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Updated by Sparta Systems on Apr 09, 2015
Headline for Quality Management Software Solutions for Highly Regulated Industries
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Quality Management Software Solutions for Highly Regulated Industries

For highly regulated industries such as biotech, pharmaceuticals, consumer products, electronic manufacturing, and chemical; producing products that are safe and effective are key. Quality management software applications allow these highly regulated industries to keep their products safe for their consumers and adhere to the highest industry standards. Here is a list of these solutions.


Audit Management

Audit management software enables manufacturers to use the best methods for compliance and risk management. It supports all internal auditing programs and aids auditors in executing efficient compliance audits. It simplifies the auditing process, automating all steps in the auditing lifecycle. These include:

  • Scheduling
  • Preparation
  • Auditing
  • Report approval
  • Report issuance

Compliance Management

Compliance management software ensures that organizations are meeting requirements for a particular regulation. It evaluates risks and potential costs of non-compliance with project expenses to obtain compliance. It promotes a collaborative workspace with communication between departments.


Supplier Quality Management

Supplier quality management software provides efficient control for an organization's supply chain. It features:

  • Supplier scorecards
  • Supplier qualification workflows
  • Tracking systems
  • Supplier audits

Additionally, it tracks and manages the qualification and approval process for new potential suppliers.


Corrective and Preventive Action (CAPA)

CAPA software maintains CAPA plan execution, and streamlines its effectiveness over time. Additionally, CAPA software enables compliance with industry regulations (ISO 9001, TSCA), configure CAPA process workflows, and reduce operation costs.


Change Control

Change control software allows organizations to manage their changes efficiently. It automates the process; organizing tasks such as:

  • Actions required to make changes
  • Regulatory approvals
  • Updates
  • CAPA and product registration tracking