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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: