Change Control Software – MasterControl

Manufacturing Recipe Management Software

What is Change Control Software?

The utilization of this software is crucial in regulated sectors like life sciences and manufacturing, as it plays a vital role in ensuring adherence to regulations and effective management of alterations. This software enables businesses to efficiently tackle the intricacies of change control while optimizing their processes.

  • "Document change control" covers document management/control and rigorous documentation in regulated environments.
  • Businesses utilize this software to manage these processes effectively.
  • The software enables tracking, data collection, and approval facilitation for changes.
  • It offers a centralized platform for controlled change management across the organization.
  • This ensures regulatory compliance and risk reduction.
  • This software helps regulated companies adapt while staying compliant.
  • It aids in navigating change intricacies and industry regulations.

Why Change Control Software?

This software is indispensable in guaranteeing adherence to regulations and effectively handling alterations within regulated sectors like life sciences and manufacturing.

  • Using Document Change Control Software for Document Management

    • This software's global use for compliance with various regulations
    • Emphasis on FDA requirements in many software systems
    • Notable relevance of document management in FDA regulations (e.g., 21 CFR 211.100 for pharmaceutical firms, 21 CFR Part 820 Subpart M for medical device firms)
    • Additional adherence to global quality standards like ISO 13485 and ICH Q10
    • Rising reliance on this software by regulated companies
    • Need to recognize shared concern across regulations: proper documentation of quality-affecting processes
    • Focus on controlled documentation to ensure product safety
    • Core motivating factor for regulated firms using document change control systems
  • Using Document Change Control Software for Change Control

    • Companies using this software often manage documents and change control together.
    • Regulations like FDA guidelines emphasize the importance of change control (21 CFR 211.100 for pharmaceutical firms, 21 CFR 820.70 for medical device firms).
    • Document change control systems help regulated companies meet change control requirements in global standards (ISO 13485, Section 7.3.7; ICH Q10, Section 3.2.3).
    • Picking software: Insufficient change control opens risks of regulatory and product liability consequences.
  • Web-Based Platform

    • Th software provides a centralized hub for compliance documents.
    • MasterControl offers a singular access point for essential documents.
    • MasterControl is web-based, ensuring 24/7 access from anywhere for authorized users.
  • Mobile Access

    • MasterControl allows users to access the system via tablet or smartphone.
    • This advantage sets it apart from other systems.
    • Particularly beneficial for clean room and manufacturing floor workers.
    • Also useful for field workers and frequent travelers.
    • Enables participation in document-based processes from remote locations.
    • Users can engage in tasks without needing office computers.
  • Explorer

    • This software offers a user-friendly tool named Explorers.
    • Explorers enable effortless document search and retrieval.
    • Users can establish distinct Explorers for various document types.
    • Each department can structure document organization according to their preferences.
    • The tool enhances document management efficiency and accessibility.
  • Best-Practice Form

    • Supplies a ready-made form that streamlines the gathering and monitoring of data during the change control procedure.
  • Analytics and Reporting

    • This software enhances transparency in the change control process.
    • Utilizes standard and personalized reports to summarize change orders.
    • Reports offer insights by categorizing changes by product, department, root cause, and more.
  • Revision Control

    • Document change control systems are closely examined by regulatory agencies, focusing on revision control functionality.
    • MasterControl offers automated revision history, encompassing change rationales, approval dates, approver identities, and their signatures.
    • This feature ensures compliance with regulatory scrutiny.

Change Control Software Dealer/Reseller

Factonity Systems Pvt Ltd is a full service dealer & reseller of this software. Apart from software licensing, we also provide authentic software training, local technical support and statistical consulting.

Please contact us for:

  • Latest software pricing information / quotation
  • Demo of this software and free initial consultation
  • Lean Six Sigma + Change Control software bundled training with licensed of demo software
  • Post sales local technical support

Who uses Change Control Software?

MasterControl is utilized by numerous global companies to mechanize essential business procedures and the management of documents. This employment of MasterControl fosters teamwork, enhances the process of making informed choices, and expedites the speed at which products are brought to the market.

Which industries use Change Control software?

Leading corporations utilize this software. Below are a few industries that leverage the capabilities of this software:

  • Medical Equipment Manufacturing
  • Biotechnology Research
  • Chemical Manufacturing

Change Control Software