White Papers and Articles
Check items you wish to view and then click submit at bottom of form

White Papers
Regulatory Asset Management: Harmonizing Calibration, Maintenance and Validation
Calibration, maintenance and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected systems made sense. However with new regulatory pressures and in search of greater productivity and efficiency, leaders in the life science industries have explored and experimented with different ways to harmonize these systems. Until recently, the available options have required significant compromises to be made. This paper discusses the evolution of the driving forces and the available solutions for harmonizing calibration, maintenance and validation, concluding with the latest technologies designed to eliminate the need for the departmental compromises previously required to achieve harmonization. View >
   
Justifying an EAM System in the Life Science Industries
People who live and breathe maintenance every day are instinctively aware of the benefits of maintenance improvement: lowering costs and increasing output while still remaining compliant. The intent of this paper is to provide a framework for building the formal justification for investing in a CMMS (Computerized Maintenance Management System) or EAM (Enterprise Asset Management) system as part of a maintenance management improvement initiative. View >
   
10 Tip for Avoiding CMMS / EAM System Failure in the Life Science Industries
In the regulated life sciences industry failure to meet expectations can not only bring down reprimands from senior management, who themselves are often complicit in the failure, but also can evoke the “attention” of the FDA or other international regulatory agencies. Fortunately there are 10 simple tips to follow for a successful CMMS or EAM system implementation.View >
   
CCMS Best Practices: making the most of limited calibration resources
This paper explores the calibration management system features and functionality common to best-in-class calibration management applications designed for life sciences. These features are demanded and used by some of the world’s most successful pharmaceutical, biotech and medical device companies and are intended to improve productivity and lower the costs and risks associated with compliance. Why are they so important to these companies? What are their benefits? How can you justify the time and energy required to learn to use these features and implement them? View >
   

When to Upgrade:
Balancing Benefits of New Systems With Costs to Upgrade

Not sure when to upgrade to new technology and software? Having difficulty convincing others that the time is now? This white paper examines the following topics, primarily for life science companies:

 
  • The regulatory pressures that promote and discourage upgrading
  • The features in new systems that reduce risk and improve productivity
  • Ways to reduce costs and risks associated with implementing and validating a new system
  • Guidelines for weighing the benefits versus the costs of upgrading
  • Examples specific to calibration and maintenance management systems View >
   
Improving Employee Performance and Compliance
in the Life Science Industries

Well-trained and resourceful employees are a well-known key to success for any company. Additionally, as demonstrated by some recent consent decrees, the FDA and other regulatory bodies have certain expectations about the level of training and demonstrated ability of key personnel at life science companies. Attention to employees, including their quality of performance skills and their diligence to compliance issues should warrant a place of importance in the company culture. View >
   
Minimizing Calibration Risk in Complex Biotech Environments
The importance of careful calibration management is made evident by the nature of risks that derive from poor calibration management, including scientific, regulatory and ultimately business risk. The biotech industry's risks in each of these cases are unique. Understanding these risks, the unique complexities of the biotech industries, and the strategies and tools available to reduce those risks, is important in minimizing and controlling those risks and their associated costs. View >
   
GMP Calibration Software Implementations:
Containing Costs and Managing Risk

As expectations from and complexity of calibration management software implementations increase, many leading regulated Life Science manufacturers have chosen to outsource some or all of these implementations. The issues propelling this decision include:
 
  • Increased expectations to reduce risk and contain costs
  • Desire to achieve the full productivity benefits offered by calibration management software
  • More thorough system life cycle regulation by the FDA
  • More stringent validation requirements
  • Greater pressure on time and personnel limitations
  • More sophisticated systems requiring more varied expertise View >
   
Validation of a Calibration Management Software System
It is prudent to select a validation process that produces the highest level of compliance with the minimum of resources. This paper identifies 3 key aspects to implementing & validating a CMS system. The basic aspects identified in this paper are based on Blue Mountain Quality Resources’ experience in implementing over 1,000 FDA calibration management software systems. The first two aspects, the User Requirements Specifications and Software Vendor Qualification provide the ground work for the third aspect, the Validation. View >
   
Application of Electronic Records & Signatures in Calibration Management Software
Effective August 20, 1997, the Food and Drug Administration (FDA) issued 21 CFR Part 11, setting forth criteria under which the agency will accept, under certain circumstances, electronic records and electronic signatures. Part 11 allows firms to take advantage of electronic technology, and to have electronic records considered equivalent to traditional paper records.
View >
   
Articles
Asset Management for Growing Biotech Companies
published in BioPharm International
As biotech companies grow, either as treatments progress through the development and marketing process or through success of a marketed product requiring new production capacity, they face unique challenges and opportunities in all areas, including asset management. The volume of instrumentation increases and new regulations for the management of assets apply at more advanced phases. To meet the complex demands involved in maintaining and managing the validated state of equipment and processes, a single unified approach to calibration, maintenance and validation makes the most sense. View >
   
Establishing Global GMP Compliance with an Enterprise Calibration Management System
published in Pharmaceutical Technology
Driven by tough FDA enforcement, attention to GMP compliance is at an all time high. In addition to having the responsibility for complying with increasing regulatory requirements, pharmaceutical manufacturers must find ways to improve their productivity. As a result of mergers and acquisitions, worldwide markets, and the complex nature of the drug development, the need for cost-effective global compliance has never been more important. View >
   
Implementing a Calibration Management System at a Life Science Company published in Quality Digest
The FDA has detailed regulations for the implementation of systems in life sciences that should be understood and managed when considering new technology. View >

© Blue Mountain Quality Resources, Inc.
The Blue Mountain Quality Resources, Inc. logo, Blue Mountain Regulatory Asset Manager and Calibration Manager are registered trademarks of BMQR, Inc.
Products ~ Services ~ Calibration Management ~ Maintenance Management ~ Quality ~ Engineering ~ Implementation ~ Enterprise Asset Management
CMMS Software ~ Industry ~ Support ~ Resources ~ Maintenance, Calibration and Quality Webinars ~ Company ~ Contact Us ~ Site Map