SOP Writing - Standard Operating Procedure Writing

MasterControl's SOP Writing Systems are designed by industry practitioner for automating the SOP writing process in any organization. A Standard Operating Procedure Writing system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated SOP Writing system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.


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Educational Materials

Get insider information about the most relevant issues in SOP Management today, and how to navigate and overcome the complexities of FDA and ISO Compliance.

Product Data Sheets
Free Templates
  • This editable and customizable standard operating procedure (SOP) template provides a framework for consistently and thoroughly documenting your policies to help you meet regulatory requirements.
  • This editable and customizable standard operating procedure (SOP) template provides a framework for consistently and thoroughly documenting your procedures to help you meet regulatory requirements.
  • This editable and customizable standard operating procedure (SOP) template provides a framework for consistently and thoroughly documenting your work instructions (WI) to help you meet regulatory requirements.
Product Data Sheets
White Papers
  • An SOP can be as simple as a checklist or as complex as a chemical manufacturing company's process of isolating and purifying an active pharmaceutical ingredient. This white paper delineates the various types of SOPs, discusses common SOP challenges, and shows how efficient quality management systems can streamline the management of a company's SOPs and, subsequently, the quality of its products
  • This white paper addresses the fundamentals of writing and enforcing SOPs not only in accordance with internal company policies and requirements but also in compliance with regulatory requirements such as those set forth by the FDA. It illustrates the importance of planning, drafting, reviewing, testing and auditing SOPs for maximum effectiveness and offers tips on how to develop new SOP skills
  • Learn how automated document control solutions help organizations better manage corrective and preventive actions (CAPA), change control, training, and many more quality processes. It focuses on document control processes within the quality system lifecycle and provides insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with regulatory requirements and improve overall profitability.

Product Information

Discover how MasterControl Document Control Software can manage your SOP Management process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • The MasterControl Documents™ software solution automates and effectively manages the document control process to help companies ensure compliance with regulatory requirements. It automates all document routing, delivery, escalation and approval processes and makes the search for and retrieval of documents easy during audits or inspections.
  • MasterControl offers the most complete choice of integrated solutions covering all core areas necessary to successfully maintain quality and compliance processes, as well as a variety of services based on industry best practices.
Product Data Sheets
Consulting Services
  • MasterControl Quality and Compliance Consulting™ (QCC) offers intensive one- and two-day quality process workshops designed to help you stay one step ahead of even the most complex developments. The training is relevant regardless of the electronic quality management system (QMS) solution you use, or even if you do not have an automated system in place.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your Document Control program.

Product Data Sheets
Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
Product Data Sheets
Toolkits
  • MasterControl's experts have invested more than 300 hours into the development of this Document Control Toolkit that provides all the materials a company needs to start on the path to establishing a streamlined, robust document management system. Includes 3 videos, 3 white papers, 2 data sheets, and 1 interactive graphic.


About MasterControl Standard Operating Procedure Writing


Since 1993, MasterControl has been at the forefront of the process and document management industry. MasterControl takes great pride in offering a standard operating procedure writing system that goes beyond software to provide real solutions to real challenges. As the first company to create a process and content management system that directly addressed the unique needs of companies within the FDA and ISO regulated environments, it is no wonder over 900 companies around the world turn to MasterControl technology while SOP writing and seeking to sustain regulatory compliance.


Ensure Compliance by Standard Operating Procedure Writing


When regulated companies begin SOP writing for their processes and procedures, they must also take into account industry best practice guidelines. Standard operating procedure writing that follows these guidelines helps companies ensure that employee job performance is compliant, manufacturing procedure is compliant, and training processes are compliant.

MasterControl's integrated electronic content and process management system keeps all of the standard operating procedure writing, documentation and quality control processes current and compliant. MasterControl's suite includes the following integrated, easy-to-use applications that can be configured to meet the unique software solution needs of each company:

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


For More Information on SOP Writing


Those responsible for standard operating procedure writing must be familiar with current FDA and ISO regulations. MasterControl's Resource Center is a comprehensive site built to inform and educate. At the Resource Center, regulated companies can find educational and research materials about FDA and ISO regulations, industry current events, and electronic quality management systems. These materials include industry white papers, tech papers, case studies, and product data sheets.

Questions About SOP Writing? Contact MasterControl Today


To learn more about SOP writing from MasterControl, please feel free to contact a MasterControl representative.

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