QualityOne Vaults provide users the ability to analyze single or multi-batch COA (Certificate of Analysis) files. Review the information in Setting Up Inspections and ensure you have set up the prerequisite records before completing this configuration. You must complete the configuration steps in this article for your Vault to use the automated inspection of COA records.
Note: This feature is currently available only to Early Adopters. Contact your Veeva Representative for more details.
About Multilingual Support
QualityOne provides multilingual support for COA Inspection data records. This support helps to display data records localized to a user’s Vault language. Vault displays localized data records by searching for records that match the original data value and the language value is equal to the user’s Vault language.
Example Scenario:
- The Characteristic (original) data value is “Moisture”.
- The user’s Vault language is set to “French”.
- When the user opens the Inspection Sample Test Result record to view the Characteristic value, Vault displays a Localized Characteristic value “Humidité” (Admin-created localized data record).
In this scenario, the existing localized data record for Characteristic specified Vault to display “Humidité” when the data value equals “Moisture” and the user’s language equals “French”. If there is no localized data record set up for the Characteristic “Moisture” in “French”, Vault continues to display “Moisture” as a Characteristic for the French user with an empty Localized Characteristic field.
COA File Language Support
Currently, AWS Textract supports only English, Spanish, Italian, Portuguese, French, and German uploaded COA files. Any language uploaded that is unsupported by Textract may return “blank” or “invalid” records to Vault when running the Analyze COA action. When Textract returns “valid” records, Vault can detect Vault-supported languages from these COA file records and store the detected language. The detected language is used to filter matching rule variants and component matching variants.
Note: Localized data records are not affected by Textract not supporting the user’s Vault language. Any files that contain more than one (1) supported language may return ‘invalid’ records to Vault.
About Multi-Batch File Support
QualityOne also supports COA files that contain multiple related batches within a single COA file. Users can upload or email to Vault to create a COA Inspection record for each related batch and analyze the extracted information from each portion verified in the file. Typically when a user triggers the Analyze COA action for a multi-batch COA file on a COA Inspection record, Vault does the following:
- Verifies the number of batches found in the file. The first batch detected is set to the COA Inspection record where the action is triggered; Vault marks this initial record as the Main Batch record.
- Creates the related COA Inspection batch records for each verified batch found after the first.
- Links each related batch record to the Main Batch record where the action was triggered.
- Analyzes each batch record according to the portion extracted from the multi-batch COA file and creates the Inspection Sample for each batch record (main and related).
- If users trigger the Analyze COA action again, Vault deletes all existing related Inspection Sample records and re-creates new Inspection Sample records according to any new changes.
- Changes the lifecycle state for the Main Batch record to COA Uploaded and sets all related batch records to the same lifecycle state.
Users cannot trigger the Analyze COA action on a related batch record. If users attempt to trigger this action on the related batch record, Vault prompts them to navigate to the Main Batch record to trigger the action from the appropriate record.
When analyzing the file, Vault uses the Header Key to identify each batch in a file and map the extracted information according to the portion found to the appropriate batch record. That extracted information populates the Main Batch record and each related COA Inspection batch record similarly to when Vault ingests and analyzes a single COA file. If the Header Key is unidentifiable, Vault identifies the repetition of a Characteristic or the unique Supplier Manufacturing Lot Codes used in the document to verify the number of batches.
Configuration Overview
Configuring your Vault to use COA Inspection involves the following steps:
- Provide AWS credentials to allow users to use COA
- Set up localized data records to allow multilingual support
- Set up email intake for COA file uploads
- Define variant records for ingestion accuracy
- Configure all COA object layouts
- Configure COA object actions
- Configure user permissions
Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.
Providing Credentials
In order for users to be able to use the automated inspection of COA feature, you must provide AWS credentials in your Vault.
To provide credentials:
- Navigate to Admin > Settings > Application Settings.
- Click Edit.
- In the Inspections Management section, enter your COA AWS Account Id.
- Click Save.
Note: The value for AWS Veeva External Id is a UUID provided by Veeva. Contact your Veeva Representative for more details.
Setting Up Localized Data Records
To display localized data records to provide multilingual support, you need to:
- Set up localized data records linking to the original data records and the language of the translation.
- Update the Inspection Plan Requirement object layout with the Localized Fields.
After you have completed the initial setup and update, users can view the original record and its matching localized data record. You can also use the localized data record to match ingested test result variants against inspection sample test results.
Setting Up Automated COA Email Intake
To allow users, External Collaborators, and external parties to submit COA documents by emailing to Vault, you must set up the Automated COA Email Intake feature. See Setting Up Automated COA Email Intake for more details.
Defining Variant Records for Accurate File Ingestion
Vault relies on diverse variant records to accurately ingest data from COA files for the matching COA Inspection records. You must define the following before users can work with COA files and records:
- Define COA Matching Rule records to guide Vault to the matching extracted analysis results for Inspection Sample Test Results. See Defining COA Matching Rules for more details.
- After defining the required COA Matching Rule records, create COA matching rule variants to define various alternate terms for each matching rule to improve the accuracy of field value ingestion. See Configuring COA Matching Rule Variants for more details.
- After defining the global Characteristics and Units, create COA characteristic and unit matching variants to define various alternate terms and units of measurement to improve the accuracy of field value ingestion. See Configuring COA Component Matching Variants for more details.
- After defining the global Characteristics and Materials, create COA attribute and verdict variants to define various alternate terms to improve the accuracy of field value ingestion. See Configuring COA Attribute Test Result Variants for more details.
Configuring COA Inspections Object Layouts
We recommend updating object layouts for the following objects:
- For the COA Inspection object type of the Inspection (
inspection__v) object:- Detail Form Section: Include the External Collaborator, COA File Uploader, COA Ingestion Status, COA Ingestion Error Type, COA Ingestion Source, COA Ingestion Status Last Modified, and Source Inspection fields for the COA Inspection (
coa_inspection__v) object type. You can modify the Label and optionally provide Help content for users. Without the COA File Uploader field, users cannot upload COA files for analysis. The External Collaborator field allows users to assign an external user for collaboration, such as uploading and analyzing a COA file via email.
- Detail Form Section: Include the External Collaborator, COA File Uploader, COA Ingestion Status, COA Ingestion Error Type, COA Ingestion Source, COA Ingestion Status Last Modified, and Source Inspection fields for the COA Inspection (
- For the Inspection Sample (
inspection_sample__v) object:- Detail Form Section: Include the Pass / Fail? and Pass / Fail Icon fields.
- Related Object Section: Insert the Inspection Sample Test Result (
inspection_sample_test_result__v) object and include the Analysis Source, In Spec?, Test Method, Test Result Units, Test Result (Variable Data), Test Result Variable Data Symbol, Test Result (Attribute Data), Characteristic, CTQ?, LSL, Spec Unit, USL, and In Spec Icon? field columns.
- For the Inspection Sample Test Result (
inspection_sample_test_result__v) object:- Detail Form Section: Include the Target Value (Attribute Data) and Observed Attribute Result fields.
- For the Inspection Plan Requirement (
inspection_plan_requirement__v) object:- Detail Form Section: Include the Target Value (Attribute Data) field and two (2) Localized Field control fields with the slider (
) icon for the Characteristic and Unit objects.
- Detail Form Section: Include the Target Value (Attribute Data) field and two (2) Localized Field control fields with the slider (
- For the COA Matching Rule (
coa_matching_rule__v) object:- Related Object Section: Insert the Component Matching Variant (
component_matching_variant__v) object and include the Variant Text, Variant Type, Expected Value Format, Supplier Name, Supplier Manufacturing Site Name, Material, and Language field columns.
- Related Object Section: Insert the Component Matching Variant (
- For the COA Matching Rule Variant (
coa_matching_rule_variant__v) object:- Detail Form Section: Include the Variant Text, Variant Type, COA Matching Rule, Expected Value Format, Supplier Name, Supplier Manufacturing Site Name, Material, and Language fields.
- For the Component Matching Variant (
component_matching_variant__v) object:- Detail Form Section: Include the Status, Component Matching Variant Type, Characteristic, Unit, Variant Text, Material, Supplier Name, and Supplier Manufacturing Site Name fields.
- For the COA Header OCR Data (
coa_header_ocr_data__v) object:- Related Object Section: Insert the COA Table Column OCR Data (
coa_table_column_ocr_data__v) object.
- Related Object Section: Insert the COA Table Column OCR Data (
- For the COA Test Results OCR Data (
coa_test_results_ocr_data__v) object:- Detail Form Section: Include the Characteristic, Characteristic Score, COA Header OCR Data, Test Method, Test Method Score, Test Result, Test Result Score, UoM, UoM Score, Specification, Specification Score, Min, Min Score, Max, and Max Score fields.
- For the Characteristic (
characteristic__v) object:- Detail Form Section: Include the Characteristic, Status, Description, and Type fields.
- Related Object Section: Insert the Component Matching Variant (
component_matching_variant__v) object and include the Variant Text, Material, Supplier Name, and Supplier Manufacturing Site Name field columns.
- For the Unit (
unit_of_measure__v) object:- Detail Form Section: Include the UoM, Status, Type of Measurement, Unit Description, and Conversion Factor to Base Unit fields.
- Related Object Section: Insert the Component Matching Variant (
component_matching_variant__v) object and include the Variant Text, Material, Supplier Name, and Supplier Manufacturing Site Name field columns.
- For the Material (
material__v) object:- Insert the Control Chart control section with the slider () icon.
- Insert the Control Chart control section with the slider (
Configuring COA Object Actions
The Inspection object lifecycle contains the following actions:
- Analyze COA: Triggers Vault to perform an OCR scan of the uploaded COA file and then compare the measurement values on the COA file with the specified Inspection Plan limits. If triggered on a Main Batch record, all related COA Inspection batch records and their related data records will be re-created (all previous related records will be deleted during this process). You can specify which users can execute the Analyze COA action by configuring Atomic Security for the Execute permission in object lifecycle states that contain the action. Vault creates job logs whenever this action is triggered and updates the following fields:
- Sets the Processed Straight Through? field to “Yes” on the COA Inspection record. The Processed Straight Through? field updates to “No” when you modify a related Inspection Sample Test Result record or create a new Inspection Sample Test Result record for the inspection.
- Updates the Pass/Fail? field value based on the Inspection Sample analysis result.
- Analyze Inspection: Triggers Vault to perform an evaluation using the Pass/Fail? field value against the observed inspection samples to pass or fail the inspection, based on the specified Inspection Plan criteria. Any Inspection Sample with the Exclude from Analysis field values of “No” or blank values are included in the evaluation.
- Download COA OCR Data: Triggers Vault to export OCR data that contains JSON coordinates for Complex matching rules. This action is typically run by Admins only. If your Vault supports multi-batch COA files, this action is available for Main Batch records only.
- Delete Inspection: Triggers Vault to delete the Inspection record and all related child records.
- Send CoA Upload Workflow Task Email: Triggers Vault to send the COA Submission notification to the assigned External Collaborator on the COA Inspection record to upload a COA file for the inspection record.
- Sync Related Records: Triggers Vault to copy specific modified field values in the existing Inspection record and update their related fields in the related Inspection Sample Test Result records to display the new modified values.
- Set COA Analysis Results: Triggers Vault to create or update the COA Analysis Results record with statistical information from an analyzed COA Inspection record. This action typically runs when the COA Inspection record enters a completed lifecycle state.
Depending on your business needs, you can:
- Add these actions as user actions on any Inspection lifecycle state:
- Analyze COA
- Analyze Inspection
- Download COA OCR Data
- Delete Inspection
- Send CoA Upload Workflow Task Email
- Sync Related Records
- Add these actions as entry actions on any Inspection lifecycle state:
- Analyze COA
- Analyze Inspection
- Send CoA Upload Workflow Task Email
- Set COA Analysis Results
Configuring User Permissions
You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:
- You must ensure users have the appropriate permissions to access the required objects, object types, and object fields, as well as be assigned to the appropriate role for COA Documents to be able to analyze COA files.
- To use the Automated COA Email Intake feature, ensure that you define the User Groups for the User Group for COA Email Intake Notification field by navigating to Admin > Settings > Application Settings > Inspections Management. Adding the appropriate user groups allows the defined groups to receive any Vault notification when Vault fails to ingest any COA attachments.
Related Permissions
You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:
| Type | Permission | Controls |
|---|---|---|
| Security Profile | Admin: Configuration: Object Lifecycles: Create, Edit | Ability to create and modify object lifecycles. |
| Security Profile | Admin: Configuration: Object Workflows: Create, Edit | Ability to create and modify object workflows. |
| Security Profile | Admin: Configuration: Objects: Create, Edit | Ability to create and modify Vault objects. |
| Security Profile | Admin: Settings: Application: Edit | Ability to modify the Settings > Application Settings page. |