Exporting Fields with “Hide If” Logic

A set of macros has been added to mergeFields.v m to allow for conditionally exporting those fields in templates. For each of the following tracker names, there's a table that represents:

1. What field will be conditionally hidden
2. The macro that's been defined that executes the conditional logic
3. The field name triggers the conditional showing
4. The value that triggers showing

To add these conditional values inside of a word template, create a MERGEFIELD with the conditionally hidden field and wrap that in a bookmark called if_should_disclaimer. For example:

[ { MERGEFIELD item.disclaimer \* MERGEFORMAT }]

Then, only if the macro if_should_disclaimer is calculated as true, will the field be visible on export. Finally, all conditional fields that depend on the same conditions to hide/show them must be wrapped in the same bookmark.

Design Input

Field Name	Macro	Depends on Field	Depends on Field Value
Predicate Device Reference	if_predicate_device_reference	Design Input Source	Predicate Device
Hazard Categories Reference	if_hazard_categories_reference	Design Input Source	Hazard Categories
VOC Reference	if_voc_reference	Design Input Source	VOC
Standards Reference	if_standards_reference	Design Input Source	Standards
Requirement Decomposition Reference	if_requirement_decomposition_reference	Design Input Source	Requirement Decomposition
Feasibility Reference	if_feasibility_reference	Design Input Source	Feasibility
Surveillance Reference	if_surveillance_reference	Design Input Source	Surveillance
Guidelines Reference	if_guidelines_reference	Design Input Source	Guidelines
Usability/Human Factors Reference	if_usability_human_factors_reference	Design Input Source	Usability/Human Factors
Literature Reference	if_literature_reference	Design Input Source	Literature
Clinical Reference	if_clinical_reference	Design Input Source	Clinical
Regulatory Reference	if_regulatory_reference	Design Input Source	Regulatory
Risk Control Measures Reference	if_risk_control_measures_reference	Design Input Source	Risk Control Measures
Trade Reference	if_trade_reference	Design Input Source	Trade
Legal Reference	if_legal_reference	Design Input Source	Legal
Manufacturing Reference	if_manufacturing_reference	Design Input Source	Manufacturing
Other Reference	if_other_reference	Design Input Source	Other
Associated URL(s)	if_contains_software_firmware	Contains Software/Firmware?	Yes
Other Requirement Category	if_requirement_category_is_other	Requirement Category	Other

Business Input

Field Name	Macro	Depends on Field	Depends on Field Value
Predicate Device Reference	if_predicate_device_reference_bi	Business Input Source	Predicate Device
Hazard Categories Reference	if_hazard_categories_reference_bi	Business Input Source	Hazard Categories
VOC Reference	if_voc_reference_bi	Business Input Source	VOC
Standards Reference	if_standards_reference_bi	Business Input Source	Standards
Requirement Decomposition Reference	if_requirement_decomposition_reference_b	Business Input Source	Requirement Decomposition
Feasibility Reference	if_feasibility_reference_bi	Business Input Source	Feasibility
Surveillance Reference	if_surveillance_reference_bi	Business Input Source	Surveillance
Guidelines Reference	if_guidelines_reference_bi	Business Input Source	Guidelines
Usability/Human Factors Reference	if_usability_human_factors_reference_bi	Business Input Source	Usability/Human Factors
Literature Reference	if_literature_reference_bi	Business Input Source	Literature
Clinical Reference	if_clinical_reference_bi	Business Input Source	Clinical
Regulatory Reference	if_regulatory_reference_bi	Business Input Source	Regulatory
Risk Control Measures Reference	if_risk_control_measures_reference_bi	Business Input Source	Risk Control Measures
Trade Reference	if_trade_reference_bi	Business Input Source	Trade
Legal Reference	if_legal_reference_bi	Business Input Source	Legal
Manufacturing Reference	if_manufacturing_reference_bi	Business Input Source	Manufacturing
Other Reference	if_other_reference_bi	Business Input Source	Other
Associated URL(s)	if_contains_software_firmware_bi	Contains Software/Firmware?	Yes

Verification Test Protocol

Field Name	Macro	Depends on Field	Depends on field Value
If No, provide rationale why parts are representative of final design	if_parts_representative_rationale	Will test be conducted on production parts with all features using all manufacturing processes?	No

Verification Test Steps

Field Name	Macro	Depends on Field	Depends on field Value
Training Disclosure	if_training_disclosure	Is the test protocol author and test executor the same individual?	Yes

Validation

Field Name	Macro	Depends on Field	Depends on field Value
Disclaimer	if_should_disclaimer	Do you want to create the protocol in assisted in Codebeamer?	Yes
Test Methods / Activity	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Acceptance Criteria	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
User Group	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
User Group and Rationale	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Specimen Selection	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Specimen Selection Rationale	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Sample Size Determination	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Sample Size Determination Rationale	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Will test be conducted on production parts with all features using all manufacturing processes?	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Were any observations of use errors or use difficulties made during the Validation?	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
Were there any deviations from the approved protocol such as: test method, sample size, or specimen	if_create_protocol	Do you want to create the protocol in assisted in Codebeamer?	Yes
If No, provide rationale why parts are representative of final design	if_no_test_on_parts	Will test be conducted on production parts with all features using all manufacturing processes?	No
If Yes, provide root cause and discuss impact on risks	if_yes_use_errors_or_difficulties	Were any observations of use errors or use difficulties made during the Validation?	Yes
If Yes, provide rationale why the difference is acceptable	if_yes_deviations	Were there any deviations from the approved protocol such as: test method, sample size, or specimen	Yes
If No, provide action plan	if_not_acceptance_criteria_met	Acceptance Criteria Met	No

Hazard Analysis

Field Name	Macro	Depends on Field	Depends on field Value
Existing Mitigation	if_existing_mitigation	Is there an Existing Mitigation?	Yes
RCM	if_risk_control_measures	Are there new Risk Control Measures?	Yes
Justification of No additional risk control measure	if_no_risk_control_measures	Are there new Risk Control Measures?	No

dFMEA

Field Name	Macro	Depends on Field	Depends on field Value
Risk Control Measure – Mitigation	if_has_risk_control_measures	Does this Failure Mode have Risk Control Measures?	Yes

Packaging Design Validation Protocol (EGP)

Field Name	Macro	Depends on Field	Depends on field Value
6.2.1 Additional Information	if_621_addl_info_needed	6.2.1 Additional Information Needed?	Yes
Samples without Product Size Selection	if_samples_without_product_1	Samples without Product Required?	Yes
6.3 Sample Size and Test Requirements for Samples without Product	if_samples_without_product_1	Samples without Product Required?	Yes
6.3.1 - Sample Size Requirements without Product, Sterilized	if_samples_without_product_1	Samples without Product Required?	Yes
7.1.2 Assembly Requirements for Samples without Product	if_samples_without_product_2	Samples without Product Required?	Yes
7.1.2.1 - Assembly Requirements without Product	if_samples_without_product_2	Samples without Product Required?	Yes
7.4.3 Post-Sterilization Evaluation Instructions without Product	if_samples_without_product_3	Samples without Product Required?	Yes
8.5 Dye Penetration Sample Evaluation	if_dye	Package Integrity Type	Dye
8.5.1 Dye Penetration - Acceptance Criteria	if_dye	Package Integrity Type	Dye
8.5 Leak / Bubble Emission Sample Evaluation	if_bubble	Package Integrity Type	Bubble
8.5.1 Leak / Bubble Emission - Acceptance Criteria	if_bubble	Package Integrity Type	Bubble

Note that the Sample Test Requirements table columns that need to be hidden conditionally will be done so through a calculated field value.

Packaging Design Validation Report (EGR)

The following fields can't be conditionally hidden:

• Table 3B
• Table 3B - Manufacturing Build Summary

Preliminary Hazard Analysis

Field Name	Macro	Depends on Field	Depends on field Value
6.2.1 Additional Information	if_hazard_category_applicable	Is the Hazard Category Applicable	Yes

Sterilization Assessment - EO

Field Name	Macro	Depends on Field	Depends On Field Value/Id
Load Characteristics AMIF Cycle #77 / ISL Cycle #8	if_lc_amif_cycle_77_isl_cycle_8	Initial Validation Report #	1
Load Characteristics AMIF Cycle #14 / SSG Cycle #6	if_lc_amif_cycle_ssg	Initial Validation Report #	2
Load Characteristics Steritec Cycle #4	if_lc_steritec_cycle_4	Initial Validation Report #	3
Load Characteristics ISL Cycle 3.5	if_lc_isl_cycle_3_5	Initial Validation Report #	4
Load Characteristics Steris - RK	if_lc_steris_rk	Initial Validation Report #	5
Load Characteristics ISL Cycle 8	if_lc_isl_cycle_8	Initial Validation Report #	6, 8
Load Characteristics ISL Cycle 8 (INC EO 5)	if_lc_isl_cycle_8_inc_eo_5	Initial Validation Report #	7
Load Characteristics Ciclo BioProd	if_lc_ciclo_bioprod	Initial Validation Report #	9
Load Characteristics Mediplast Cycle #8-TAG, Cycle #9-TAG	if_lc_mediplast_cycle_8_tag_cycle_9_tag	Initial Validation Report #	10
Load Characteristics Cycle SC-01, Cycle SC-02	if_lc_cycle_sc_01_cycle_sc_02	Initial Validation Report #	11
Load Characteristics F4 Cycle	if_lc_f4_cycle	Initial Validation Report #	12
Load Characteristics Cycle B-01, Cycle C-01	if_lc_cycle_b_01_cycle_c_01	Initial Validation Report #	13
Additional Testing Required Discussion	if_additional_testing_required_disc	Is additional testing, justification, or discussion required ?	Yes

User Need

Field Name	Macro	Depends on Field	Depends On Field Value/Id
Other Source of Need	if_source_of_need_is_other	Source of Need	Other