1. A Revolution In
Quality System Process Management
Companies whose products are regulated by the FDA, especially pharmaceutical and medical
device companies, stand to increase their workable ROI by millions of dollars with quality system
technology that accelerates innovation and streamlines compliance.
| Business Intelligence Solutions | T: (800) 782-0580 | www.busintellsol.com |

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 Management
Executive Summary:
A Revolution in Quality System Process Management
Companies whose products are regulated by the FDA, especially pharmaceutical and medical device companies, stand to
increase their workable ROI by millions of dollars with quality system technology that accelerates innovation and
streamlines compliance.
In an age when companies stand to make millions or billions of dollars each year, making products that are safe and
effective is a matter of "Do-or-Die" business. Luckily many compliance and quality driven processes are now matters of
course within regulated life science environments.
Executives whose products must meet regulatory and ISO guidelines know how to produce and they know how to control
their output. Companies simply know what works and they stick to it. FDA regulated industries are subject to the fact
that 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. The Quality System Habit
For some companies one of the most difficult habits to dispense with is the manner in which quality systems are
controlled. 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 that
control 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 most
regulatory organizations (FDA, ISO, CLIA, etc.), is often routed, viewed, approved and archived using paper-based or
hybrid systems. These manual or hybrid processes greatly slow the pace of a product to market and literally cost many
life 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 could
be put to better use.
The Technology Habit
Take a look at enterprise history. Those companies that implement the right technology at the right time are those
companies that effectively streamline and catalyze their processes and their ROI. Life science companies need to make a
habit 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 system
technological solutions.
Many pharmaceutical and medical device companies are performing better than ever. Business is booming, opportunity
has blossomed and companies have the funds they need to invest in solutions that can help them greatly speed the
product-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 for
every business day during those three months.
| Business Intelligence Solutions | T: 800 782 0580 | www.busintellsol.com |

4. In addition, a quality system that provides analytical and reporting features makes deviations and non-conformance data
far easier to analyze, and with streamlined connections deviations and non-conformance data can be configured to trigger
results from CAPA, change control or training solutions.
Furthermore, quality system solutions that make communication simpler, such as web-based solutions that allow for
collaboration, are especially valuable as are solutions that provide audit trails for documentation and all quality system
related processes.
The call is out for pharmaceutical, medical device and other companies that need to meet FDA regulations and ISO
requirements 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 total
cost of ownership by 60% when you factor in purchased software, maintenance, training and the cost of hardware.
Designed for Widespread User Adoption
The Microsoft SharePoint offering has been designed with ease-of-use in mind, based on tools and a user interface that
you are familiar with and that does not require a lot of training. By basing solutions on the Windows SharePoint Services
environment, you have a recognizable, browser-based interface that is the same, irrespective of the type of content with
which 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—including
workflow, metadata, policies, library services, security, collaboration, and search—that is available through SharePoint
components. Similarly, functionality such as check-in/check-out, versioning, retention and auditing policies, and search
are all available in a consistent manner whether the organization is implementing a document management, a records
management, or a forms management solution.
This approach requires less training of users as new components are deployed, and any extensions added by an
organization (such as new workflows, policy templates, or search interfaces) can be reused. Today, there are large
companies 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 validated
IT documentation and the Case Study on Affymetrix.
Pfizer implemented SharePoint and so has GlaxoSmithKline which announced that they are rolling out SharePoint
Online to over 100,000 users. BMS is running their public Web Site on SharePoint. The U.S. Air Force operates what is
probably 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. Business Intelligence Solutions
Professional and Technical Services
We 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 validating
regulatory processes and critical software applications.
Quality System Solutions
FDA Consultants will immediately supplement your organization to provide quality system solutions, which will comply
with FDA and the appropriate International Regulatory Authorities regulations and standards.
Compliance Solutions
Audits - Our Consultants are recognized as expert third-party auditors. We provide the correct balance and perspective
by providing both industry experts and former FDA Investigators to perform audits.
Regulatory Affairs Solutions
FDA Consultants will immediately supplement your organization to provide various regulatory solutions, including
various product dossiers and submissions for review and approval by the authorities such as FDA and International
Regulatory Authorities.
Training Solutions
FDA Consultants provides both on-site and webinar, customized personnel and management training for the FDA
regulated 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 the
mindset of Compliance and Regulatory executives, in bite-sized steps.
| Business Intelligence Solutions | T: 800 782 0580 | www.busintellsol.com |