MasterControl Blood and Biologics Express Suite™

Sotware System for Automating Business Processes for Blood and Tissue Companies

MasterControl Inc. offers a complete solution that allows blood and biologics organizations to affordably resolve typical quality management, compliance, document management, change control, and collaboration pains. This hosted solution is specifically designed to meet the compliance needs of blood, tissue, and eye banks as well as organ procurement organizations.

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	Product Data Sheet: MasterControl Blood and Biologics Express Suite™
	White Paper: Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid
	White Paper: Software Automation in the Blood and Biologics Industry
	Case Study: ARUP Laboratories
	Case Study: Iowa Blood

Who Can Benefit from MasterControl's Blood and Biologics Express Suite?

Here's how MasterControl can help blood and biologics companies streamline their processes and enhance efficiency:

Challenges		MasterControl Blood and Biologics Software Solution

Disconnected Manual Systems: Documents on manual approval routes are difficult to track down and take too long to approve. SOPs must be continually redistributed. Confusion reigns when documents are handled in team efforts. Manuals may be dispersed among multiple departments and/or locations and can be difficult to update as documents change. Quality personnel have difficulty staying current and making sure that audit information is accessible.		Simplified Process and Document Management: MasterControl connects business processes and provides vastly increased control over documents and training. Document approval routes are automated and easy to track, which accelerates approval processes and ensures that employees have the latest version of a document. At the click of the mouse users can tell who has approved or who is sitting on a document. Documentation can be instantly accessed in MasterControl's secure, centralized repository, making it quick and easy for employees to access SOPs, policies, and work instructions.

Inefficient Quality Management: When document control, training, and CAPA systems are disconnected, the organization is consistently prone to wasting money, manpower, and time. Management becomes a bottleneck when supervisors are required to manually assign, track, and update training tasks. These manual processes keep track of individual elements of the quality system, but do not provide the "Big Picture."		Automated Quality Management System: The MasterControl QMS focuses on utilizing document control to connect departments and processes, thereby increasing internal visibility, eliminating redundancies, reducing waste, and promoting collaboration throughout the organization. The system is ready to work out of the box and is specifically preconfigured for blood, tissue, and eye banks as well as organ procurement organizations.

Inefficient CAPA Systems:: Non-compliant CAPA systems are the number one cause of the issuance of an FDA-483 form. With no straightforward link between CAPAs and updated documents, personnel are out of touch and frequently overburdened by small-issue CAPAs that must be investigated and resolved. Forms can be difficult to track and report on.		Connected CAPA System: MasterControl's CAPA system supports root cause analysis to find a true corrective action. CAPAs are more than just simple data management systems -- MasterControl transforms them into robust learning systems that actually improve business processes.

MasterControl Blood and Biologics Express Suite - Features and Benefits

Greater Control: Documents, collaborations, processes, and forms are originated, tracked, and dispositioned in MasterControl's controlled environment, which promotes better communication organization-wide and improves the ability to solve problems quickly.

Unparalleled Services: MasterControl's experts can get the solution up-and-running quickly in order to maximize time and resource savings. Regardless of existing in-house capabilities, MasterControl Inc. can provide any organization with a comprehensive solution backed with superlative services. Whether the organization simply needs training on MasterControl's functionality or requires assistance configuring the system to specific needs, the MasterControl system can be packaged with any level of service and support the organization requires. An organization lacking knowledge of particular requirements that must be addressed can have MasterControl's expert advisory team analyze the circumstances and develop and clearly map out those requirements.

Additional Services beyond the Solution: MasterControl experts can do anything a client needs to reach required objectives. MasterControl can even serve as an organization's training department -- whether it is individual training for new employees or educating an entire department on new processes that have been implemented, MasterControl has a solution. Trainees can learn via recordings or in a classroom environment with a live instructor. MasterControl is also renowned for having industry experts readily available for clients. Preparing for an audit? Struggling with validation? Pitching a big client? Looking for better vendors? Whatever it is, MasterControl's experts have seen it before. Whether it's a long-term consulting relationship or a short-term project that requires management, MasterControl can help.

Rapid Deployment: MasterControl's Blood and Biologics Express Suite is preconfigured specifically for this industry, reducing the amount of time and effort it takes to set up the system.

Easy Validation: The implementation includes MasterControl's proven Transfer OQ™ methodology. With Transfer OQ, MasterControl can accelerate the validation process while reducing the stress on the customer. The Transfer OQ tests all MasterControl functionality and provides the entire validation in a set of binders. All that is left for the customer to do is the PQ.

Affordable System: By offering a hosted system, MasterControl reduces costs since no hardware investment is required. MasterControl allows clients to have all the benefits of an electronic system with low overhead cost.

Training Transparency: MasterControl Training™ automates required training courses and tracks each individual task, which gives training managers real-time transparency into the status of every employee's training records. Training courses and associated documents can be automatically triggered based on dates, revisions, or other customized rules. MasterControl Training also ensures competency for all completed training tasks.

Up-to-date Assurance: The MasterControl system can be set to make sure that documents are reviewed within a pre-determined time frame to ensure contracts are appropriately updated.

Effective MSDS Management Processes: Using MasterControl Documents™, Material Safety Data Sheets (MSDSs) can be controlled and accessed exactly the same as any other document, easing the burden to keep the company current on safety hazards.

Robust Reporting and Tracking: Custom-defined metrics and specifications can be trended and reports can be automatically generated and distributed to appropriate staff.

Eased Regulatory Burdens: With MasterControl, regulatory compliance is simply a part of your workflow, not a burden to it.

Improved Organization: MasterControl utilizes virtual folders and taxonomies to ensure that users are only working with the most recent revisions.

Reduced Mistakes: Regardless how rapidly iterations of documents, forms, or work instructions are produced, the electronic MasterControl system keeps pace and ensures that documentation is always up to date, users have easy access to the most recent releases, and employee training is kept current, all of which minimizes rework and scrapped product.

Advantages of MasterControl

MasterControl's advanced document control functionality is more conducive to streamlining processes throughout the organization. Users from any department can collaborate on the same document with ease. The system provides a transparent overview of document control, training, and CAPA, which helps ensure that management decisions are based on accurate data. By minimizing bottlenecks and inefficiencies across multiple departments, MasterControl reduces the amount of effort and total time required to ensure quality and regulatory compliance.