Biotechnology Document Control Software Systems

Biotechnology Document Control Software Streamlines Compliance with FDA and CGMP Regulations by Effectively Controlling and Managing Required Documentation.

21 CFR 211.22 requires that quality control units have their policies and procedures in writing. Trying to control procedure documents on the manufacture, processing, package, and holding of biotechnology products with a manual process can be a daunting task. Using a 21 CFR Part 11 and 210-211-compliant biotechnology document control software system eases the burden of control and use of these documents.

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MasterControl Documents™: The Ultimate Biotechnology Document Control Software

MasterControl Documents is an advanced biotechnology document control software system that meets the needs specific to the biotech industry. MasterControl’s biotechnology document control software system is part of the holistic quality management software platform that integrates training management, CAPA, customer complaints, risk analysis, project tracking, and more.

MasterControl biotechnology document control software systems help biotech companies automate, manage, and track electronic SOPs through the approval process to attain and sustain CGMP and other regulatory compliance standards. MasterControl Documents offers comprehensive, full-cycle validation, including IQ, OQ, and PQ validation tests.

Here's how MasterControl biotechnology document control software systems address some of the major challenges that biotech companies face in establishing and maintaining a documentation control system that complies with FDA CGMPs, 21 CFR Part 11 and 210-211.

Documentation Control Challenges

Biotechnology Document Control Software Solutions

Inefficient Paper-based Documentation Control System

Manual biotechnology document control involves an overwhelming number of man-hours devoted to document routing, tracking down approvals, having meetings to collaborate, and documentation retrieval during inspections or quality audits. Companies with multiple locations either have disconnected processes or waste an inordinate amount of time trying to stay on the same page.

Efficient Biotechnology Document Control Software System

MasterControl Documents automates the routing and delivery of SOPs, policies, and other documentation. As a web-based system, it can provide a centralized, secure document repository for all departments and facilities. It can handle all file types, regardless of the system used to create them, while providing security controls for controlled access, printing, and editing of critical documents.

Lack of Documentation Revision Control

It is arduous to track down and replace old documents when revisions are made when using paper-based or hybrid systems. Changes require manual submission, approval, and tracking of change requests. Locating and pulling out old revisions of documents during a quality audit is a time-consuming process.

Automated Documentation Revision Control

Changes can be collaborated on and approved electronically via the MasterControl system. Changes can be notated to supplement the automatic change control functionality. Versions and revisions are updated automatically based on pre-defined numbering criteria. Old revisions are archived and security controlled. Printed documents can be watermarked to show expiration dates to help control paper copies, or users can disable printing to ensure that only the most current document is accessible.

Disconnected Document Control Processes

Communication breakdown and catastrophic misunderstandings are much more likely in companies that rely on dissimilar processes to manage a quality system. Ineffective communication can lead to delays and poor results, which in turn leads to lost revenue and potential negative audit findings.

Integrates All Quality Processes with Document Control

The MasterControl biotechnology document control software system is an integrated solution that connects all quality sub-systems like CAPA, change management, audit, customer complaint, and training. Document revisions made within the system can trigger email notifications or training tasks. Likewise, customer complaints can be used to trigger CAPAs and audits can trigger risk analysis or CAPA forms.

Biotechnology Document Control Software Systems Facts

  • MasterControl's biotechnology document control software system has been successfully implemented, validated, and inspected in FDA environments without any instances of non-compliance since its introduction more than two decades ago
  • 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
  • An off-the-shelf configurable product designed for rapid installation, implementation, and validation
  • Ensures documentation integrity so employees always have the most updated document at their fingertips

MasterControl Biotechnology Document Control Software System Core Capabilities

  • Combines powerful electronic routing and approval functionality
  • Full audit trail and reporting
  • Electronic signature management and control
  • Ensures 21 CFR Part 11 compliance with security and integrity of documents
  • Computer systems validation plan and implementation including validation-ready for IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification)
  • Scalable, open systems architecture
  • Supports industry-standard databases