Both FDA regulations and ISO quality standards require manufacturers to establish a document control system to ensure product quality and safety and MasterControl's document revision version control program helps in achieving those requirements. Maintaining proper version and revision control is essential. This is one reason companies want to bring conformity in the way they carry out manufacturing operations. By incorporating MasterControl’s document revision version control program, you can be assured of keeping every single personnel enacting SOPs on the same page.
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A document revision version control program helps ensure that production processes and methods are all pre-approved and that any change in these processes are restricted to authorized personnel and tracked for future review. Despite the underlying importance of document management and control, many companies continue to rely on paper-based and partially electronic document management systems that are plagued by inefficiency and version control errors that could cause FDA-483 citations or ISO nonconformance.
Converting a paper-based document control process to an electronic process may be challenging, but it ultimately helps eliminate common errors that could lead to serious regulatory problems.
MasterControl Documents, an integrated part of the MasterControl quality management suite, helps companies automate their electronic document management processes by providing centralized and secure access to all documentation through the Internet. Here are some of the features and benefits of implementing an electronic document management software solution:
Be it a small, medium or large-sized company, there is no denying the fact that the need of maintaining documentation is prevalent. Paper-based or hybrid systems may help companies to manage documentation including SOPs, company policies, reports, etc, but in the long-run, it is difficult to manage documentation. Most companies are unable to easily keep track of all documents residing in the business. To search for a document in the company archives becomes problematic during an audit.
MasterControl's document revision control program 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. This removes immense weight off of the managers who are provided with the leverage to create documents of any kind and store these in the centralized repository which recognizes the documents irrespective of their format.
MasterControl’s document version control program is built on the principle of simplicity. It is designed to enable users to conduct easy searches through the standardized "Google-like" search window that is available throughout the application, which means all authorized users can search for tasks, training records, policies, and other documents using a familiar search interface. Similarly, documents are easy to find. The quick retrieval of documents ensures that the users are able to continue their tasks without any halt. Every department in the company can enhance their productivity through the concept of Explorers. Every department can maintain its own Explorers and documents can be stored in multiple Explorers.
Many companies are based in multiple locations which implies that all employees require access to SOPs to perform their assigned duties. With the companies constantly evolving the way they perform operations, the risk of producing a product batch with an out-dated version of an SOP is always present. There must be a mechanism to ensure that only the current or updated version of an SOP is readily available for users to access. MasterControl provides automatic document revision control to ensure that only the current version of a standard operating procedure SOP is available. In case an SOP is being updated, only the current, approved version can access by other users through the portal. This locking of the document helps in preventing employees from enacting on out-of-date or in progress SOPs.
MasterControl’s revision control program helps in giving managers the background of why a change is made in the first place. When the user makes a change, the program prompts to enter the reason for the change.
MasterControl's document revision version control program tracks documents by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of electronic documents can also be reviewed using the history feature.
With MasterControl's document revision version control program, electronic documents can be signed and approved in an automated fashion. The program helps in providing a complete background of exactly when a change was made to the document. Electronic signature manifestation, name, date, time, and meaning of electronic signature, can be appended automatically to each document.
One of the major concerns of any organization is the time it takes to sign and approve documents. Excessive delay in approval can cause unnecessary delay in manufacturing products correctly with the updated SOPs. As companies don’t want to stop production, the out-of-date methods are still used in manufacturing. This brings inefficiency and potential loss of capital. MasterControl’s document revision version control program helps in reducing document cycle time by automating routing and approval and incorporating escalation for overdue tasks. The primary objective is to help in approving documents and checking them in the centralized repository for employees to continue work without any halt or stoppage in the operations. If a document approval remains pending because of the unavailability of some manager, the document is routed to the next reviewer. This ensures that the documents are approved at the earliest possibility. 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 companies wish to attain FDA & ISO compliance. Any instance of non-conformity must be eliminated. This helps the companies to standardize the procedures and attain ISO compliance such as ISO 9000, 9001 and 14000. Most of the ISO regulations demand for a document control system that is proficient in maintaining updated and secure documentation of all SOPs. Documentation of any company consists of sensitive data that cannot be comprised. For this reason, the document revision control program provides with the 21 CFR Part 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies. With MasterControl's document revision version control program, an electronic document is stored in virtual vaults located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is compromised.
MasterControl’s document revision version control program provides a secure, time-stamped audit trail exceeding 21 CFR part 11 requirements. MasterControl documents identify the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
All companies are interested in finding various statistics and parameters of its business. It is of extreme importance to generate timely reports that give out the true picture of the company’s business. This helps in devising strategies for increasing productivity and revenue for the organization. MasterControl's document revision control program uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight.
To learn more about document revision version control program; please feel free to contact a MasterControl representative.