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Product Management

Optimize product management with centralized document handling and automated workflows for data traceability in life sciences.

Solution by SimplerQMS A/S
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Overview

The Product Management Solution for Life Sciences enables the optimization of product management workflows, ensuring efficient handling of documentation from conception to market launch. This solution is integrated into an all-in-one eQMS, allowing for streamlined management of products and related documents within a single system.

The software offers a centralized approach to product documentation management, facilitating automated workflows and enhancing document traceability. Users can relate products to various system items such as documents, equipment, suppliers, and audits, and capture specific product data using custom fields.

Centralize Product Information

This solution acts as a single source of truth, centralizing all product-related information, including specifications and documentation. It promotes cross-departmental collaboration and minimizes errors by ensuring consistent, accurate information, maintaining compliance across the organization.

Scalable Storage Capacity

The cloud-based system allows users to scale the storage of up to 150,000 documents, accommodating growing product portfolios. Storage capacity increases automatically with additional user licenses, and products can be organized using customized views to enhance workflow and accessibility.

Control Changes and Ensure Integrity

Product integrity is protected through Change Control processes that prevent unauthorized modifications. Change requests and actions are tracked, ensuring no new risks are introduced, and maintaining a clear audit trail for product development.

Flexible Product Data Management

Personalize product item lot numbers and relate product data within the system. Flexible options support traceability and inventory management, while cross-departmental collaboration is facilitated through linked product information.

  • Relate products to documents, batch master records, and more to streamline regulatory submissions.
  • Create document collections for streamlined review and approval processes.

Customizable Data Fields

Use custom fields to capture detailed and specific information about products, such as sterilization data and shelf life. Customize fields with lists, numbers, dates, and text to meet unique product information requirements.

System Integration

Integrate the SimplerQMS with existing systems, including PLM, ERP, CRM, and LMS, using an open API and plugins. Tailor integrations to specific needs, ensuring flexibility and connectivity.

By linking relevant files to chosen products, the system supports compliance and facilitates thorough product documentation handling.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & ComplianceCollaboration & Knowledge
Target user(s)
QA / Regulatory AffairsLab Manager / Core Facility Manager