| 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
> |
