Statistical Process Control (SPC) Software System

Software System to Automate SPC Statistical Process Control for ISO and FDA-regulated Manufacturers and Medical Device Companies - Comply with ISO and CGMP Requirements

General manufacturers, including many that conform to ISO quality standards, utilize statistical process control as a method for controlling quality. SPC, which originated in the 1920s, uses statistical tools such as mean, variance, and charts to determine whether the process being evaluated is under control.

In the FDA environment, the use of SPC is considered a good practice. For example, the FDA's final guidance on ?Quality Systems Approach to Pharmaceutical CGMP Regulations? states that quality trends should be continuously identified and evaluated, and one way of accomplishing this is through the use of SPC.

Under the FDA's ?Guide to Inspection of Quality Systems,? which is used by agency investigators to assess a medical device manufacturer's compliance with the Quality System Regulation, the importance of SPC is noted in a section about corrective/preventive action. Specifically, investigators are advised to determine if a firm uses SPC for process controls where applicable.

MasterControl Forms™ Software for Automating Statistical Process Control SPC

Many of our ISO and FDA-regulated customers rely on MasterControl Forms™ to automate the process of collecting and controlling data critical to compliance. MasterControl Forms offers the flexibility in terms of design, routing, and user and security roles. It provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Data captured on forms is automatically entered in an SQL database, and can be used for analysis.

MasterControl Forms' robust features make it an ideal solution for managing statistical process control SPC.

Here's how MasterControl Forms addresses some of the major challenges that companies face in establishing and maintaining forms-based processes.

Forms Automation Challenges		MasterControl Forms™ Software Solution
Inefficient Paper Forms System A paper-based forms process can be plagued with inefficiency and such issues as: filling out the wrong form, not completing the right form, and sending the form to the wrong person.		Cost-Effective eAutomation System MasterControl Forms automates any forms-based process and offers best-practice features that prompt users with selected data. It automates routing, notification, escalation, and approval for faster turnaround. MasterControl is Web-based, so employees, customers, and suppliers can participate in forms-based processes (i.e., data input and verification) from virtually anywhere.
Poor Data Capture Forms are designed to gather accurate and complete information critical in compliance. With paper forms, the onus lies with the operator to input accurate and complete information, and then for an analyst to accurately transfer this information to a spreadsheet or other analysis tool.		Accurate Data Capture In creating new forms or improving existing ones, companies can use a variety of field formats for accurate and accelerated data collection. With a click of a mouse, a user can select common responses keyed in the form fields that allow a list of data options previously entered. This helps ensure data is entered correctly into the form. Fields can also be set up to calculate data using simple or complex math operations.
Disconnected Processes Manual systems don't connect forms-based processes (audit findings, corrective action, etc.), making continuous improvement almost impossible. For example, if the customer complaint process is not linked to the corrective action process, a critical complaint may languish indefinitely before it can be acted upon and remediation is initiated.		Connected Processes MasterControl integrates different quality processes for a more effective and efficient quality management. For example, a change submission form can be launched directly from a CAPA form, connecting one process to the next. Relevant information will be automatically entered into the new form, reducing data entry and avoiding mistakes common in manual transfer of information.

Features

Here are some of MasterControl Forms' powerful features:

Efficient Forms: MasterControl automates any forms-based process, including routing, notification, escalation, and approval.

• Routes can be created based on a company's unique needs. For example, forms can be routed for data entry/data collection and approval. MasterControl incorporates escalation of overdue tasks. System administrators can easily create a variety of individually tailored user and security roles.

• MasterControl Forms is Web-based so employees, customers, vendors, and others involved in forms-based processes can perform their tasks from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of forms by all authorized users.

• MasterControl tracks forms by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of documents can also be reviewed using the history feature.

• Completed forms are indexed and stored, so users can search on the contents of the form.

• Forms can be signed and approved electronically. Signature manifestation ? name, date, time, and meaning of electronic signature ? can be appended automatically to each document. MasterControl's electronic signature features comply with the FDA's 21 CFR Part 11 requirements.

Flexible Form Design: Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so end users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.

Offline Forms : Off-site and traveling users or external parties (customers, vendors) can complete forms and stay in the loop even without being connected to the MasterControl system. They can complete forms offline and then upload.

Form-to-Form Launching : A form can be launched directly from another form, connecting one process 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 that process.

Document Approval via Forms : Some forms-based processes are so tightly connected with the document approval process, requiring the same signatures for both. With this feature, the process is streamlined. A form and the documents linked to it can be approved all at once, avoiding repetitive steps.

Conditional Routing: Quality-related tasks can be routed to different users depending on data entered into the form. For example, a complaint can be routed to the appropriate product team by selecting the product from a drop-down field.

Supervisor Route: Many forms-based processes require approval by a supervisor no matter who initiates the process. With MasterControl, you can add the "supervisor" to forms routes. It can also be added in succession, so the route will move from a supervisor to that person's supervisor, and so on, along the hierarchy.

Analytics and Reporting: Data captured on forms is automatically entered in a SQL database. Companies can use built-in tools to filter the data, and then chart results for instant analysis. MasterControl's advanced analytics and reporting capability provides standard and customized reports to help increase management oversight.