Manufacturing companies perform functions that are usually written down either manually or electronically. FDA regulations require companies to manage documentation such as Standard Operating Procedures (SOPs), Design History Files (DHF), Batch Records, and employee training records. Many companies are now relying on document control software to ensure product quality and safety.
FDA regulations require GMP document control measures to ensure the integrity of SOPs, documents in the Design History File (DHF), batch records, employee training records, and similar documentation. The lack of GMP document control accounts for the majority of FDA Form 483s. MasterControl's GMP document control software provides companies with the ability to manage GMP documentation efficiently and effectively while maintaining compliance.
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MasterControl Documents is an integrated part of the MasterControl quality management suite. MasterControl's GMP document control software system automates all electronic document management processes to bring compliance and conformity in the system.
Benefits of implementing an electronic document management software solution include:
MasterControl's electronic system for GMP document control is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of electronic documents regardless of the software used to create them. All documents, irrespective of their type, are stored in a local, centralized repository that is easily accessible by any authorized user across the globe.
As MasterControl's GMP document control software is web-based, it can connect all employees involved in document and quality control from virtually anywhere. The centralized repository accommodates authorized users for easy access, search, and retrieval of electronic documents. MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use tool for GMP document control that helps users find and access documents quickly. Every department can maintain its own explorers and documents can be stored in multiple explorers. Also, system administrators can control and automatically update documents.
Manufacturing companies run the risk of producing product batches that are based on out-of-date versions of SOPs. This can lead to a serious non-comformity in the system as well as loss of capital for the organization. To avoid such situations, MasterControl's GMP document control system provides automatic document revision control to ensure that only the current version of an SOP is available. The solution prompts the user to enter a reason for any changes before making updates. Moreover, documents are tracked either by status or history. A document will show as either "in process" or "complete" if tracked by status. Revisions and approval histories of electronic documents can also be reviewed using the history feature.
One of the concerns for any company is to ensure that the integrity of documents is maintained. Any leakage of company secrets can lead to serious consequences. 21 CFR Part 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies. MasterControl ensures GMP document control by securing all documents in virtual vaults located in a central database. The MasterControl system automatically locks both login and approval anytime either one is compromised.
Apart from this, the MasterControl GMP document control software provides a secure, time-stamped audit trail that meets and even exceeds 21 CFR Part 11 requirements. The MasterControl software solution is proficient in recording details such as the identity of the user creating or modifying the electronic record. The timestamp records when exactly an action occurred and what changes were made.
Most companies want to ensure that the documents are properly signed off by managing reviewers. With MasterControl GMP document control, electronic documents can be signed and approved automatically. Electronic signature manifestation, name, date, time, and meaning of electronic signature, can be appended automatically to each document.
The success of any manufacturing company relies on how good they are at understanding the underlying statistics. Most companies recognize the importance of generating reports that correctly reflect the productivity of the business in a timely manner, but are reliant on disparate tools to generate such reports. MasterControl's GMP document control system uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight. This helps managers and executives understand the dynamics so they can focus on weaker areas of the business.
Many employees find the process of creating and revising documents a difficult task. It is not always possible to manage people on the same page. However, effective GMP document control software is all about providing users with a collaboration workspace that allows every user to see other people's input. This factor makes it easier to automate the routing, escalation, and approval of documents. Instead of delays in reviews, MasterControl GMP document control software invariably reduces the time it takes in routing the document across to respective reviewers. If any manager is unavailable, the document is escalated to the next reviewer. This eliminates unnecessary delays and reduces the document review lifecycle. Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task.
Many times, departments can have dependencies with other departments for concluding some of their operations. For example, the HR department may rely on the Customer Services Department to fill out satisfaction survey forms. This dependability can give raise to departments working together in cooperation. In a GMP document control system, form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be integrated with document-based processes under one secure repository. A department can keep the look and function of existing forms or create entirely new forms suited for particular purposes.
For more information about GMP document Control, please feel free to contact a MasterControl representative.