|
Manufacturing Systems
Compliance
CimQuest, Inc, has long been acknowledged as a
leader in systems regulatory compliance consulting
services in the Manufacturing and Operations areas.
Our expertise has developed over many years of
continued consulting support to FDA- Regulated
companies. Our validation consultants specialize in
the process control and automation engineering
disciplines. They provide assistance with Systems
Validation, Control Systems Technology, Computer
Integrated Manufacturing (CIM) and Manufacturing
Execution Systems (MES) compliance.
Our highly trained consultants are experienced
with a variety of manufacturing automation systems
including: Distributed Control Systems, Flexible
Batch Systems, PLCs, SCADA, MES and Facility /
Utility systems (e.g. Building Management Systems,
HVAC Controls, USP/NF WFI/RO/DI Water Systems).
We have proven templates for many types of
manufacturing equipment qualification, and can
expedite the production and commissioning of your
equipment. We have significant project management
experience with large projects that include DCS and
integrated computerized manufacturing processes.
Whether you need help with conducting a gap
analysis of your entire manufacturing operation,
developing requirements or design documents for a
specific automated process, or developing and
executing validation related documents, CimQuest can
help you at any phase of your project.
Laboratory Systems/Instruments
Compliance
CimQuest, Inc. provides regulatory compliance
consulting services to clients who need assistance
with their laboratory environments. Whether the need
is for validation of laboratory systems (e.g.
Laboratory Information Management Systems (LIMS),
Chromatography Data Acquisition Systems) or
qualification of instruments, CimQuest can provide
skilled, experienced consultants to handle the work.
Many laboratories have discovered that they have
significant exposure relevant to compliance with 21
CFR Part 11, Electronic Records, Electronic
Signatures. Laboratories typically have many
instruments that generate large volumes of data. The
authenticity and reliability of this data must be
assured. We can assist your laboratory by conducting
a compliance assessment of all of your systems, or
help with individual systems or instruments.
Cimquest has many years of proven compliance
consulting experience in all GxP laboratory
environments including QA/QC, R&D, Contract Labs,
and Clinical Testing. This experience means that you
have a trusted partner who understands laboratory
compliance.
Global Business/Supply Chain
Management Systems Compliance
Today's global market demands that companies
operate more efficiently than ever. Instead of
discrete applications that do not communicate
outside their own environment, companies are
implementing global business solutions that address
the needs of the enterprise. CimQuest understands
the business needs of the corporate environment, and
merges their business systems savvy with their
regulatory compliance experience to provide
solutions to the FDA regulated industry. Our
experience includes the leading ERP, MRP and Supply
Chain Management applications, as well as Document
Management, Corporate Quality, and GAPA Systems.
Whether you need proven Project Managers to affect a
compliant business solution, or need a Validation
Master Plan for all of the shared applications,
CimQuest can address your compliance concerns.
IT/IM/Infrastructure and
Systems Compliance
Although software may be qualified for use, the
environment under which it is used must also be
compliant in order to support it in a validated
state of control. CimQuest provides a process model
for implementing an appropriate IT infrastructure
(based on GAMP) for supporting compliant systems and
focuses on applicable regulatory predicate rules and
Good Electronic Records Management practices.
CimQuest understands that a company must be
compliant, but needs to keep their business running
without overly restrictive procedures. We apply a
common sense approach using risk analysis to
determine where detailed procedures are needed, and
where they are not. The IT environment is dynamic;
and traditional qualification and validation
practices are not easily applied. Therefore,
CimQuest helps companies implement a compliant
process to ensure that their infrastructure is
providing services and documentation that their
clients expect. This process is adaptable and
scalable to the size and needs of your company.
CimQuest's process model delivers the following:
- Provides a roadmap to be followed for
implementing compliant IT practices Identifies the
activities, which must be in place to support a
regulated system
- Identifies the deliverables which result after
implementing the infrastructure process
- Standardizes compliance practices across
departments
- Provides an understanding of applicable
regulations that affect the IT activities
Clinical Systems Compliance
The R&D Subject Matter Experts at CimQuest work
synergistically to solve R&D, laboratory, clinical
trial and business system problems in all R&D
operational areas:
- Pathology
- Toxicology
- Drug Metabolism
- Pharmacokinetics Environmental Safety
- Clinical Microbiology
- Analytical Chemistry
- Animal Studies
- Chemical Development
- Pharmaceutical Technologies
- Stability Studies
- Clinical Trials Data Collection
- Clinical Manufacturing
- Clinical Packaging
- Document Management
Although the R&D process can vary from company to
company, the requirements and objectives remain the
same: develop and prepare a product for market.
CimOuest has helped many Clinical R8D environments
with their systems compliance needs, be it in
discovery, pre-clinical or in phased trials. These
environments require specialized clinical trials and
protocol management systems that can provide a
complete package for NDA submission. CimQuest helps
minimize your compliance exposure, and by applying
our many years of experience and understanding of
regulatory expectations, to expedite submission
approval process. |
Part
11 White Paper
