Pharmaceutical Document Control Software Systems

MasterControl's Pharmaceutical Document Control Software Systems Ensures Compliance with GMP/GCP and 21 CFR Part 11, Part 50, Part 56, Part 210-211, and Part 312 Requirements

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.

Free Resources

Select all the resources you’re interested in downloading

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: The Ultimate Pharmaceutical Document Control Software 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 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.

Pharmaceutical Document Control Software System Facts

  • MasterControl's Documents module for pharmaceutical document control has been successfully implemented, validated and inspected in FDA environments without any instances of non-compliance since its introduction in 1998
  • Pharmaceutical software is a proven tool to speed up the process of brining a new product to market by increasing efficiency throughout the entire process
  • Is 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

Pharmaceutical Document Control Software Systems Core Capabilities

  • Automatic routing for approvals, collaboration, and escalation
  • Full change control with audit trails
  • Secure, electronic signatures meeting 21 CFR Part 11 requirements
  • Complies with 21 CFR Part 820.40 and ISO 13485 document control requirements
  • validation plan and implementation services
  • Validation-ready for IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification)
  • Scalable, architecture for small to enterprise level businesses