972020 ‘An Overview to User Requirement Specifeations and Design Qualification =
AUGUST 1, 2017 BY COMPLIANCE. TEAM
An Overview to User
Requirement Specifications
and Design Qualification
An Overview to:
User Requirement
Specifications and
Design Qualification
User Requirement Specifications
(URS) and Design Qualification
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‘An Overview to User Requirement Specifeations and Design Qualieaon ~
(DQ) are implemented in many
organizations in response to EU
and other guidance documents.
Many organizations lack
understanding of why these tools
are recommended and therefore
implement them incorrectly or at
inappropriate times.
URS and DQ are tools that were co-opted by the concept of Quality by Design
(QbD). The concept of QbD is driven by ICH Q8 through Q11 as well as Risk Based
Approach models described in ISPE and other baseline guidance documents. A
URS and/or DQ can be used to demonstrate your equipment, instrument, utility
system, process, etc. are following a risk based approach and QbD
User Requirement Specifications
“Ugh, why did they design it this way?" "How am I supposed to qualify this?” These
questions and frustrations are examples of what drove developers of the risk
based approach and QbD processes to start pushing the use of URSs. URSs have
been around for years and many are used to document anything from general
purchase specifications to construction specifications. The main purpose of a URS
is to give a vendor a set of requirements that must be satisfied upon purchase or
receipt of an engineered system. Those involved in generating and maintaining
quality systems within organizations began to realize a URS can be used to
implement quality at the very beginning of the process.
For any organization in a cGMP industry, a URS should be used for one main
purpose: implementing QbD. To achieve QbD, a prerequisite is understanding
what quality is with respect to the equipment or system qualified. The starting
point for a URS is a risk assessment or impact assessment. The assessments
should identify all currently known risks and critical-to-quality attributes and/or
process parameters (CQAs / CPPs). With risks identified, it is possible to also
_ww.compliancoteamine comloverviow-sersoquirement-specifications-design-quaifcation! 216972020
‘an Overview to User Requitement Speciiatons and Design Quatiieaton-
identify methods for risk control and anything necessary to monitor or control
CQAs and CPPs into the URS. The result is a document that drives what testing is
necessary, based on which attributes are truly critical for commissioning and
qualification activities.
The risk assessment is also a starting point (from a quality perspective) for what to
look for in a design specification, functional specification, software design
specification, etc. (Hey, this looks familiar; like we're starting a trace matrix)!) That
is correct; the starting document for a trace matrix is the URS! The critical-to-
quality items identified in the assessments are documented in the URS, and then
included in the design and all subsequent specifications and qualifications,
In the above example, the main purpose of a URS was to demonstrate QbD, but
there are other legitimate reasons for using a URS. Although the not essential for
quality, the URS can capture items such as safety requirements and ergonomic
requirements. These items are important, and if they are excluded from the
purchase specification it makes sense to include them in a URS. When including
non-quality attributes in a URS, it becomes important to specify which
specifications are critical-to-quality and which ones are not, Add a column to a URS
table such as “CTQ (Yes / No)" to make this distinction.
In previous paragraphs, the term engineered system was underlined. Many
organizations erroneously require that all systems on site require a URS. This is a
mistake and demonstrates a poor understanding of the purpose of a URS. In light
of using a URS for QbD it does not make sense to generate a URS for a piece of
equipment or an instrument purchased from a catalogue or off-the-shelf. Itis
difficult to design quality into something that is not being designed. The
appropriate approach for off-the-shelf equipment is to employ a risk or impact
assessment in lieu of a URS. Another approach is to use a general purchase policy
to identify requirements for items such as laboratory instrument. Such a policy
might include Part 11 requirements, purchased qualification packages and/or
specific FDA requirements.
Design Qualification
Where does design qualification fit in? The DQ has a similar purpose as the URS:
to verify CTQ design elements are successfully incorporated into the design. Since
regulatory guidance documents drive use of the URS and DQ, it is important that
URS and DQ documents reflect and focus on critical-to-quality items an auditor
ww compliancoteamine comloverviow-sersoquirement-specifications-design-quaifcation! a6972020
‘an Overview to User Requitement Speciiatons and Design Quatiieaton-
would look for such as quality items that impact patient safety. While important to
document or verify that operator safety, ergonomic and other concerns were
included in the design, segregation should be made between CTQ, and non-CTQ
requirements.
The DQ should be no more complicated than to verify that CTQ items in the URS
successfully made it into the final design. Anything more may be above and
beyond the intent of QbD.
Retrospection
Many organizations decided to retrospectively generate URSs for equipment and
systems that are already in place or which are already designed and built to “check
the box" on the regulatory requirement. Retrospectively generating a URS signals
to an auditor that QbD was accidental and that the organization has not fulfilled
the intent of QbD. Retrospection is non-value-added, so if a project is already past
design/build, it makes more sense to perform risk and impact assessments. This is
a check on commissioning and qualification documentation to verify each CTQ
item, Policies and procedures that allow risk and impact assessments for existing
systems and URS and DQ at the beginning of a new project saves time and stays
true to the intent of a DQ and URS.
Conclusion
The main take away is that the main purpose of a URS and DQ is to ensure and
demonstrate your organization is following QbD for engineered systems. The
starting point for the URS is risk and impact assessments. Without assessments,
the specifications are not targeted to the specific intended use, and may result in
generic engineering specifications that already exist. Quality auditors are the
audience for your quality documents. Auditors want to see a true understanding
of QbD and QbD implemented from start to finish. Call CTI if you or your
organization needs help with identifying where URS and DQ fit into your quality
program or your projects.
Filed Under: Compliance, Featured, Quality by Design, User Requirement Specifications
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