Mastercontrol introduces Version 8.0 software

Jonathan Beckstrand, Mastercontrol's chief executive officer, said: 'The enhanced Mastercontrol solutions can help companies get their products to market faster, reduce overall costs and increase internal efficiency.' Mastercontrol Version 8.0 features Mastercontrol Supplier, which gives companies the capability to efficiently manage and approve vendor lists and effectively track supplier quality and supplier status.

With Mastercontrol Supplier, all supplier status and quality information (such as non-conforming material reports) is automatically contained in a single, easy-to-access location, according to the company.

Goods or services can be added to the 'approved-to-supply' list by linking the goods or services to a specific supplier within Mastercontrol.

Suppliers can be added in the same way.

If a part is linked to a supplier that is not approved, the link is disabled until the supplier becomes approved or re-approved.

All of this information is obtainable via Mastercontrol's built-in reporting tool.

Users of Mastercontrol Supplier have a variety of functionality options, such as creating suppliers in the system, viewing lists of suppliers, searching for suppliers and importing supplier information.

All goods and services and supplier links operate bi-directionally within Mastercontrol Virtual folders and analytics reports can be embedded in the Mastercontrol Supplier tab, converting the supplier 'infocard' into a dashboard.

Furthermore, users are able to configure the templates to choose from based on the type of supplier being added.

Mastercontrol QMS corrective/preventive action (CAPA) solutions are three distinct holistic software solutions designed to automate and manage the CAPA process and integrate it with other quality processes, such as change control, audit, training, non-conformance resolution and customer complaints.

The Mastercontrol QMS CAPA system guides users through the CAPA process with the assistance of embedded decision mechanisms.

The product includes a CAPA methodology and comes complete with best-practice training, services and consulting.

Mastercontrol QMS CAPA solutions lead companies to faster resolutions by offering guiding mechanisms that result in more effective decision points, according to the company.

With the Mastercontrol MS Word integration, the Mastercontrol document management solution can be accessed via a Mastercontrol add-on toolbar in MS Word 2007.

The integration allows users to search, access, review and collaborate on critical documents within MS Word.

The seamless integration between Mastercontrol and MS Word merges two applications into one, which is said to streamline processes that allow users to avoid extra steps while ensuring the proper control over critical documents.

The Mastercontrol Outlook email integration allows everyday and infrequent users alike to access Mastercontrol tasks from any HTML email client, including Microsoft Outlook.

The interface facilitates improved efficiency by providing quick connections via a familiar tool used by all employees everyday, according to Mastercontrol.

As a benefit of the integration, is it claimed that executives and managers can efficiently complete critical approvals using just their email.

It is also said that users can perform everyday tasks in a familiar interface, without needing an extensive knowledge of Mastercontrol.

Mastercontrol offers a seamless, out-of-the-box integration with Sharepoint that capitalises on the benefits of Sharepoint while adding compliance solutions.

Rather than forcing users to access disparate solutions, Mastercontrol connects the two systems so that processes may be fulfilled within the same platform of customisable, unified solutions.

Without leaving Sharepoint, users are able to log into Mastercontrol and locate important documents or export a document from Sharepoint into Mastercontrol.

The Sharepoint Connector also ensures that users are working with the most current version of a document.

The most recent versions of documents are stored in Mastercontrol's secure, centralised repository.

Links to these documents are added to the Sharepoint library, simplifying access for the user.

Users can continue to use the Sharepoint interface and enhance its capabilities by adding document control and other Mastercontrol business-process functionalities.

MasterControl Data - an extension of the Mastercontrol Process platform - is a set of tools that allows administrators to create customised data repositories.

The records stored in these repositories can be viewed and maintained by end users within the Mastercontrol system and can be linked to electronic forms, thus enabling complex process modelling and facilitating data entry.

Customer, supplier and business-partner information can be stored and linked to complaints, audits and supplier deviations.

Equipment master lists can be maintained from within Mastercontrol and linked to calibration work orders, maintenance work orders and batch records.

Mastercontrol Classes is an add-on to the Mastercontrol training solution that helps customers to manage classes.

For example, users are able to schedule training resources - trainers, locations and trainees - by creating classes.

Administrators can specify the number of slots for various training classes and allow trainees to sign up for them.

This helps customers to manage fixed classroom resources, such as the number of trainees that can be taught in a common training room.

Mastercontrol taxonomy organisers allows each group within the enterprise to have its own taxonomy with the capability to have a single document existing in one or more taxonomies.

SOPs, drawings, contracts, clinical documents or any type of submission documentation can be automatically categorised and updated by the Mastercontrol system.

According to the company, taxonomy organisers feature an interface similar to Windows Explorer with a folder structure defined by Mastercontrol 'infocards' and custom metadata.

Furthermore, multiple folder structures allow individuals or groups of users to view information in the way that makes the most sense to them.

Documents are automatically updated in one or more hierarchies as soon as the documents are entered into Mastercontrol.

Mastercontrol Version 8.0 also brings many enhancements and expanded functionality to existing Mastercontrol solutions, such as the Mastercontrol Portal.

Mastercontrol 8.0 features a streamlined user interface, including module landing pages, homepage quick links and the ability for users to change skins and themes.

The system now features support for the Mozilla Firefox web browser.

Additionally, pages in the Mastercontrol system are resized in line with the browser, meaning that more content can be viewed with higher-resolution settings and larger monitors.

Users can directly sign off on straightforward tasks directly from their HTML email client, without needing to access the Mastercontrol web-based user interface.

Roles have owners, limiting the visibility of role assignment, and users can grant rights only for the roles that they have, which is intended to enable greater control over distribution administration.

End users can request new passwords once they successfully answer security questions; this is intended to make it easier to manage password resets.

Other improvements include shorter, user-set expiration times, out-of-office notifications upon login, vault creation from the login page, a link to 'infocards' from the publishing queue, filtering by nulls in queries, a mandatory sign-off meaning option, 'infocard' searching from tracking, longer route step names and file-size display.

MS Word 2007 users can connect to Mastercontrol directly from Word to access documents located in their open collaborations, search for documents, check documents in and out and start new collaborations.

Complex change-control processes can be streamlined now that Mastercontrol Documents offers the capability to create multiple packet types in conjunction with a new route step type.

The packet types can be configured both with custom and pre-configured fields to capture data about the change control, such as work in process and disposition.

The system indicates from the list page and the 'infocard' if a later revision of the 'infocard' exists.

This is claimed to help the user, who may not have access to the draft vault, be aware that an update is in process.

A novel organiser allows the user to determine desired hierarchies - which are automatically maintained without further administrative intervention - based on metadata fields.

In addition, users can right-click on the 'infocard' to perform various actions, such as checking out documents or viewing native documents or PDFs.

In addition to PDF forms, the Process module supports HTML forms.

The form designer can choose which technology is most appropriate on a process-by-process basis.

HTML forms can reuse the same keywords, workflows and reports that already exist in the system.

Process designers now have the capability to manage lists of data within the system by creating datasets that are managed outside of a form.

These datasets can be simple lists or data tables to capture more complex entities, such as pieces of equipment.

Users with appropriate rights can launch retraining tasks directly from a form.

For example, if the result of a CAPA investigation determines that trainees should be retrained, this can be invoked for the affected trainees directly from the CAPA form.

Users who launch a form can now abort it if no one has completed any data.

Additionally, process routes can now be defined by detailed reports.

After editing them in the workspace, recent tasks can be highlighted so that a user does not lose his or her place when working on large projects.

Mastercontrol Projects offers the capability to modify route users and abort in-process tasks.

A new right enables users to launch retraining tasks for those they do not directly supervise.

Additional fields can be added to the BOM workspace that will appear in both the workspace and part detail pages.

Mastercontrol is claimed to be able to export BOMs to MS Excel spreadsheets and has the ability to export BOMs for use in third-party software, such as enterprise resource planning (ERP) systems.

The enhanced system also offers the capability to upload multiple BOMs from a single import spreadsheet.

Attributes defined with Pro/Intralink or PDMWorks may be mapped to existing fields in PDM systems.

They may also be mapped to specific 'infocard' fields within Mastercontrol, including custom fields, allowing users to leverage existing metadata in their PDM system.

Users can now also import multiple configurations from PDMWorks.

The system automatically creates a separate 'infocard' in Mastercontrol for each configuration in Solidworks files.

Many drop-down fields can be configured for one of multiple options: static drop-down options; external data sources; or a data structure stored in Mastercontrol.

This change no longer requires customisation; for example, a 'product' field on a form can display the products stored in the ERP system and the equipment calibration form directly links to the equipment master list stored in Mastercontrol.

During installation, templates require much less manual configuration because field properties are automatically detected.

Roles associated with solution packages are now prefaced with 'SP_', which is intended to improve navigation on the roles list page.

The Complaints HTML solution features reportable event decision trees, enhanced alignment with CAPA and integration with the customer's complaint database.

Mastercontrol's CAPA HTML solution utilises the Pathwise methodology for the investigation and recording of CAPA.

It offers refined root-cause investigation, detailed task tracking, formalised verification and validation for CAPA implementation and more flexible forms with expanding fields, according to Mastercontrol.

The CAPA HTML solution also features layers with filtering, allowing for an initial review to take place prior to deciding whether or not an event should go to CAPA.

Process reports are now based on datasets that administrators can configure for each template.

The company claims that changes to data storage and retrieval have enhanced process report performance.

By joining datasets together to create dataset profiles, users can display data from multiple process templates on the same report.

Users have the option to filter text fields using an 'Is Null' or 'Is Not Null' operator.

The custom field report includes all the main 'infocard' fields so that they can be reported on and filtered against.

Additionally, datasets can be created for a custom field, allowing the custom field report to filter specific custom field data.

Users are able to rename the system-generated aggregate data columns in a report to provide more meaningful, customised names.

The network printers can be configured and filtered by business unit in enterprise configurations.

The company claims that the Mastercontrol integrated compliance software solution suite is designed to enable companies to meet and exceed FDA requirements, ISO standards and similar regulatory requirements.

The software facilitates compliance management by automating and managing document control, change control, training management, audits, CAPA, customer complaints, non-conformance disposition, deviation handling, electronic batch record (EBR) management and other GxP processes critical to regulatory compliance.