Electronic Regulatory Submissions Software Systems

The MasterControl's electronic regulatory submissions software is an integrated quality management suite which is also configurable and easy-to-use software solution that helps pharmaceutical companies attain and sustain GMP compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11) is a necessary component in FDA compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

How can MasterControl Electronic Regulatory Submissions Systems Benefit You?

MasterControl's electronic regulatory submissions system is designed to help pharmaceutical manufacturers automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project. Here's how MasterControl can ease some of the major challenges in change control.

Features of Electronic Regulatory Submission Systems

Change control is a complex process, but MasterControl's robust solution can help pharmaceutical manufacturers standardize and simplify change control procedures and electronic regulatory submissions system in order to increase efficiency and effectiveness. MasterControl Change Control includes:

Best-Practice Form – A pre-configured, multi-page form helps collect and track data every step of the way in the change control process: submission, evaluation, approval/rejection, implementation, verification, and close of project.

• A section in the change submission form captures such information as: description of change, justification, and impact. Both original and revised documents can be attached for easy comparison.
• An initiator can use one form in the electronic regulatory submissions software for multiple changes, depending on how many documents/items are affected by a change. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
• The initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements, prompting risk assessment. It also asks for classification of the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.
• The ability to prioritize is incorporated within the electronic regulatory submissions system because the form asks the initiator to categorize the change submission as routine or temporary or emergency.
• Additional forms can be customized based on the company's special needs.

Form-to-Form Launching – A change submission form can be launched directly from a Corrective/Preventive Action (CAPA) form, connecting one electronic regulatory submissions system to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered the change. Relevant information from the CAPA form will be automatically entered into the change submission form, reducing data entry. It also shows the history of the entire process.

Document Approval via Forms – The change submission form and the documents linked to it can be approved all at once, avoiding repetitive steps.

Dependent Routing – Completion of a task can be made from the electronic regulatory submissions software dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates the relationships between dependent processes.

Dynamic Explorers – MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use and dynamic tool for easy search and retrieval of documents. All SOPs and other documents related to a particular change can be grouped together. Users can create virtual folders within Explorers that will automatically retrieve documents based on pre-defined queries for effective electronic regulatory submissions system.

Powerful Reporting Tool – Data can be grouped together by a date interval and then charted over a date range. For example, the number of customer complaints that have led to a change can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc.

Sustained Compliance – Inadequate change control can lead to serious quality system violations and expose pharmaceutical manufacturing companies to product liability actions. The MasterControl electronic regulatory submissions software is designed not only to help you attain FDA and ISO compliance – but to sustain it year after year – by interconnecting all quality subsystems, strengthening the change control procedure, fostering efficiency throughout the enterprise, and keeping compliance costs down. MasterControl offers comprehensive validation services, including protocols and consulting services. More importantly, MasterControl offers you something beyond software: a partnership that will support your compliance efforts in the long term.

For More Information about Electronic Regulatory Submissions Software Systems

For more information on how MasterControl's electronic regulatory submissions software systems can help your pharmaceutical company with its eSubmissions, please feel free to contact a MasterControl representative.