SOP Management - Standard Operating Procedure Management


Learn How Standard Operating Procedure ( SOP ) Management is a Compliance Tool for FDA GMP, GLP, GCP, and ISO Environments

Standard operating procedures management is commonly used across all industries to help companies operate safely and more efficiently. Properly managing SOPs for manufacturing companies that are ISO or QS/TS certified is mandatory. Within pharmaceutical, medical device, biotechnology, or other industries regulated by the FDA, SOPs must be managed with strict change control processes to assure proper compliance with current good clinical practices (cGCP), good manufacturing practices, (cGMP) and good laboratory practices (cGLP). Whether or not an industry imposes specific requirements, SOP management is to be done in a controlled manner and should be implemented as a standard business practice.

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How can MasterControl SOP Management Documents Benefit You?

Here's how MasterControl standard operating procedure management software addresses some of the major challenges that companies face in establishing and maintaining a document control system.

Document Control Control ChallengesMasterControl Documents Software Solution
Inefficient Paper-based Document Control System

Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid SOP management systems. In the long term, however, these systems are inefficient, requiring tremendous 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 FDA inspections or ISO audits.

Efficient Document Control System

MasterControl Documents automates routing and delivery of SOPs, policies, and other documentation. It's uniquely qualified to be the focal point of a standard operating procedure management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits. MasterControl Documents is Web-based so documents are accessible to all authorized users from virtually anywhere.

文書改訂管理の欠如

In a paper-based system or hybrid system, employees check out documents and other materials (engineering drawings, etc.) manually. Tracking down any document activity is difficult. Making a change in an SOP management system or other document requires manual submission of a change request or discussion of the change in face-to-face meetings.

Automated Document Revision Control

MasterControl provides automatic revision control to ensure that only the current version of a document is available. Changes can be initiated and approved electronically. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports. MasterControl Documents always ensure users are able to access the right document any time.

非連携の文書管理プロセス

Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. Ineffective communication can lead to delays and poor results.

Integrates Training with Document Control Processes

MasterControl SOP management is an integrated solution that connects all quality sub-systems like CAPA, change management, audit, customer complaint, and training. For example, a customer complaint that warrants a CAPA will be immediately escalated. Any CAPA that results into a change will automatically invoke training once the change is approved.

不十分な監視

It's difficult to generate accurate and timely reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders). Without an effective reporting tool, managers are unable to get control of their quality standard operating procedure management system.

Increased Management Viability

MasterControl provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the quality processes and can be more proactive about improving their quality system.

Standard Operating Procedure Management and Document Control Software Facts

  • MasterControl Documents has been successfully implemented, validated and inspected in FDA environments without any instances of non-compliance since its introduction in 1998
  • A SOP management system dramatically reduces the time it takes to bring a new product to market by speeding up the process for document change, approval, notification, and distribution
  • 迅速なインストールや導入、バリデーションを目指して設計されたカスタマイズ可能な市販製品
  • 文書の整合性が確保されるため、担当者はいつでも最新の文書をすぐに利用可能

Core Capabilities of Standard Operating Procedure Management

  • 強力な電子的ルーティングと承認の結合
  • Full audit trail and reporting is available for good sop management
  • 電子署名の管理
  • 文書の安全性と整合性に関する21 CFR Part 11コンプライアンスの徹底
  • コンピューターシステムバリデーション における計画及び導入:
  • Validation-ready for IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification)
  • 拡張性のあるオープンシステムアーキテクチャー
  • 業界標準のデータベースをサポート

Sustain Regulatory Compliance with MasterControl's Standard Operating Procedure Management Software

It is possible to move away from outdated, unconnected, inefficient standard operating procedure management practices. The electronic standard operating procedure software solutions are part of MasterControl's content management suite. The suite includes easy-to-use, fully integrated applications that can be configured to meet the unique needs of small, mid-size, and large companies. These applications include the following:

  • MasterControl Documents
  • MasterControl CAPA
  • MasterControl Training
  • MasterControl Forms
  • MasterControl Change Control
  • MasterControl SOP Management Audit
  • MasterControl Customer Complaints
  • MasterControl Nonconformance
  • MasterControl Submissions Gateway

MasterControl's suite helps companies establish compliant standard operating procedure management system so they are always ready for inspections and audits.