Download Guidelines for Validation &Qualification, including Change Control

Links to other
Quality System
Processes.
Procurement:
These links may be shown diagrammatically.
Validation is usually focussed on validating operational processes
and systems and qualifying the facilities, equipment and materials
used in the process or by the system. Clearly the facilities, equipment
and materials are usually supplied by third parties.
Therefore:
 The laboratory quality system should control the procurement and
supply of quality critical goods and services.
 This should include the qualification of suppliers and possibly
trials or evaluation of equipment or materials prior to purchase.
 It is also possible that an important part of the qualification of new
facilities, equipment etc. known as Design Qualification and will
relate to the Functional Design Specification (See Section 7), is
performed as part of the procurement process.
Clearly, the outcomes from this activity will influence subsequent
validation before these goods and services are put into use and
therefore, this section of the VMP should describe, or refer to, the
supplier control procedures.
Training &
Document
Control:
Development of SOPs and training in the use of these SOPs for
operating any new system will be crucial before it is finally approved
for use. This requirement will normally be included in the PQ protocol.
Once the laboratory process, equipment, facilities or systems has
been approved for use, it is essential that documentation is
maintained in a current state. Therefore, part of maintaining
processes and systems in a valid state is the qualification of
operational staff and of SOPs used.
As these are usually described in separate training and document
control procedures they should simply be referenced in this section.
It would be appropriate to describe or reference any staff proficiency
schemes operated by the laboratory in this section.
Facilities &
Equipment
management:
The management and control of facilities and equipment is critical to
maintaining the valid state. In particular servicing, calibration of
instrumentation and re-qualification should be planned and managed
within the laboratory quality system.
These arrangements may be described in this section or reference
made to the appropriate procedures.
Automated test systems may be subject to proficiency or EQA
Schemes and these should be mentioned here.
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