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ValSource can provide a full range of Validation and CGMP related services
from protocol preparation and field execution to project management, training,
and cost control. The following is a list of services which we provide. Simply
click on a title to view a brief summary of the service. Please feel free to
contact us for any additional information.
Validation Project
Management
Validation Master
Plan Preparation
CGMP Training
and Audit Preparedness Training
CGMP Audit and Consulting Services
Protocol Preparation:
IQ/OQ/PQ
Protocol Execution:
IQ/OQ/PQ
Report Preparation:
IQ/OQ/PQ
Computer Validation
Commissioning and Startup Support
Continuing Validation
Validation Project Management
We can provide proven, experienced validation project managers that
have the training and expertise to get your project done on time,
within budget, without sacrificing quality.
Validation Master Plan Preparation
When you need a validation master plan to help you get it all
together, or if you think your current validation master plan
may need some improvements, we have the people you can rely on
to get a quality job done. Our validation experts have prepared
validation master plans for many of our clients, and are familiar
with the ever-changing regulatory environment.
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Services
CGMP Training and Audit Preparedness Training
If you need quality CGMP training, or have an upcoming audit,
we can help. Our expert trainers have the skills necessary to
teach your employees basic and advanced CGMP concepts that are
applicable to your product and processes in a short course.
Employees will learn the important elements of current GMP's, and
will learn how to interact with regulatory authorities. For
employees with previous CGMP training, we offer refresher courses
that cover recent changes in the regulatory climate that affect
your company.
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CGMP Audit and Consulting Services
As CGMP requirements change, and regulatory expectations of
manufacturing requirements increase, it is difficult to know
if your facility is keeping up. ValSource
Consulting Group can offer experienced auditors, which have been
through FDA, MCA, and other audits; to give you
a head's up on what might be issues with your facility. Our
auditors are trained not only to be able to find potential problems,
but also to suggest the most cost-effective ways of resolving the
problems. Our auditors keep a finger on the pulse of the regulatory
environment so you don't have to.
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Protocol Preparation: IQ/OQ/PQ
Our validation consultants are skilled protocol preparation
experts. We work within your documentation system, using your
templates and formats if you have them, or we will custom tailor
a format to fit your needs. We are familiar with all aspects of
equipment and computer validation. We are skilled at producing
quality documentation on time and within budget.
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Protocol Execution IQ/OQ/PQ
We have the trained validation staff to help you execute
validation protocols. Our validation engineers are skilled in
computer validation, equipment qualification, SIP and CIP, and
are skilled problem solvers, familiar with the problems that can
occur during execution and the techniques that can be used to
ensure that a project is completed on schedule and with a high
attention to quality detail.
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Report Preparation: IQ/OQ/PQ
Often one of the most difficult aspects of validation projects
is the report writing. In a time when turnover of validation
personnel is high, often execution is finished by one employee,
and the report doesn't get written before they leave. Our
engineers are able to pull the data together and get quality
reports out quickly, even if someone else performed the work.
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Computer Validation
As technology and automated systems are rapidly
advancing in the pharmaceutical, biotech and medical device industries,
our computer validation engineers can work independently or within your
computer validation department to ensure that all of your computer
systems meet regulatory requirements.
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Commissioning and Startup Support
Our engineers have the experience to tie all aspects of
start-up of a new facility together. ValSource has a
proprietary software system, which collects and manages
engineering information throughout the design and construction
effort. This information is used to automatically generate the
validation protocols with the most up to date information
pre-printed in the document from the database. Our technical
experience can help you in all aspects of facility development,
from cleaning agent selection to SIP system design.
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Continuing Validation
An important aspect of CGMP requirements for validation is the
necessity of periodic revalidation. ValSource can set up and
operate a revalidation program to maintain a constant state of
validation compliance on all of your essential equipment.
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