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Project and Quality
Management
We manage the three typical project management concerns, of Time,
Cost, Quality in accordance with effective Project/Quality Planning
based on our experience and proven industry guidelines. By working
closely with senior management and project teams to ensure required
deliverables are both planned and managed effectively, we ensure
required quality standards are built in and maintained throughout.
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Vendor Selection &
Procurement
We assist in clarification of requirements for both customers and
vendors and help to ensure that required documentation to
appropriate standards are in place and are understood in order to
ensure the procurement process works in favour of all concerned.
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Supplier or Internal Audits
We offer a wide External Audits, covering the review status of new
or existing suppliers and their adherence to recognized good quality
practices. In addition, we also specialize in conducting all aspects
of Internal Audits that can range from retrospective audits of
existing buildings, departments, sites, systems, processes or
on-going projects covering single or multi-site locations. By
providing effective health status checks to senior management, we
help save both time and money.
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Validation and Quality
Planning
Planning, and more importantly effective planning, is the key to
success. Our consultants help companies and organizations plan the
validation/quality strategy of a system or piece of equipment,
covering roles and responsibilities, deliverables, and policies and
procedures that must be covered.
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Documentation
Management and Support
Our consultants assist in creation and management of documentation
from establishing effective documentation standards, to ensuring
conformance to them, including formal reviews and change management
and approval. By adopting a policy of continuous improvement, our
consultants help companies establish a baseline and solid foundation
that can be built on.
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Test Management and Support
Our consultants assist in all areas of testing throughout the
lifecycle, including guidance procedures, policies and in particular
procedures covering specifications, protocols and their planning and
execution. Management and support of these activities as well as
managing the expectations of both users and senior management are
challenges, which our consultants deal with on a regular basis.
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Configuration Management
Documentation, Hardware and Software are key areas of Configuration
Management that must be dealt with. Our consultants provide
effective advice and support by revising or providing policies and
procedures that can demonstrate compliance to regulatory needs as
well as effective tracking of versions and traceability. Assessments
of equipment and systems for conformance to cGxP regulations
continues to trouble many companies, in particular with systems
containing electronic records and signatures as defined in US FDA 21
CFR Part 11. By utilizing our regulatory database cGARD (current
Global Automated Regulatory Database) our consultants can help to
identify particular areas of concern. By active involvement in many
industry led initiatives, our consultants are at the forefront of
the very latest information available.
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Risk Management
By adopting an industry and regulatory recognized processes of a
risk based approach, our consultants help to ensure that risks are
identified, documented, prioritised and mitigated through a
considered process.
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Data Migration and
Archiving Strategy
Effective planning and documentation by our consultants ensure that
data being moved from one system to another, be this as part of a
system upgrade or retirement, is conducted in an effective and
compliant manner.
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Periodic Reviews
Review of individual systems or complete departments and sites for
current compliance to cGxP regulations ensures that modifications,
changes, status of backups, etc. are all under control and that the
current status of the system is validated and therefore compliant.
Often too many changes can mean that the system is not under
effective control and our consultants identify these areas and help
to implement corrective actions in order to resolve issues in a cost
effective and pragmatic manner.
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Gap
Analysis
Our consultants are well trained to review your business for areas
of non-compliance such as aspects of system implementation, on-going
maintenance and support, in particular the lack of company policies
and\or procedures. With respect to life cycle implementation, the
review of traceability from User Requirements to Functional
Requirements, and traceability and analysis of gaps between the
Functional Specification and the Test Specifications are key and our
consultants assist in providing Traceability Matrix and Risk
Management documents which can support identified gaps so that
appropriate actions can be taken. By working with staff and
management, our consultants can really make the difference and help
a company focus.
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