Dec 30, 2014

Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success

Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success
Stedman Graham shared his nine-step plan for 
success at MasterControl's Masters Summit.
by Cindy Fazzi
Editor, MasterControl Insider

Stedman Graham, CEO of S. Graham and Associates and a best-selling author of motivational books, shared the secret to his success. No, it’s not Oprah, though he’s widely known for his long-time relationship with one of the world’s most famous media personalities. 

During his keynote speech at the Masters Summit, MasterControl’s premier educational conference for customers, Graham said, “When I think of MasterControl, I think of leadership.”(1) He posed a challenge to the standing-room-only crowd: “Can you be the master of your own development? Can you master your own life? Can you co-create with the world?”

Dec 23, 2014

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

FDA issued a new draft guidance in 2013 on 
the biological evaluation of medical devices.
by Cheryl Wagoner
Principal Consultant/Owner
Wagoner Consulting LLC

As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard.  The current FDA guidance regarding biological evaluation of medical devices, Blue Book Memo #G95-1, was issued July 1, 1995 and replaced the FDA Tripartite Biocompatibility Guidance #G87-1 (April 24, 1987).  On April 23, 2013, FDA issued a new draft guidance entitled “Use of the International Standard ISO-10993 BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing”.  This guidance has much in common with the current Blue Book Memo, but expands the details in a number of areas especially regarding the test matrix and the level of detail regarding each test.

Dec 18, 2014

Basics: Documenting a Real QMS

Basics: Documenting a Real QMS

Plan/Do/Check/Act (PDCA) applies to real life
processes and systems,
not to systems of documents
panderingto the requirements of ISO 9001.

by T. Dan Nelson

Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

A QMS is composed of processes impacting an organization’s ability to fulfill customer requirements.  Two types of processes  compose a QMS: core processes (or primary, realization, or operational processes) and support processes.  Core processes. in a sense, define what an organization does for a living, while support processes are in place to help assure the effective, efficient operation of the core processes (like a training process).

Dec 16, 2014

FDA New Guidance on Informed Consent: Updates to Required Elements

by Paul Cobb
Clinical Research Associate, IMARC Inc.

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.   
While the new guidance is, in many ways, an expansion of current practices, there are several aspects that are noteworthy. It’s important to consider the evolution of FDA thinking regarding Code of Federal Regulations (CFR) required elements of informed consent. (21 CFR 50.25)

Dec 11, 2014

How to Address the Top 3 Supplier Management Issues

How to Address the Top 3 Supplier Management Issues
Do you spend time juggling your suppliers? 
Your suppliers should have the systems in place 
for satisfying your quality and regulatory needs. 

by Matthew M. Lowe
Executive Vice President, MasterControl Inc.

Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency—in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

There are a lot of contract manufacturers that are shifting their focus to medical technology due to the stability of the marketplace as compared with the automotive or aerospace industry. While many of them have good intentions, they often don’t understand the complexities of med tech manufacturing.  

Dec 9, 2014

Five Common Issues that could Jeopardize Training Compliance

Editor, MasterControl Insider

If your company is regulated, then you know that it’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work.

“Training is what helps turn the theory of quality into reality,” said Dave Hunter, product management director at MasterControl (1). “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring.”

Dec 4, 2014

Two Keys to Prosperous B2B Customer Partnerships

Two Keys to Prosperous B2B Customer Partnerships
Extraordinary quality management begins with
 remarkable people working together to generate an 
atmosphere that stimulates customer success.
by James Jardine
Marketing Communications

Give the customer what they want. It may be a trite and simplistic aphorism, but it’s one that’s hard to live by in a competitive business world. Yet the companies that stay true to it are always the most successful. That’s because a company that provides products and services to other businesses is only as valuable as the value it supplies. Think of it this way: ‘why’ a company does what it does is even more important than ‘how’ the company does it or ‘what’ it is actually doing.

To create value in the (often highly regulated) realm of quality management systems, one software and services provider has made remarkable strides by concentrating on two core values: customer success and exceptional people.

Dec 2, 2014

A Bipartisan Success at Getting Drugs to the Pharmacy Faster (and Cheaper)

U.S. Food and Drug Administration

Most medications used to be expensive – much more expensive than they are today. As recently as the early 1980s, most important drugs on the market were brand names under patent protection. Generics were uncommon; the cost of developing and marketing them in competition with the big brands was too high. Without change, the relative ease with which most of us get and use prescription drugs today might have been quite different.

Change came in the form of the Hatch-Waxman Act, the law – its 30th anniversary is this year – that established the modern system of generic drug regulation in the United States.  Its original sponsors, Rep. Henry Waxman (D., Calif.) and Sen. Orrin Hatch (R., Utah) brokered a critical bipartisan compromise to ensure the bill’s passage.

Nov 25, 2014

Mind The Gap: Are Training Gaps Preventing You From Closing The Quality Loop?

Mind The Gap: Are Training Gaps Preventing You From Closing The Quality Loop?
Learn five tips for addressing common training gaps.
by Stephanie Jones, Senior Professional Services Consultant, MasterControl
If you follow GxP Lifeline regularly, you’ll notice that we’ve been talking a lot about the concept of closed-loop quality recently, and here’s why. In the face of an increasingly competitive business environment, manufacturers are discovering that traditional approaches to quality management are no longer working (and haven’t been for quite a while). Treating compliance as a series of data or process silos that vary with department or product lifecycle stage simply won’t cut it anymore. A closed-loop approach is what’s needed today because it provides a more holistic view of product and process quality throughout the value chain as well as a considerable competitive advantage.

Nov 20, 2014

It's Not Just You: FDA Regulatory Requirements Really Are Increasing

The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.

According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

Nov 18, 2014

Recognition is a Good Thing

This year, MasterControl was recognized for 
performance excellence by Software Magazine.

by Robyn Barnes
PR Specialist, MasterControl

It’s always nice to know when you are doing well, especially when you’re recognized within your own industry.

This year, MasterControl was recognized for performance excellence by several industry organizations. 

The first accolade came when Software Magazine included MasterControl for the third time in its Software 500 ranking of the world’s largest software and service providers.  MasterControl ranks 369.

"We're very pleased to once again be included in this list of providers," says MasterControl CEO Jon Beckstrand. "This inclusion is an indication of the quality of our product, our customers and our employees."

Nov 13, 2014

MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs

MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs
FDA’s Office of Regulatory Affairs (ORA) is 
expanding its use of MasterControl's software.
by Cindy Fazzi
Editor, MasterControl Insider

The U.S. Food and Drug Administration (FDA) has been protecting American consumers for over 100 years. In the face of increasing global interdependence, the FDA’s responsibility has expanded by necessity; it works with its counterparts throughout the world to help ensure product safety and quality.

The FDA’s emphasis on quality standards is reflected in its vision to dedicate itself to “world-class excellence as a science-based regulatory agency with a public health mission.” The same vision drives the FDA’s Office of Regulatory Affairs (ORA), the lead entity for all of the FDA’s field activities. ORA states plainly its commitment to quality and continual improvement (1). It emphasizes quality within its ranks and applies the same rigorous quality standards it expects from the industry.

Nov 12, 2014

American Laboratories Begins Phase II of MasterControl

American Laboratories Begins Phase II of MasterControl
ALI has been using MasterControl Training and 
MasterControl Documents over the past two years.
American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.  

 MasterControl is used by hundreds of companies worldwide to facilitate compliance management by automating and managing document and change control, training management, audits, corrective/preventative actions (CAPA), customer complaints, nonconformance disposition, deviation handling and other GxP processes critical to regulatory compliance.  

Nov 11, 2014

MHRA Opens One Stop Shop for Regenerative Medicine Information

MHRA Opens One Stop Shop for Regenerative Medicine Information
MHRA is offering one-stop shop regulatory 
advice for life science professionals
 working on regenerative medicines
by Robyn Barnes
PR Specialist, MasterControl

A new ‘one stop shop’ that will provide regulatory advice for those working in the life sciences industry on regenerative medicines has been launched, according to the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA).  MHRA is an executive agency of the Department of Health in the United Kingdom responsible for ensuring that medicines and medical devices work and are acceptably safe.

The service will, for the first time, provide a single point of access to regulatory advice from the four regulatory bodies that work in the sector.

Nov 6, 2014

MasterControl Says “Go Live” to Localized Websites

MasterControl Says “Go Live” to Localized Websites
MasterControl’s international efforts included the 
recent launch of three new localized websites.
by Jason Clegg
Director of Marketing, MasterControl

At its core, website translation is a process that allows everyone across the globe to access the same opportunities and/or products in their own languages. This is especially important to companies like MasterControl that are expanding in to international markets.

 “MasterControl has worked continuously over the last few years to build its international presence,” says CEO Jonathan Beckstrand. “We want everyone to be able to manage safer and more effective manufacturing processes no matter what kind of life-saving product(s) they are invested in creating.”

Nov 4, 2014

Surviving ISO 9001:2015

VP Operations, Oxebridge Quality Resources

The next revision of ISO 9001 is due in 2015, and the standard is being anticipated with more controversy than any previous edition. The document, now in its Draft International Standard (DIS) stage, is nearly a done deal, with very few changes likely before it progresses to its final release.

Despite some online bluster, the changes are not as significant as some would have you believe. Using simple word count comparison against the current 2008 version, we find that 74% of the changed wording was merely rephrasing of existing requirements, without any new requirements; of the remainder, 20% are new requirements mandated by ISO bureaucrats, and 6% is new wording introduced by TC 176. That is good news for those who don’t want to spend a lot of money “updating,” but bad news for anyone expecting ISO 9001 to evolve into a more modern, 21st century standard.

Oct 30, 2014

How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market

Successful product development requires the orchestration 
of multiple complex systems and processes, sometimes 
requiring worldwide coordination.
by Lisa Weeks, Communications Specialist, MasterControl

Having a great product does not guarantee success. The road from concept initiation to commercial release is a long and arduous one. Success depends upon not only understanding the new product development process, but also the FDA submission process, and the complex interplay between the two. Many companies underestimate the value of a carefully thought-out submission strategy. They focus solely on product development and treat the approval process as an afterthought. Others are so eager to get their product to market, they rush the design and testing processes and end up with a product that’s dogged by costly delays or, worse, unmarketable.

Successful product development requires the orchestration of multiple complex systems and processes, including design control, compliance management, and risk analysis/assessment and design and process validation. Is your company’s new product development program equipped to handle all of these elements in an environment that’s constantly changing due to new technologies, regulations and competitive activity? Few are.

Oct 28, 2014

What Is Driving More Organizations to Plan an EQMS Adoption?

What Is Driving More Organizations to Plan an EQMS Adoption?
Planned EQMS adoption rates are accelerating 
as the tech matures. What are key drivers
 behind this growth?

by David R. Butcher, Marketing Communications, MasterControl

In response to increased pressure to simultaneously meet compliance, mitigate risks and improve cost savings, a growing number of organizations are taking steps to transform their quality management by adopting enterprise quality management software (EQMS). Research indicates that approximately 40 percent of companies are currently planning to implement an EQMS solution. What are the key drivers behind the rising number of companies moving toward EQMS adoption?

Oct 23, 2014

From Good to Great – the One Skill Great CRAs Possess

From Good to Great – the One Skill Great CRAs Possess
To be a great CRA, one skill is needed:  active listening.
by Holly Deiaco-Smith, MS

What skill differentiates a good clinical research associate (CRA) from a great CRA?

a.  Knowledge of clinical processes and the regulations that govern them?
b.  Ability to be flexible with travel and work schedules?
c.  Ability to spot errors that could gravely impact data and ultimately patient safety?
d.  A relentless zeal for ensuring assigned sites are “buttoned up?”

The answer- none of the above. 

Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

Oct 21, 2014

Evaluating the Effectiveness of a Corporate Compliance Program: A Holistic Approach

Dahl Compliance Consulting

Now more than ever, pharmaceutical companies must not only have an effective corporate compliance program in place, but senior management and boards of directors at these companies must ensure that they evaluate the effectiveness of those programs.  The best reason to evaluate the effectiveness of your compliance program is so that you know whether or not the program is managing the particular risks facing your company.  If you are responsible for protecting your company from risk, shouldn’t you want to know that your compliance program is working?

Oct 16, 2014

Why Food Makers Are Investing In Food-Safety Software

Why Food Makers Are Investing In Food-Safety Software
by Sam Lewis
Associate Editor, Food Online

Throughout 2014, food makers have put forth significant efforts in pursuit of food-safety and quality-management software solutions. But why is there so much interest and effort in these systems now?

The Obstacle Of Paperwork

To put it bluntly, handling paperwork is a burden that creates more problems than it solves. A misplaced invoice, a forgotten signature, an accidentally destroyed document… all of these scenarios can wreak havoc on a quality-manager's workload. Not to mention the bottleneck it creates on workflow. Developments in supply-chain management, fraud prevention, and food safety are only extending and complicating the labors of safety officers. Fortunately, software solutions and automated processes are able to take on these added tasks and ease the minds of safety and quality-assurance workers.

Oct 14, 2014

FDA vs. EU Inspections: Similarities & Differences

IPRF, LLC – RA/QA Consulting & International Product Registration

EU-FDA Joint Initiative

The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009.  This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).

These joint GCP inspections come under an arrangement between the European Commission, the European Medicines Agency (EMA), and the FDA. The initiative allows them to streamline the sharing of information on inspection and observations and facilitates the conduct of collaborative inspections. The goal is for European Union (EU) inspectors and FDA inspectors to have the same information about a facility. 

Oct 7, 2014

INFOGRAPHIC: U.S. Manufacturing Facts and Figures

by David R. Butcher, Marketing Communications, MasterControl

Last Friday marked the third annual Manufacturing Day (MFG DAY), a growing grassroots movement of manufacturers dedicated to bringing attention to modern North American manufacturing and empowering the professionals who compose it. Here we highlight some of the contributions of U.S. manufacturers to the nation’s economy.

Since 2012, manufacturers all across the United States, U.S. territories and Canada have opened their doors to the public on the first Friday of October, and often throughout the month. Organized by the Fabricators & Manufacturers Association (FMA), the National Association of Manufacturers (NAM) and the National Institute of Standards & Technology’s (NIST) Manufacturing Extension Partnership (MEP), MFG DAY is designed to highlight new technologies and innovations, address common misperceptions about the sector and inspire the next generation of manufacturing professionals.

Oct 2, 2014

The 3 Biggest Project Management Problems in the Regulated Environment

Lead, Solutions Consultants Group, MasterControl Inc.

Effective project management helps your company save time and money by keeping projects on time and on budget. It optimizes your resources by assigning the right people with the right skills for every project. In a regulated environment, you need all of these, plus one more crucial consideration: compliance.

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Health, Labour and Welfare (MHLW) in Japan expect companies under their jurisdictions to have a formal project management plan that addresses relevant requirements, design control, and change control, among other things.

Sep 30, 2014

5 Tech Support Life Hacks for Better (and Fewer) Support Calls

5 Tech Support Life Hacks for Better (and Fewer) Support Calls
Calling tech support doesn't have to 
ruin your day. Really.
by Eric Weeks 
Technical Account Manager, MasterControl

Life hacks, which are practical tips or shortcuts that help you get things done faster and more efficiently, are all the rage these days.  A quick Google search reveals hacks for overcoming many of life’s pesky obstacles or frustrations—from how to keep a pot of water from boiling over (place a wooden spoon across the top it) to how to light a candle wick without burning  your fingers (use a dried spaghetti noodle).

For some users, calling tech support is considered to be one of those hack-worthy frustrations.  With this in mind, I’d like to suggest some handy hacks to make your interactions with tech support, whether you’re calling about software, hardware, or technology in general, smooth and less stressful. They may help you avoid having to call at all. 

Sep 25, 2014

Understanding the Relationship between GMPs and Adulteration

GMPs are policy goals that do not specify how an 
activity is done, just the result it should achieve. 
The name  also lacks any link back to the overarching 
purpose of the practices.

by Marc C. Sanchez
Contract In-House Counsel & Consultants, LLC  

Good Manufacturing Practices (GMPS or cGMPS) are a bit of a misnomer. The name implies the practices only apply to manufacturers, but the limitation is in name only. It suggests a rigid system of procedures more suitable for multinational corporations than start-ups, mid-size companies, or importers. In truth GMPs are policy goals that do not specify how an activity is done, just the result it should achieve. The name also lacks any link back to the overarching purpose of the practices. GMPs are not a scoring or rating system. Instead GMPs are a crucial link to avoiding adulteration and ensuring quality. The practices set a floor or safety net of minimum facility sanitation practices to ensure cosmetics are not indirectly contaminated. It also establishes a consistency that secures quality. GMPs are oft cited by the FDA following facility inspections in Form 483s and Warning Letters because it provides a window into the culture and compliance mindset of a facility. That mindset suggests the likelihood of adulteration or larger compliance violations. 

Sep 23, 2014

Why Do Corrective Actions Fail?

Why Do Corrective Actions Fail?
There are two fundamental reasons why 
most corrective actions  programs fail.
by Ed Grounds, President
Integrated Solution Providers Software, Inc.

Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?”  Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing.   Normally, we turn the question back around to the group and ask them why they think their corrective action program fails.  The most common answers we hear are:  limited time, resources, training, or not knowing which tools to use.

Sep 18, 2014

The Nine Elements of Lean Configuration

The Nine Elements of Lean Configuration
Nine elements comprise the Theory of Lean Documents
by José Ignacio Mora, Owner, 
Atzari Enterprises, L.L.C.

The allure of finally terminating your paper quality management system (QMS) feels very liberating. You can see the excitement in everyone's eyes during the new QMS software presentation.  Gone will be the days of paper engineering change notice---everything will be circulated and approved electronically and finally everyone will have time to do their jobs. They can hardly wait to tell their cubicle buddies about the new world they will soon live in.

Nine months later into the three-month project ...

Sep 16, 2014

Communicating Priorities to Your Employees

SVP, Marketing
MasterControl Inc.

Needless to say, if managers don’t understand corporate priorities, they can’t communicate them to employees. Entire departments may pursue the wrong priorities, causing stra­tegic corporate plans to become less effective. I’ve seen a lot of this. Likewise, if managers understand the priorities, but have not communicated them well to their departments, the results can be the same. And if employees are left to themselves to decide what the priorities are, not only are the efforts of your teams unlikely to match corporate goals, they probably won’t even match each other. You will likely have employees working in different directions, even within the same departments or even on the same projects.

Sep 11, 2014

INFOGRAPHIC: Closed-Loop Quality Management and the Cost of Inaction

by David R. Butcher, Marketing Communications, MasterControl

In today’s global manufacturing environment, continuing to rely on outdated, siloed quality management technology comes at a cost that many regulated companies simply cannot afford, new research indicates. That is why leading manufacturers are taking quality management further, leveraging EQMS to develop closed-loop quality processes that track quality throughout the value chain.

Sep 9, 2014

6 Best Practices for Enterprise Solutions Implementation

by Kevin Ash, Senior Vice President of Services, MasterControl

Investing in a powerful software solution can be extraordinarily valuable to your organization, yet the effort is wasted if it is not implemented effectively. To help ensure a smooth and successful implementation process, consider these six best practices.

All enterprise solutions implementations are unique, comprising their own complexities and challenges due to the technological and organizational change involved. However, there are certain requirements that are essential to the success of any implementation project. To improve the likelihood for success in an implementation project, consider the following best practices, based on MasterControl’s 90 percent implementation success rate among life sciences customers.

Sep 4, 2014

Choosing the Right Drug Name: How to Increase Your Chances for Approval

President, Med-ERRS

The pharmaceutical industry is all too familiar with how exceedingly challenging it can be to achieve a viable trademark that is accepted by the health authorities, especially if obtaining a global mark is the end goal. Over the past few years, health authorities in several countries have been developing their proprietary name guidances. In the last six months alone, both Health Canada and the FDA released guidances pertaining to proprietary name development – Health Canada’s proprietary name guidance was finalized and FDA released its first-ever initial draft guidance on the topic of name selection and development. Industry is now curious to learn how these guidances will affect their current trademark development and selection process and their trademark’s chance of approval.

Sep 2, 2014

FDA Issues New Q&A On Data Integrity

FDA Issues New Q&A On Data Integrity
FDA recently published a new set of seven questions 
and answers targeting GMP but applicable to 
anyone working in quality assurance.
by Jamie Colgin, Colgin Consulting, Inc.

Reprinted with permission from Colgin Consulting, Inc.

Recently FDA published a new set of seven questions and answers. Three questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us: 

Aug 28, 2014

What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan

What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan
How do you know the prescription drugs 
you take are safe and not counterfeit?
by Peter Knauer, Senior QCC Consultant, MasterControl Inc. and 
Moj Eram, Regulatory Consultant

This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.1

Since the formation of the first FDA Counterfeit Drug Task Force in 20032, the agency has been engaged in efforts to improve and enhance the security of the drug supply chain at multi-level efforts that involves all stakeholders. The aim is to protect U.S.  patients from ineffective, counterfeit, low quality and unsafe drugs that enter to the market. Counterfeit, mislabeled, adulterated, or otherwise compromised prescription drugs pose serious public health safety concerns that are being addressed through the new Act. These drugs may be contaminated or contain faulty ingredients, inaccurate dosage, inactive ingredients or toxic ingredients. As a result of these drugs entering the market, patients risk their health by unknowingly using these faulty products.

Aug 26, 2014

Regulatory Records Primer Part 2: Decoding the Requirements for Pharmaceutical Manufacturers


In Part 1 of the Regulatory Records Primer (Decoding the Requirements for Medical Device Manufacturers), I discussed the general requirements and thought processes undertaken by the FDA with respect to regulatory records.  While the drug side has not yet “evolved” to using a quality systems approach to the regulatory requirements, the same basic process holds true.  Following is a discussion on the regulatory records required to be maintained by manufacturers of finished drug products.

Aug 21, 2014

Regulatory Records Primer Part 1: Decoding the Requirements for Medical Device Manufacturers

Regulatory Records Primer Part 1:  Decoding the Requirements for Medical Device Manufacturers
Records, either paper or electronic,play a vital 
role in FDA’s ability to confirm that procedures 
have been appropriately implemented 
by Les Schnoll, Quality Docs, LLC


The Quality System Regulation (QSR) is premised on the theory that the development, implementation, and maintenance of procedures designed to carry out the requirements of the regulation will assure the safety and effectiveness of medical devices.  Therefore, it is easy to see the importance of the records required to document the implementation of those quality system procedures.
One of the basic themes of the Quality System Inspection Technique (QSIT) (used during inspections of medical device manufacturers) is the “Establish Test.”  The QSR requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.”