Standard Operating Procedure
Title: Impact Assessment for Computerised Systems
An illustration of the structure of a Computerised System is the following Finishing Line PLC:
Master Packing Line PLC SCADA interface for Line
Item Monitoring.
Operator Panel
Packing Line PLC (internal) Functions:-
Servo Drives Various
1. Control line operation i.e., pad
printing.
Vision System 2. Monitor quality functions, i.e.,
Vision system, Leak testers,
Inspection.
Printers
3. Track rejects and eject using shift
System Related
register.
Boundary Items
Inkjet Printer
4. Calculate reject statistics.
5. Detect alarm conditions.
Leak Testers
3. Criticality Assessment (Quality Impact)
Validation is concerned with assuring that our manufacturing processes, activities and systems
deliver product that reliably meets quality standards. Product Quality attributes are Identity, Safety,
Efficacy, Purity, and Evidence. Examples of quality characteristics are shown in the table in Section
10. Consideration of the significance of electronically records generated may influence the Criticality
Assessment, as outlined in Section 11.
3.1. Direct Impact
Impact Assessments look individually at the Items within Computerised Systems to evaluate the
affect of their Functions on product quality.
The following list of questions assess whether an Item/Function has a “Direct Impact” on the quality
of a product/process or integrity of stored data.
(If the answer to any question is “YES” the Item/Function has Direct Impact.)
The Criteria below should be used to assist in formulating a judgement based on the
comprehensive understanding of the product, process and the nature of the system. They
should NOT be used to replace the exercise of professional judgment by appropriately
qualified personnel.
1. Is the Item used to demonstrate compliance with the registered process?
2. Will the normal operation or control by the Item have a direct effect on the product/process
quality, (including ingredients and product components)?
3. Will failure of the Item or its alarms have a direct effect on product quality or efficacy?
4. Is information from this Item recorded as part of batch record, lot release data, or other GMP
related documentation?
5. Does the Item control critical process functions that may affect product quality (and there is
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Standard Operating Procedure
Title: Impact Assessment for Computerised Systems
to lower levels should be assessed on the basis of their GAMP rating however their
interaction with higher levels within the Item must also be considered.
Note that the Data level has no GAMP rating. If this level however, has a GMP role it may
determine the overall Impact of the system (i.e. Direct). Examples of ratings for various
types of records are shown in Section 11. Data layers with GMP Impact require control
measures to preserve their documentation attributes (i.e. accuracy, authenticity, availability
and integrity). These control measures should be recorded on the Impact Assessment form
and included in the Validation Plan.
5. Overall Risk-Profile Classification
Combine the Impact rating and GAMP category to determine a Validation strategy (C number):
Impact Assessment (Criticality)
No Impact Indirect Impact Direct Impact
on GXP Functions on GXP Functions on GXP Functions
No impact on the Items that may affect the Items that have a direct
performance or performance or operation of effect on the
operation of GxP other Items which have performance or
GAMP Category Functions Direct Impact on GxP operation of GxP
(Complexity) Functions Functions
C1 C1 C1
1. Operating
systems Validation: Validation: Validation:
Record Version & Record Version & GEP Record Version & GEP
GEP Functional Functional Functional
C1 C1 C2 Validation:
2. Firmware
(Instruments Validation: Validation:
and controllers) Record Version & Record Version & GEP Record Configuration
GEP Functional Functional and Version No & GEP
Functional
C1 C2 Validation: C3 Validation:
3. Standard
packages Validation:
Record Version & Record Configuration and Minimal Functional
GEP Functional Version No & GEP
Functional
4. Configurable
packages C2 Validation: C3 Validation: C4 Validation:
Record Configuration Minimal Functional Some Functional
and Version No &
GEP Functional Minimal Structural
5. Custom-built
C3 Validation: C4 Validation: C5 Validation:
Minimal Functional Some Functional Extensive
Minimal Structural Functional
Extensive Structural
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Standard Operating Procedure
Title: Impact Assessment for Computerised Systems
the site can be reduced. Tests recorded on protocols developed by suppliers do not require
copying to site formats (so long as the content is appropriate). Conversely, where there is
reason to be concerned about the assurance provided by a supplier, additional testing and
input by the site may be necessary. For maximum benefit, any extra involvement from the
site should be provided as early as possible within the Development Lifecycle.
Other Compliance Requirements. Where assurance of software performance is required for
other reasons (e.g. compliance with EHS regulations) additional testing might be
considered. Such testing may utilise the formats and structures of Validation protocols, as
appropriate.
8. Qualification
As shown in Figure 6.1, the overall qualification of the Computerised System would be comprised of
the activities of validation corresponding to the categories of the individual Items, once the criticality
and the complexity of the Items are established (refer to section 5.0).
8.1. Good Engineering Practices
All systems, regardless of their Quality Impact, are to be supplied and developed in
accordance with Good Engineering Practices (GEP). For many systems there will be no
separate requirement for Validation and GEP alone is sufficient. Evidence of GEP includes:
Developments are designed or specified against agreed requirements
Competent personnel (including contractors) are selected for the task
Full consideration is given to EHS, Operating, Maintenance and Standards requirements
Completed works are inspected, tested, commissioned and recorded appropriately.
The “GEP-alone” approach does not imply an absence of documentation; rather there is a
reduced need for review and approval of this documentation by Quality Assurance
personnel.
8.2. Structural Verification
Structural verification involves inspection and assessment of the actual source code by a
suitably qualified person (who is not the programmer). Documentation used to support
verification include logic diagrams, description of modules, definitions of all variables and
specification of all inputs and outputs. Structural verification is used to assess:
1. General application of good programming standards and practices. Some programming
practices are known to be associated with operational failures, or to hamper ongoing
maintenance. Depending on the software being programmed, the following are
examples of issues that might be verified:
code layout is logical and the flow is easy to follow, including adequate comments that
aid understanding by others who may need to maintain it in the future,
dead code and open-loops have been removed or commented out,
variables are sensibly named,
confounding special values are excluded e.g. divide by zero or square root of a negative
number,
operations with invalid or missing data are prevented (e.g. by checking for empty strings,
correct data type, values within limited range),
parameters are initialised to a known value prior to use to prevent unexpected results,
the program operates safely when abnormal (error) conditions occur,
invalid, illegal or adverse conditions such as alarms, alerts, errors and hardware failures,
are identified and highlighted to the user in a way that allows appropriate response,
databases and fields are correctly indexed,
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