eProcess Automation Software - Features & Benefits - MasterControl Process™
Software for Automating Business Procsses to Improve Efficiency and Save Money
Many companies use paper forms to gather, secure, and process information. Some of this information may pertain
to commonplace business processes, others may be critical to regulatory compliance. In manufacturing environments, forms are heavily used to perform such data-capture activities as audits, corrective/preventive actions, nonconformances, deviations, customer complaints, etc. Whatever the purpose,
MasterControl Process™ converts paper-based processes to electronic ones, unlocking the power of electronic tracking,
concurrent routing, and instant access to all records.
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 addresses some of the major challenges that companies face in managing their business
and quality 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.
|
|
Disconnected Processes
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.
|
|
Connected Processes
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.
|
|
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 of
current 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 MasterControl
or third-party databases eliminating duplicate repositories.
Web-Based Platform: MasterControl is Web-based and connects all employees and other authorized users
regardless 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 successful
implementation and validation.
Flexible Platform: Process designers can choose from two design platforms. PDF 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.
|
How MasterControl Makes Your Job Easier
