc., a provider of document control and process management software solutions, provides chemical manufacturers with the automated tools needed to streamline document control and process management (out-of-specifications, training, audits, customer complaints, deviations, nonconformance events, change control, CAPAs, etc.) with one integrated web-based system.

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Quality Challenges

Chemical manufacturers face a balancing act every day. The balance between profit and production of the best (and least harmful) products available can indeed be hard to achieve. When it comes to quality, chemical companies also face the following challenges:

  • High Costs: Quality systems can be expensive so it's common for chemical facilities to maintain separate systems at their respective locations. This "ad-hoc" system often results in gaps where information can be lost or compromised. An ad-hoc system–in the long run–also costs a company more due to lost information, communication errors, slower process completion times and increased deviations, nonconformance events, etc.

  • Search and Retrieval Issues: In terms of documentation one of the main problems experienced in a regulated chemical industry environment is the difficulty in retrieving important documentation quickly and efficiently. SOPs, quality manuals and other essential documentation are documents that chemical professionals can't afford to compromise. Chemical companies are in great need of document version control, audit trails, reportable data and highly secure and easily accessible documentation. This of course is not available with an ad-hoc system and is certainly not available when documentation is "controlled" manually.

  • Inefficient System: Ad-hoc and paper-based systems are far too inefficient to handle task-heavy processes such as customer complaints, change control and CAPA processes. These processes are iterative in nature and need to be tracked and audited automatically for best results.

  • Poor Turnaround: Every process turnaround time makes a difference when it comes to getting a product to market or to its next stage of manufacturing. It's important to reduce turnaround time at every step of every essential process. For this reason, MasterControl has hired experts to research and develop state-of-the-art solutions for compliance and product lifecycle management.

Benefits of Compliance

An effective compliance system can track and manage incidents so that they can be resolved and closed at a faster rate. It can also help ensure that employees are trained in regard to relevant safety procedures as well as ensure documents are properly controlled and can be easily located. However, compliance can result in more than quality; it can result in greater profits when it's strategically planned and managed. Compliance with certain regulations and standards also raise compliant chemical companies to a new level relative to their competition.

詳細

To learn more about MasterControl's solutions and validation services, please contact a MasterControl representative.

About MasterControl

マスターコントロールは、規制対象の企業が、全体のコストの低減を図り、社内の業務効率を高めながら、自社の製品をいち早く市場に投入するうえで役立つソフトウェアソリューションを開発しています。マスターコントロールは、製品ライフサイクル全体を通じて、企業の重要な情報を安全に管理します。弊社のソフトウェアは、導入、バリデーション、使用が容易であることで知られています。マスターコントロールのソリューションには、品質管理文書管理製品ライフサイクル管理監査管理トレーニング管理文書管理部品表サプライヤー管理申請管理などがあります。業界のベストプラクティスに基づいた数々の広範なサービスを背景に、マスターコントロールはお客様の企業全体における完全な情報管理を実現します。