The concept of a pharmaceutical document control system is closely intertwined with quality control, an integral principle found in the current Good Manufacturing Practice (cGMP) regulations that apply to the pharmaceutical industry. The guidelines in 21 CFR Parts 210 and 211 require the establishment of a quality control unit responsible for approving or rejecting all procedures and specifications that affect the quality of a drug product. Specifically, 21 CFR 211.22 provides that the responsibilities and procedures applicable to the quality control unit shall be in writing. Additionally, it stipulates that these procedures must be followed. Within such a quality system, written procedures must be followed and deviations from them need to be justified and documented.
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The 21 CFR Part 11 standard works in tandem with other predicate rules (such as 21 CFR 210-211) that require document and other similar controls. Pharmaceutical document control software systems help streamline these quality processes.
In an increasingly technology-reliant industry, the importance of pharmaceutical document control software systems is undeniable. To control quality according to regulatory guidelines, a company must adequately control quality documentation. Controlling quality documentation requires an effective document control system.
MasterControl Documents™ is an advanced pharmaceutical document control software system that seamlessly integrates with the entire family of MasterControl quality management software solutions. It is a configurable and easy-to-use software solution that helps pharmaceutical companies attain and sustain cGMP compliance.
We recognize the importance of validating pharmaceutical document control software systems and understand that companies need to be able to keep their systems in a continually validated state to sustain FDA compliance. MasterControl offers full-cycle validation, including IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification) validation protocols and services. MasterControl continuously develops new methods to cut the time involved in validating a pharmaceutical document control system and to make it easier to validate software upgrades, both of which are essential in lowering the overall cost of software ownership.
Below is a listing of some of the typical document control pains common to compliance and evidence of some of the ways MasterControl pharmaceutical document control software systems address major compliance challenges.
CGMP Pharmaceutical Document Control Challenges
MasterControl Documents Software Solution
Inefficient Paper-based Document Control System
Paper-based document control systems are prone to lost and out-of-date documents. Paper SOP binders for employees are time consuming to control and keep accurate when changes occur. Getting new and updated documents approved can be time consuming, especially if approvals come from managers at other locations, and lost documentation can occur. Reporting on document changes is a tedious, manual process. Manually searching for and retrieving documents during FDA inspections or quality audits can also prove difficult.
Efficient Document Control System
MasterControl's pharmaceutical document control software system automates the routing and delivery of SOPs, policies, and other documentation to all managers and other employees. It is built to accept all types of files, no matter what software was used to generate them. Search and retrieval of documents is easy with simple and advanced search options, as well as customizable file Explorers. Reporting is easy with MasterControl’s report templates that can be used as is or configured according to individual needs. With change control and audit trails, it is easy to keep track of who changed what and when. The system is web-based, making it easily accessible to all authorized users.
Lack of Document Revision Control
In a paper-based or paper-electronic hybrid system, version and revision control can be difficult to control. To make changes, employees must check out documents and other materials (engineering drawings, etc.) manually. Tracking down what changes were made and by whom is difficult. Collaboration on document and SOP changes often requires face-to-face meetings with all the involved parties.
Automated Document Revision Control
MasterControl's pharmaceutical document control software system provides automatic revision control and version control. Old versions of documents are automatically archived until needed. Changes can be initiated and approved electronically, and change and audit trail functionality is built in.
Disconnected Document Control Processes
Communication breakdown is likely to happen when companies rely on paper processes that are different across different departments, divisions, and facilities. Sometimes even different people in the same department can manage a process differently. It is difficult to identify these differences in a timely manner, and even more difficult to get everyone using the same process.
Automated Document Control Processes
MasterControl's pharmaceutical document control software system allows companies to customize approval, collaboration, and escalation routing based on document types, ensuring all documents go to the right place every time. If documents aren't approved in a timely manner, the escalation function activates and notifies managers to take action. Because all departments, divisions, and facilities are using the same integrated system, there are no more worries about disconnected processes.