Marci L. Crane
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Articles by Marci L. Crane
September 25, 2009
In most industries customer complaints management is considered an important aspect of a company´s quality system. Customer complaint software is designed primarily to automate processes associated with basic customer complaint management. For example, customer complaints in many companies are received via email, phone, fax, letters, etc. but can be more effectively received and managed via a centralized platform that allows users to receive customer complaints and store any related documentation in a secure environment.
July 25, 2009
There are a few reasons small businesses should consider the purchase of a document management system. Some of the more obvious reasons include businesses that are unnecessarily paying employees to organize, file, retrieve or deliver paper-based documentation, or businesses that have experienced set-backs that can be "traced" to paper disorganization or manual file mishaps. Another fairly obvious reason is that document management systems are one of the first steps small businesses can take to play the "big guys" on a more level playing field.
July 16, 2009
Today's manufacturing companies that seek ISO 9001 compliance-(regardless of their motivation to do so) probably don't find it that difficult to create intelligent documentation. After all, a few days with a good consultant or a quality manager can take care of document creation. The problem lies in the gap between what employees are doing and what employees are supposed to be doing (in terms of adhering to documentation) and the gap between the manner in which processes are being implemented and the manner in which they should be implemented ( in accordance with documentation).
June 27, 2009
It's scary how some document control software systems sell themselves as the "best of the best" when they can't even provide some of the simplest of elements mentioned in this article.
June 20, 2009
With a global reach, ISO 13485 (2003) standards require the support for and the implementation and maintenance of a quality management system in all medical device environments that wish to achieve ISO 13485 Certification.
June 13, 2009
There are four simple regulations-supported reasons that medical device engineers, developers, quality managers and executive managers should invest in a document control software system that does more that control documents.
April 30, 2009
Most companies don't manage and control their documentation for the sole purpose of complying with SOX regulations, with ISO standards or with the FDA, but it doesn't hurt to consider your regulatory needs when you're "in the market" for a web-based document control system.
April 18, 2009
All life science companies should do their due diligence in terms of the web document management and QMS CAPA technology that they implement in their environments.
April 17, 2009
When the regulatory crowd hears the phrase "web document management" they can relax and know they are in good hands. After all, web document management is simply a managed organization of documentation a virtual protected environment to keep that documentation until it's ready to be formatted for regulatory submissions, etc. On the other hand, when regulatory professionals hear the phrase "web document control" it probably isn't uncommon for them to silently scoff or subtly turn up his or her nose at the "pick-everything-apart" quality way.
April 09, 2009
Open source software solutions are becoming increasingly common and like certain fast food restaurants (no names will be provided of course), are unbeatable when it comes to "the current culture." After all, everyone loves a good open source solution. It's so valuable and so….well, F.R.E.E.
March 18, 2009
When a company meets web document management for the first time it says "Pleased to meet you." Actually, it says, "Very pleased to meet you," and it's no surprise that the company's apparent felicity is sincere.
March 11, 2009
Paper-based processes result in bottlenecks: collaboration bottlenecks, revision bottlenecks, routing bottlenecks, version-control bottlenecks, tracking bottlenecks, auditing bottlenecks, reporting bottlenecks, training bottlenecks, etc. It's easy to see and to clearly envision that a solid web document management solution--in conjunction with a learning management solution--can easily save MOUNTAINS of time by clearing sound pathways where multiple bottlenecks once existed.
February 27, 2009
Compliance, in our world today, effectively refers to standardization plus transparency. Standardization refers to processes that are predictable and transparency refers to the means of easily tracking said processes. Both standardization and transparency require technology enablers: standardization requires enablers because rote processes cannot be maintained without technological means (unless unfailing resources exist) and transparency requires enablers because high-level accountability is literally impossible to achieve without it---unless of course, everyone were 100% honest.
February 27, 2009
Within the current zeitgeist, the phrase "open source" correlates to the "current virtue." After all, what's more virtuous that "free"1? Developers love it (okay not all of them) and, in fact, they are more likely to drop down and drool at the idea of open source programming than anyone else. The question however is how do their business-oriented counterparts respond to open source solutions? It's an important question, especially in terms of web document management technology enablers, which are absolutely essential for high-stakes businesses such as medical, legal or research enterprises.
February 21, 2009
It may be helpful to think of web document management as primarily concerned with the management of documentation as opposed to web document control, which, as will later be shown, is primarily concerned with the control of those who would--or would try--to manipulate that same documentation.
February 21, 2009
Web document management, though not quite ubiquitous in every industry, is quickly becoming a standard tool, especially in regulated industries or industries that maintain high standards of document management and control.
February 20, 2009
When it comes to web document management software systems, there are two basic models that can be entertained in terms of where the solutions will be hosted: 1) the premise-based web document management system and 2) the SaaS (Software as a Service) model. Both system types have their advantages and disadvantages (see "Advantages" sections below) but the surprising thing about the premise-based and SaaS models are the myths often associated with each model.
February 13, 2009
Short-span patent lives and shrinking "jackpots" are forcing pharmaceutical executives to take a second (or a third) look at philosophies associated with lean manufacturing, Six Sigma and the ICH Q10 guidelines recently published for purposes of harmonization between the US, UK and Japan, as well as between other countries where pharmaceutical manufacturing or outsourcing is likely to take place.
Web Document Management During Preclinical and Clinical Phases of Pharmaceutical/Biotech Development
February 13, 2009
The preclinical and clinical phases of drug development are obviously essential to the realization of a successful pharmaceutical. However, for many small and mid-sized pharmaceutical companies these phases are especially crucial since drug pipelines (at this stage of development) are either meager or immature. In short, these companies haven't reached the "tipping point" of success, which in the pharmaceutical industry unfortunately often comes later rather than sooner.
February 06, 2009
The first steps of searching for a web document management solution actually have nothing to do with software vendors themselves (no matter how reputable they are).
February 05, 2009
With ideas and products that can make a difference, start-up medical device companies have a story to tell and are aren't afraid to tell it. Despite their brilliance, however, many start-up medical device companies frequently fail to create the basic foundation that is often required for the creation of an organization that 1) attracts potential mergers, or that 2) smoothly transitions into enterprise-level growth. This foundation, though simple in nature, often becomes a drag--a "boring" endeavor--clearly not enjoyed by engineering and/or most management executives.
Enterprise Web Document Management in the Pharmaceutical Industry: Planting the Revenues of Tomorrow
December 31, 2008
It is apparent that web document management within the pharma industry in absolutely necessary and that enterprise-level web document management solutions come even more highly recommended.
December 31, 2008
Because documentation is the foundation and assurance of an accurately applied quality system it is probably safe to assume that those companies that manage and manipulate their documentation faster and more effectively at the enterprise level have an increased ability to more effectively manage their overall quality system.
December 31, 2008
An effective quality system may require many integral processes that function together for best results. These processes may include audits, change control procedures, customer complaints management, etc. They may also include CAPA management processes, or in other words, Corrective and Preventative Action procedures.
January 02, 2009
It is highly unlikely that growing medical device companies will invest in expensive ERP systems and massive DMS solutions. However, a growing medical device company has the need to start streamlining systems from the point of start-up, or at least from the point of multiple-product marketing.
October 30, 2008
From the R&D phases to marketing and advertising, documentation is required by regulations and encouraged by standards (e.g., ISO). Every form of documentation, especially in highly regulated companies such as pharmaceutical organizations, should be stored in a web document management system and should be accessible only by approved users.
October 03, 2008
Marci Crane is a copywriter at MasterControl in Salt Lake City, Utah. For more information about web document management in pharmaceutical environments, please feel free to contact a MasterControl representative.
August 28, 2008
Why aren't life science professionals investing in the technology enablers (e.g., web document management software) that make GCP regulated environments more effective?
August 08, 2008
DHF (Device History File) management is required by the FDA's QSR. Web-based DHF and web document management solutions can help save medical device companies thousands of annual administrative hours more effectively spent on design and development processes.
August 01, 2008
Biologics companies currently employ various technologies but do they have the technology schematic that results in a satiated bottom line?
July 25, 2008
Marci Crane is a copywriter for MasterControl, a provider of GxP process, quality audit and web document management software. To learn more about these software solutions, please feel free to contact a MasterControl representative.
Avoiding Corporate Risks and Hazards with Web Document Management Software: Special Applications for
July 14, 2008
Discusses the financial losses suffered by life science companies loyal to manual documentation control processes and the contrastive benefits of investing in web document management software.
Web Document Management and a PDM Interface for Better CAD File Management: A Competitive Edge for M
June 21, 2008
For those medical device companies that have already implemented web document management software in their own regulated environment and have seen the benefits of a healthy ROI, the question arises as to what IT solution will hold the next competitive edge in the race for the biggest slice of the industry´s revenue and profits.
June 07, 2008
Pharmaceutical companies are in a period of great opportunity and should be implementing less administrative man power and more time into research and development. The right software solutions can allow pharmaceutical companies a greater opportunity to do so.
June 07, 2008
Perhaps medical device professionals should consider up close the multitude of hassles that can be avoided with web document management software.
May 09, 2008
Is CLIA compliance management sucking the time, money and energy out of your clinical lab? Find a system that automates many of the administrative tasks associated with CLIA and provides a sensible ROI.
May 10, 2008
Pharma companies are leaning toward the FDA´s Quality by Design Initiatives and away from batch processing and empirical product testing. What do these changes hold in store for quality control techniques and practices?
May 03, 2008
Quality system design is an essential foundation for successful quality management, but quality systems training—for all employees--may be the key to successful implementation and maintenance.
May 03, 2008
For quality management personnel in regulated pharmaceutical environments, maintaining a high-functioning quality system can add serious burdens to a company´s bottom line. However, with solutions that automate rote and administrative tasks associated with quality system maintenance the ROI can be considerable.
April 26, 2008
Interested in developing a more efficient quality system? Developing a quality system implementation plan that corresponds to ISO 9000 requirements may be a step in the right direction.
April 26, 2008
Why is design the most crucial aspect of a medical device company´s quality system?
April 26, 2008
For most companies, management and investigating customer complaints is recommendable but for CLIA regulated laboratories complaint management is vital to business success.
April 25, 2008
Learn about 6 features that life science professionals should look for in a change control software solution.
April 19, 2008
It takes a study sponsor, facility management personnel, a study director and a quality assurance unit to run a non-clinical safety study.
It takes a quality system to automate their routine processes.
April 19, 2008
Interchangeable parts and increased measures of quality control have changed the evolution of medical devices. Today, for example, advanced methods for parts and iterations management call for a BOM (bill of materials) but even a BOM can be difficult to control if not managed carefully.
April 18, 2008
Various aspects of document protection are essential to CLIA compliance as are additional training, change control and CAPA requirements. Learn more about compliance with CLIA and learn to identify what compliance problems merit automated solutions.
April 17, 2008
Interested in learning more about the basics of ISO 9001, 9002, and 9003?
April 05, 2008
Sometimes it seems like regulatory agencies (FDA, ISO, etc.) are too controlling. When it comes to change control processes however, regulatory agencies often say very little. Why is it then that change control related 483s issued by the FDA continue to be distributed at such prolific rates?
April 05, 2008
QSR change control or change control regulated by the FDA´s 21 CFR Part 820 regulations is the ideal (or currently ideal) template for change control management. QSR change control processes and change control processes unique to individual medical device companies can also be effectively automated.
March 29, 2008
SOPs throughout the quality system seem simple enough to write and manage but the FDA continues to find fault with SOPs and with company deviations from SOPs. How can companies write more effective SOPs that employees aren´t hesitant to follow?
March 28, 2008
Life science quality assurance teams may wonder if their respective change control systems are "up to par". Two elements to consider during a change control system analysis may be the relative simplicity of the system itself and the willingness of employees to participate in it.
March 28, 2008
Change control is more than the management of unexpected change. A change control system should, in addition, be designed for the full and complete coverage of proposed and planned changes.