For regulated manufacturers, forms whether paper or electronic (eforms), are necessary to perform data-capture activities. They are especially critical in gathering, securing, and processing information for quality processes necessary to conform to life science regulations and ISO quality standards, such as audits, nonconformance, corrective/preventive actions, and customer complaints.
To be effective, electronic forms-based processes should be flexible in meeting an organization's needs. They should be efficient in getting input and approval from everyone involved and should allow collaboration among several people or departments.
The MasterControl Process software application provides a powerful and intuitive toolset to model any process, using a graphical workflow designer. User access security, complete audit trails, and electronic signature capabilities enable compliance with the most stringent regulations and standards, such as FDA and ISO.
For the lowest cost and fastest implementation, MasterControl offers many solutions that are based on MasterControl Process. For more demanding customers, an experienced services team is on hand that can modify these according to specific requirements. Finally, our team can also create custom solutions from scratch for the best possible fit for your organization.
MasterControl also offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. These services have proven to make the validation of software upgrades easier, faster, and more cost-effective.
Here's how MasterControl Forms addresses some of the major challenges that FDA-regulated contract organizations face in establishing and maintaining forms-based processes.
Forms Automation Challenges
MasterControl Process™ 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, misplaced forms, having to send the form to one person at a time, and sending the form to the wrong person.
Efficient eAutomation System
Users' ability to launch processes is rights based, reducing the potential for mistakes. Electronic tracking indicates where any task is within a process. Configurable workflows automate routing to appropriate participants and can escalate the task if timelines are not met. Tasks can be processed concurrently by multiple users or even groups. These features taken together achieve the most efficient turnaround possible.
Poor Data Capture
With paper forms, the onus lies with the operator to input accurate and complete information on a form.
Accurate Data Capture
Companies can use a variety of field formats along with field validation for accurate and accelerated data collection. With the click of a mouse, a user can select from a number of pre-configured options. For ease of administration, these pre-configured options can be stored centrally and used across multiple processes.
Poor Data Access
In order to analyze data across multiple paper forms, an analyst must manually and accurately transfer this information to a spreadsheet or other analysis tool. This is a slow, error-prone process that is unlikely to be used widely.
Real-time Data Access
MasterControl's Analytics module contains user-configurable reports that always show the latest data at the click of a button.
In manual systems, every form is an independent entity that has to be completely and accurately filled out. The relationships between forms cannot be easily navigated, such as when a complaint triggers a CAPA, because these forms might be stored in different locations. Getting the big picture is difficult because data analysis is a tedious manual process.
MasterControl processes are connected to other related processes, controlled documents, external data repositories, and internal data structures. For example, a Change Control can be launched directly from a CAPA, connecting one process to the next and allowing for easy navigation between the two. Relevant information is automatically passed to the new process, reducing data entry and avoiding mistakes common in manual transfer of information. Product information can be pulled from an ERP system, documents can be attached to a Change Control, and Error Codes for Complaints, Deviations, OOS and other quality processes can be administered from a single internal location.
MasterControl Forms, an integrated part of the MasterControl quality management suite, automates, streamlines, and effectively manages forms-based processes to help ensure FDA and CLIA compliance.
Here are some of MasterControl Process' powerful features:
Compliant System: MasterControl helps companies attain continuous compliance by simplifying and optimizing workflows, enforcing procedures, and lowering overall compliance cost.
Automated Processes: Automation helps simplify the compliance environment by enforcing the procedures related to each process while enabling the decision making abilities of qualified personnel.
Flexibility in Workflow Design: Process designers can configure all aspects of a workflow, including the assigned users, what users can do with the task (such as rejecting or approving it), the number of approvers required to move to the next step, which pages are viewable or editable, which users are allowed to change user assignments to the step, and when the task escalates to another set of users. These features and many more ensure that virtually any process can be accommodated.
Streamlined Performer/Witness Signoff: A process step can be configured to allow two people to sign off from a single screen. This is necessary for tasks that require a witness during completion (e.g., electronic batch records) and eliminates the need for one user to log out and another to log back in so the second signature can be committed.
Concise Signature Meaning: The signature meaning can be configured for each step and is displayed in all views of the signature record: the sign-off dialog, the tracking entry, and on the signature manifest.
Analytics and Reporting: Pre-configured reports for a process are created in MasterControl's Analytics tool, allowing for advanced data analysis. These reports can include any user-entered data as well as metadata on the process task. Reports can also include pie charts, bar charts, trend charts with drill-down capabilities, and are easily modified by end users. Chart dashboards provide a quick overview ofcurrent activity and scheduled reporting assists in regular reviews of key data.
Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification. Account lockout stops unauthorized users from gaining system access.
Connected System MasterControl connects processes to each other as well as centralized data repositories in MasterControlor third-party databases eliminating duplicate repositories.
Web-Based Platform: MasterControl is Web-based and connects all employees and other authorized usersregardless of location.
Integrates with Other Applications: MasterControl integrates with applications like ERP, LIMS, accounting, and human resources applications to connect different departments and operations within an enterprise.
Offline Forms: Off-site users or external parties (customers, vendors, etc.) can complete forms, such as CAPA or a customer complaint, even without being connected to the MasterControl system. They can complete forms offline and then upload.
Process-to-Process Launching: A process can be launched directly from another process, generating a link between the two for easy navigation. The child process is automatically populated with data from the parent process minimizing manual effort and ensuring data accuracy.
Access to Centralized Data: Processes can display and let the user select data from central repositories, whether they are stored in a third party application or administered internally in what is called a "data structure." Common examples are product information from an ERP system or an Equipment Master in a MasterControl data structure. MasterControl data structures are fully configurable and can accommodate anything from a simple picklist to a fullblown table of records. If desired, data can even be changed directly from a Process.
Document Approval via Process: Some processes are tightly connected with the document approval process, requiring the same signatures for both. With this feature, a process task and the documents linked to it can be approved at once, avoiding repetitive steps.
Complete System MasterControl offers robust software, plus the appropriate tools and services necessary for successfulimplementation and validation.
Flexible Platform: Process designers can choose from two design platforms. HTML forms provide straightforward, easy to implement design tools that create document-like forms. Processes designed in HTML can take advantage of powerful application-like functionality, such as expandable fields, a layout that can be dynamically rearranged, and tabs that can arrange data in intuitive ways.
Continuous Validation: For FDA-regulated companies, MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services include MasterControl Transfer OQ™.
Product Training: MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. The team conducts training at MasterControl's state-of-the-art Education Center in Salt Lake City and also at customers' facilities.
Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.
To have a complete detailed information about MasterControl Process and eProcess automation software systems, feel free to contact MasterControl technical representative today.