spl-spm

Extensive features including text comparison, data migration, automation, validation and EDMS integration, Freyr SPL-SPM meets the demanding standards of structured product labeling and structure product monograph.

Simplify and automate

SPL-SPM submissions

Structured Product Labeling (SPL) & Structure Product Monograph (SPM) are the mandatory document mark-up standards for Regulatory submission of label content, product and facility information, and any subsequent changes to the existing label information in an electronic format.

Freyr SPL-SPM software is enhanced with extensive features like text comparison, data migration, automation, validation and integration with EDMS. We have introduced both on-cloud and on-premises models to help clients in the reduction of implementation time by providing cost-effective solutions for SPL-SPM submissions.

functional highlights

 

interactive dashboards and reports

 

workflow management

 

strong editor and text comparison

 

central repository

 

data migration and integration with DMS

 

automation and validation

key features

text compare and Up versioning the existing SPLs and SPMs

administration of users, roles, FDA SPL data elements and Health Canada SPM data elements, company, and products information

SPL-SPM and supporting documents repository and SPL-SPM versions management

submission life cycle management

bulk SPL-SPM data migration at the time of client site hosting

reduced manual efforts

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about Freyr SPL-SPM

www.freyrsplspm.com
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