The FDA is changing the
way it oversees drug quality.
FDA commissioner Lester
Crawford states "We expect
to achieve greater research
efficiencies, easier data
management and lower costs".
See article in Next Generation
Pharmaceutical, p.135.
Services
Quality validation services for the pharmaceutical industry
High quality standards mean we pay attention to details. High integrity
standards mean that you come first. Industry experience means we meet
the standards.
Validation Services
Our quality validation services ensure that your validated system meets
the FDA guidelines.
1. System Validation is a FDA requirement. Is your system validated
according to FDA regulation and guidelines?
2. Validation is a monumental task. Do you know what is involved in
Computer System Validation? Do you have the time?
3. FDA is knowledgeable. Will your validation effort withstand a FDA
audit?
What Else Should I Know? Validation does not only ensure compliance to FDA regulation and
guidelines, but it ensures that your business needs are being met.
Our validation methodologies ensure that your computerized system is
compliant, reliable, accurate, robust, and effective in meeting your
business and regulatory needs.
What is Computer System Validation?
Youve heard it by now. The FDA is no longer tolerating non-validated
computerized systems being used in a regulated environment. But what
does it really mean to have a validated system? What needs to be done to
ensure 21 CFR Part 11, part 203, part 205, part 210, and part 211
regulations are met?
Computer System Validation is documented evidence that the system does
what it purports to do.
1. First we need to determine what you have. Have your systems been
previously validated? To what degree? Is there documented evidence your
systems were validated? We will provide a detailed Gap Analysis report
that describes where you are and where you need to be in terms of
validation.
2. Project Management. Validation can easily slip out of control,
especially when the day-to-day operations are demanding. We will provide
an integrated project timeline and project management services to ensure
that your validation effort stays on track.
3. Validation Flow. From requirements gathering, to design and
implementation, to final reports, we provide quality documentation to
support your validation effort. These deliverables include:
Functional Requirements Document
Design Description (or Specification)
Installation Qualification Protocol (IQ)
Operation Qualification Protocol (OQ)
Performance Qualification Protocol (PQ)
Traceability Matrix
Deviation Logs and Report
Summary and Final Reports
Retrospective Validation
So its a dinosaur! We can help you with that too. Retrospective
validation ensures that your existing systems are brought up to spec
with the current FDA requirements and guidelines.
Revalidation
My system is already validated. Why do I need to revalidate my system?
Once your system is validated, it now goes under strict change control
procedures. Every change made to the system needs to be tested and
documented. Revalidation must occur when the product characteristics
have changed significantly.
Validation Experience
We have been involved in large and small-scale projects for many leading
pharmaceutical companies. Such validation projects include:
Laboratory Information Management Systems (LIMS)
Sales Force Automation
Equipment Validation
Sample Accountability Systems
Data Acquisition and Processing
And much more
Our expertise lies in many areas. We have over 10
years of regulatory and validation experience.
risk-based approach
streamlining without compromise
computer system validation
21 CFR Part 11
full system development
life cycle documentation
regulatory compliance consulting
compliance audits
strong project management
extensive industry experience with major
players
compliance training
> What's New?
Learn more about FDA's
5 major initiatives, including
Efficient Risk Management.
Also get more information
on FDA's Vision 2006.
