The concept of a pharmaceutical document control system is closely intertwined with quality control, an integral principle found in the Current Good Manufacturing Practice regulations CGMP, which apply to the pharmaceutical industry. 21 CFR Parts 210-211 require the establishment of a quality control unit that will be 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; such procedures shall be followed. Under a quality system, written procedures are followed and deviations from them are justified and documented. 21 CFR Part 11 works in tandem with predicate rules such as 21 CFR 210-211. It also requires document and other controls. Pharmaceutical document control software systems help streamline these processes.
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The importance of pharmaceutical document control software systems is undeniable. To control quality, one must control quality documentation. Controlling quality documentation requires an effective document control system.
MasterControl Documents is an advanced pharmaceutical document control software system is integrated with the entire MasterControl suite of quality management software solutions. It is a configurable and easy-to-use software that helps pharmaceutical companies attain and sustain CGMP compliance.
We recognize that the validation of pharmaceutical document control software systems and being able to keep it in a constant state of validation is an important part of sustaining FDA compliance. MasterControl offers full-cycle validation, including IQ, OQ, and PQ 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 validation.
Below we show how our pharmaceutical document control software systems addresses some of the major challenges that pharmaceutical companies face when establishing systems that comply with FDA CGMPs and 21 CFR Part 11.
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Paper-based document control systems are prone to lost and out-of-date documents.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 with any changes. Getting new and changed 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. Manual search and retrieval of documents during FDA inspections or quality audits can also prove difficult.
Efficient Document Control System
MasterControl's electronic pharmaceutical document control software automates 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 easy with simple and advanced search options, as well as customizable file organizers. Reporting becomes easy with the sample of canned reports, or by using the easy-to-use wizard. 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 systems, version and revision control can be difficult to control. In order to make changes, employees must check out documents and other materials (engineering drawings, etc.) manually. Tracking down what changes were made and by who is hard. Collaboration on document and SOP changes often requires meetings of 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 departments 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 to notify managers to take action. Because all departments, divisions, and facilities are using the same system there are no more worries about disconnected processes.