A Revolution InQuality System Process ManagementCompanies whose products are regulated by the FDA, especially pharmaceutic...
Business Intelligence Solutions                                                                                          Q...
The Quality System HabitFor some companies one of the most difficult habits to dispense with is the manner in which qualit...
In addition, a quality system that provides analytical and reporting features makes deviations and non-conformance datafar...
Business Intelligence SolutionsProfessional and Technical ServicesWe specialize in providing a full scope of regulatory pr...
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A revolution in quality system process management

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A revolution in quality system process management

  1. 1. A Revolution InQuality System Process ManagementCompanies whose products are regulated by the FDA, especially pharmaceutical and medicaldevice companies, stand to increase their workable ROI by millions of dollars with quality systemtechnology that accelerates innovation and streamlines compliance. | Business Intelligence Solutions | T: (800) 782-0580 | www.busintellsol.com |
  2. 2. Business Intelligence Solutions Quality Management Systems for FDA Regulated Industries www.busintellsol.com Phone: 800 782 0580 Jon Nugent Life Science Practice Manager jnugent@busintellsol.com A Revolution in Quality System Process ManagementExecutive Summary:A Revolution in Quality System Process ManagementCompanies whose products are regulated by the FDA, especially pharmaceutical and medical device companies, stand toincrease their workable ROI by millions of dollars with quality system technology that accelerates innovation andstreamlines compliance.In an age when companies stand to make millions or billions of dollars each year, making products that are safe andeffective is a matter of "Do-or-Die" business. Luckily many compliance and quality driven processes are now matters ofcourse within regulated life science environments.Executives whose products must meet regulatory and ISO guidelines know how to produce and they know how to controltheir output. Companies simply know what works and they stick to it. FDA regulated industries are subject to the factthat habits---when left unchanged---have a nasty way of turning the tables on good fortune.The good news is that new habits once implemented often maintain the balance that everyone---and every business(including life science companies)---want to maintain. | Business Intelligence Solutions | T: (800) 782-0580 | email: info@busintellsol.com |
  3. 3. The Quality System HabitFor some companies one of the most difficult habits to dispense with is the manner in which quality systems arecontrolled. Quality systems (i.e., document control, deviations control, non-conformance, equipment calibration,equipment maintenance orders, audit, CAPA, change control, training and the overall functions and philosophy thatcontrol product outputs) are often controlled manually or with a hybrid system.Quality system documentation, for example, though it is the lifeblood of a quality system and is required by mostregulatory organizations (FDA, ISO, CLIA, etc.), is often routed, viewed, approved and archived using paper-based orhybrid systems. These manual or hybrid processes greatly slow the pace of a product to market and literally cost manylife science companies hundreds of thousands or even millions of dollars for every day a product is delayed.In addition, employees who undertake these manual processes are also being paid for tedious tasks when their time couldbe put to better use.The Technology HabitTake a look at enterprise history. Those companies that implement the right technology at the right time are thosecompanies that effectively streamline and catalyze their processes and their ROI. Life science companies need to make ahabit of looking for new technology habits, especially for those technologies that are subject to continual development.For companies whose products are regulated by the FDA, the time is especially ripe for new quality systemtechnological solutions.Many pharmaceutical and medical device companies are performing better than ever. Business is booming, opportunityhas blossomed and companies have the funds they need to invest in solutions that can help them greatly speed theproduct-to-market process.Even if a product goes to market only three months earlier than it would have with manual process management,companies still stand to gain, with the help of automated quality system solutions, around a million dollars a day forevery business day during those three months. | Business Intelligence Solutions | T: 800 782 0580 | www.busintellsol.com |
  4. 4. In addition, a quality system that provides analytical and reporting features makes deviations and non-conformance datafar easier to analyze, and with streamlined connections deviations and non-conformance data can be configured to triggerresults from CAPA, change control or training solutions.Furthermore, quality system solutions that make communication simpler, such as web-based solutions that allow forcollaboration, are especially valuable as are solutions that provide audit trails for documentation and all quality systemrelated processes.The call is out for pharmaceutical, medical device and other companies that need to meet FDA regulations and ISOrequirements to consider the new habits that quality system technology can present.SharePoint services and solutions are the revolution in Quality System Process Management and have reduced the totalcost of ownership by 60% when you factor in purchased software, maintenance, training and the cost of hardware.Designed for Widespread User AdoptionThe Microsoft SharePoint offering has been designed with ease-of-use in mind, based on tools and a user interface thatyou are familiar with and that does not require a lot of training. By basing solutions on the Windows SharePoint Servicesenvironment, you have a recognizable, browser-based interface that is the same, irrespective of the type of content withwhich users can achieve the following: 1. Better Compliance: Achieve closed loop, compliant change control that tracks the results of personal training, internal quality audits and overall quality system. 2. Increase Innovation: By improving the ability to capture and share lessons learned across the company, improvements are continually built into processes, resulting in more time to focus on innovations instead of fixes. 3. Collaboration: By providing simultaneous access, people can collaborate across distances, time zones and even companies.The SharePoint Quality System Process Management solution consists of a set of common services—includingworkflow, metadata, policies, library services, security, collaboration, and search—that is available through SharePointcomponents. Similarly, functionality such as check-in/check-out, versioning, retention and auditing policies, and searchare all available in a consistent manner whether the organization is implementing a document management, a recordsmanagement, or a forms management solution.This approach requires less training of users as new components are deployed, and any extensions added by anorganization (such as new workflows, policy templates, or search interfaces) can be reused. Today, there are largecompanies who have already validated SharePoint on their own.Contact us for the recently published case studies about Roche Diagnostics, where they used SharePoint for all validatedIT documentation and the Case Study on Affymetrix.Pfizer implemented SharePoint and so has GlaxoSmithKline which announced that they are rolling out SharePointOnline to over 100,000 users. BMS is running their public Web Site on SharePoint. The U.S. Air Force operates what isprobably the largest Extranet in the world with over 750,000 users – built on SharePoint. | Business Intelligence Solutions | T: 800 782 0580 | www.busintellsol.com |
  5. 5. Business Intelligence SolutionsProfessional and Technical ServicesWe specialize in providing a full scope of regulatory products and professional services to medical device,pharmaceutical and biotechnology companies. Our expertise is in designing, integrating, supporting and validatingregulatory processes and critical software applications.Quality System SolutionsFDA Consultants will immediately supplement your organization to provide quality system solutions, which will complywith FDA and the appropriate International Regulatory Authorities regulations and standards.Compliance SolutionsAudits - Our Consultants are recognized as expert third-party auditors. We provide the correct balance and perspectiveby providing both industry experts and former FDA Investigators to perform audits.Regulatory Affairs SolutionsFDA Consultants will immediately supplement your organization to provide various regulatory solutions, includingvarious product dossiers and submissions for review and approval by the authorities such as FDA and InternationalRegulatory Authorities.Training SolutionsFDA Consultants provides both on-site and webinar, customized personnel and management training for the FDAregulated industry both in the United States and abroad.Business Intelligence Solutions offers very practical steps on how to implement some of the sweeping changes in themindset of Compliance and Regulatory executives, in bite-sized steps. | Business Intelligence Solutions | T: 800 782 0580 | www.busintellsol.com |

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