Pharmaceutical & Biotechnology Process Automation Software Systems


Pharmaceutical & Biotechnology Process Automation Software Systems Helps in Automating Pharmaceutical Data Collection Processes to Comply with GMP 21 CFR Part 11 and Part 211

Most pharmaceutical companies use forms to collect data from customers, employees, vendors, and contractors instead of pharmaceutical and biotechnology process automation software. In the FDA and ISO environments, forms are heavily used to perform such data-capture activities as audits, out-of-specifications, nonconformances, deviations, corrective/preventive actions, and customer complaints.

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How can Pharmaceutical and Biotechnology Process Automation Software Benefit You?

MasterControl Process, an integrated part of the MasterControl's pharmaceutical and biotechnology process automation software, automates, streamlines, and effectively manages pharmaceutical forms-based processes throughout the organization to help ensure compliance with FDA regulations.

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

Process Automation Challenges MasterControl Process™ Software Solution
Inefficient Paper Process System

A paper-based pharmaceutical and biotechnology process automation system, process can be plagued with inefficiency and such issues as: filling out the wrong form, not completing the right form, sending the form to the wrong person, and not having the right person available when a form reaches them.

Cost-Effective eAutomation System

MasterControl Process automates any forms-based process and offers best-practice features that prompt users with selected data. Pharmaceutical and biotechnology process automation software 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 for the pharmaceutical and biotechnology process automation systems. 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 available in the MasterControl's pharmaceutical and biotechnology process automation software can also be set up to calculate data using simple or complex math operations.

Disconnected Processes

Manual pharmaceutical and biotechnology process 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's pharmaceutical and biotechnology process automation software 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 of Pharmaceutical and Biotechnology Process Automation Software

Here are some of MasterControl Process 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's pharmaceutical and biotechnology process automation software incorporates escalation of overdue tasks. System administrators can easily create a variety of individually tailored user and security roles.
  • MasterControl Process 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 within pharmaceutical and biotechnology process automation software. 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 HTML, 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's pharmaceutical and biotechnology process automation 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's pharmaceutical and biotechnology process automation software, 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.

Learn More About Pharmaceutical and Biotechnology Process Automation Software Systems

Contact MasterControl representative to learn more about the pharmaceutical and biotechnology process automation software systems.