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 is an advanced document control solution that meets the needs specific to the biotechnology industry. Our biotechnology document control software systems are only part of the suite of quality management software solutions that includes training management, CAPA, customer complaints, risk analysis, project tracking, and more.
Biotechnology document control software system helps biotech companies automate, manage, and track electronic SOPs through the approval process to attain and sustain CGMP and other regulatory compliance. MasterControl Documents offers comprehensive, full-cycle validation, including IQ, OQ, and PQ validation tests.
Here's how MasterControl biotechnology document control addresses some of the major challenges that biotechnology 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 can require enormous man-hours routing documents, tracking down approvals, having meetings to collaborate, and retrieval of documents during inspections or quality audits. Companies with multiple locations either have disconnected processes, or spend extra time trying to remain on the same page.
|Efficient Biotechnology Document Control System
MasterControl Documents automates routing and delivery of SOPs, policies, and other documentation. As a web-based system, it can provide a centralized document repository for all departments and facilities. It can handle documents regardless of the system used to create them, while providing security controls for access, printing, and editing of those documents.
|Lack of Documentation Revision Control
In a paper-based or hybrid system it can be difficult to track down and replace old documents when revisions are made. 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 through the system. Changes can be notated in the system 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 documents, or you can disable printing to ensure that only the most current document can be accessed.
|Disconnected Documentation Control Processes
Communication breakdown is much more likely in companies that rely on different 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 Training with Document Control Processes
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. For example, new document revisions can trigger email notifications or training, customer complaints can be used to trigger CAPAs, or audits can be used to trigger risk analysis or CAPA forms.