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With the increasing movement of the industry into advanced project philosophies,
such as Risk-Based Approaches to Commissioning and Qualification and Integrated Commissioning and Qualification,
new challenges present themselves to project teams that are attempting
to adopt the best methodologies while maintaining project commitments and goals.
VALSPEC offers a unique set of Quality Governance Services that serve to ensure just that for our clients.
VALSPEC Quality Governance Services tie together all of the important aspects of a project so that Quality is built into the processes and methodologies, resulting in:
Our Quality Governance Team provides the following services to ensure that these results are achieved:
VALSPEC is a Life Sciences industry leader in the application of Risk-Based
approaches to Commissioning and Qualification activities.
VALSPEC specializes in the development of approaches that align testing practices and documentation with levels of risk in terms of patient safety, process criticality, project dynamics, and computer system technologies. These approaches are developed in partnership with client project teams and with the client quality representatives as appropriate. The VALSPEC Risk Analysis program incorporates experience from:
The results of the Risk Analysis are incorporated
into the appropriate Commissioning and Qualification Plans. The results
often include a Test Matrix which documents all required testing steps
for each component of the system (Instrumentation, Process Control
System hardware, network infrastructure and application software) and
maps those testing requirements against the appropriate project phase
(FAT, Commissioning, Qualification). This Test Matrix will dictate what
level of testing will be performed and documented during which project
phase based on the risks identified.
As part of a Risk-Based approach in collaboration with its customers, VALSPEC regularly leads the development and implementation of Integrated Commissioning and Qualification (ICQ), resulting in:
Digitally enabled ICQ leverages attributes of digital
technology to further reduce non value-added C&Q project execution
work practice activities through the use of:
VALSPEC directly employs dozens of trained engineers and consultants
who have expertise in various computer-based systems and all regulatory
requirements and guidelines. We have the expertise to fully commission
and validate your system.
Deliverables may include, but are not limited to:
Valspec possesses unparalleled DeltaV Validation Experience
Since 2001, Valspec has provided over 200,000 service hours supporting
the commissioning and qualification (C&Q) of DeltaV Systems in greenfield
facility and facility expansion projects. Valspec is a North American
and Asia Pacific Alliance Partner with Emerson Process Management. Valspec has executed over 60+ DeltaV validation projects and has been a critical element of the startup or turnaround of major manufacturing systems (>3000 I/O) for clients such as Centocor, Wyeth, Merck, GlaxoSmithKline, Lonza Biologics, and Baxter Healthcare as well as driving the pilot scale and facility expansion projects (<3000 I/O) for clients including Eisai, PharmEco, Apotex, Xcellerex, and Sigma-Aldrich. DeltaV System Knowledge Valspec engineers possess in-depth control system network, hardware and software engineering experience, and are factory-certified in DeltaV Implementation and DeltaV Batch Control. Valspec’s detailed DeltaV architecture knowledge allows the full utilization of DeltaV modularity in developing the most efficient approach to testing strategies and master validation planning. Valspec maintains an in-house DeltaV Testing Laboratory allowing project Simulation Testing capabilities. DeltaV Validation Standards
DeltaV Commissioning and Qualification Innovation
Implementing or upgrading a GxP compliant system on time and within
budget requires experienced project management. For large-scale
systems, project management is the essential component for success.
VALSPEC project managers have the experience and expertise to manage all phases of a project. This includes organizing key personnel, system lifecycle planning, implementation, testing, and release. 
With the frequently changing advisories and guidelines from the
FDA, along with pressures on the cost of compliance and maintaining
quality, it is essential to implement risk-based approaches to compliance
throughout a project and during the lifecycle of a system. Additionally,
life science companies must continually adapt existing and new standard
operating procedures (SOPs) and training programs to ensure quality
standards.
VALSPEC has the experience and expertise to evaluate and improve methodologies used during a project and in the system lifecycle. The result is a more efficient system implementation that ensures product safety and regulatory compliance. This is accomplished by assessing existing procedures and processes, organizational structure and dynamics, and the use of innovative tools to reduce costs and optimize resources. The result is that business, compliance, and quality goals are achieved. Deliverables may include, but are not limited to:
Systems
Automated manufacturing and process control systems must be validated
to be in compliance with current GxP and FDA regulations.Our consultants provide qualification and full system lifecycle management of instrumentation and automation systems including bus instruments, process control systems, custom automation applications, and various ancillary systems that communicate serially or via OPC and other protocols. Our Automation Systems Group combines:
Our consultants have experience and expertise with a wide variety of automated systems,
including but not limited to:
Laboratory systems generate, process, and manage information which
is the basis for product release and regulatory approval decisions.
As a result, laboratory instrumentation, information systems,
and equipment used in both manufacturing and development are often
a focus of compliance inspections.Our consultants provide qualification and full system lifecycle management of laboratory systems including stand-alone automated instruments, networked data acquisition/instrument systems, and laboratory information management systems (LIMS). Our Laboratory Systems Group combines:
Our consultants have experience and expertise with a wide variety of laboratory systems,
including but not limited to:
Data Information Systems are absolute necessities within life sciences companies.
They are used to track and manage their products, as well as manage and secure
data needed for regulatory submissions. These systems must be
validated to be compliant with FDA regulations.Our consultants have experience and expertise with a wide variety of information systems, including but not limited to:
Industries
Pharmaceutical companies continue to face challenges in many aspects of their businesses,
including a diminished pipeline of new products, pressure to reduce
manufacturing costs of existing products, and increased scrutiny
by the FDA. Pharmaceutical companies are looking to be more cost
efficient, maintain or increase product quality, and ensure compliance
to current GxP and FDA regulations.
Biotechnology companies have produced a large pipeline of product applications. These companies
face challenges above and beyond other Pharmaceutical companies,
including more complex and costly manufacturing systems, higher
scrutiny on product quality, and increased focus by the FDA. Biotechnology
companies are looking for efficiencies within their complex systems,
ensuring product quality and strict adherence to FDA regulations.
Medical Device companies are challenged to create advanced technologies in a short
period of time. Additionally, the process of manufacturing medical
devices (including methods, facilities, and controls) must adhere
to high quality standards and be compliant to FDA regulations. Medical
Device companies are looking for efficiencies that will ensure product
quality and strict adherence to FDA regulations .
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Enabling our clients to ensure the quality of their systems
through well-established methodologies, which simultaneously achieve
business and compliance goals.
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