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Did you also know that many of the negative symptoms experienced by blood transfusion patients could be avoided with further research and joint projects sponsored by private entities, the American Association of Blood Banks and the Centers for Disease Control and Prevention?
Does your company have a CAPA problem? CAPA problems aren't just a quality problem but a business problem that can reduce your ability to compete and innovate. Inside the organization they become everyone's problem and they often result from an "open-looped" CAPA system.
Take for instance a company that has a workable CAPA management solution but is not gathering and recording all the initial issues and events that according to the FDA need to be gathered and reported.
That 21 CFR Part 11 has a retention requirement for audit trail documentation?
Many companies seek the expertise of BPOs. Business Process Outsourcers have, in many cases, shown that the BPO model can save companies significant expense. However, a recent survey conducted by ASQ shows that those company representative respondents aren't expressing the satisfaction they'd like to express in their respective BPOs.
Why is it that quality professionals have "escaped" the jaws of an unpleasant economy? There are a variety of participating factors but when all is said and done quality professionals have come out on top.
MasterControl's All Access solution is designed for life science professionals who need integrated, specialized solutions that address the many challenges in their unique work environments; for those professionals who have difficulty convincing management to invest in expert tools that would save the company money; for those who find that it's not cost effective to invest in general purpose tools that you only use once in a while; and for those who require a complete quality management system (Q
This article was originally published in the August 2011 edition of EduQuest's publication: EduQuest-ions & Answers.
Why target adherence to Part 11 requirements?
Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or as part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer w
CAPA is a critical Quality System subsystem that, when executed correctly, can provide your organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency.
The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.
Compliance and business risk plays a significant role in the implementation methodologies of corporate information systems. Further, the compliance and business risks associated with these corporate information systems are, in general, well known. However, as part of the implementation process many of these information systems will be populated with legacy data. The compliance and business risks associated with migrating this legacy data and content into a new system are not necessarily understo
A common biotech business model is to have a lean and fast virtual organization. These organizations are established with experienced professionals who have a wide breadth of entrepreneurial experience and experience within the pharmaceutical, biotechnology or even medical device sectors. These organizations also have innovative products that are to be developed to the next inflection point, which is usually a step to reduce further developmental risk. The product can then be moved on toward r
Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. A
Especially for users of paper-based quality systems, it's hard to believe that it's been close to 25 years since companies first began using computers to facilitate their regulatory obligations for maintaining quality systems. Throughout this 25-year period, there has been extraordinary progress in technology, features, functionality, and scope of the solutions; along with an equal amount of disappointing results and unrealistic expectations. Many companies over the years have spent small (and
Globalization of the marketplace has greatly intensified competition and has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.
The term "change" is something that we all experience both in life and in our business. While some of us might embrace it and seek the challenges, there are often more that do not like it and are resistant to the implications that change may have. The big difference between the two attitudes is that in life, we face the change, accept it and move on. We do not formalize the event by a series of documents, reviews, evaluations and approvals. In regulated industries, such as pharmaceuticals, biote
Note: A long-running discussion in the LinkedIn ASQ Group about the significance of certification led us to ask this employment expert about the value readers receive from advanced degrees and certifications, particularly in a highly-competitive job market like life sciences.
It is impossible for FDA-regulated manufacturers to conduct business without paying close attention to regulatory compliance.
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