Pharmaceutical QMS Software

Pharmaceutical QMS software streamlines quality management, helping ensure safety, efficiency, and compliance for pharmaceutical companies.

Comprehensive QMS Software for the Pharmaceutical Industry

Pharmaceutical QMS software is a digital QMS solution designed to manage and optimize quality processes in pharmaceutical manufacturing, supporting regulatory compliance and product quality.

SimplerQMS offers comprehensive pharmaceutical QMS software. The QMS software solution improves workflows and compliance efforts by providing all QMS modules, such as document control, change management, training management, deviation management, CAPA management, and more.

The QMS software is fully validated according to ISPE GAMP 5 and supports compliance with QMS requirements relevant to pharmaceutical companies, such as ISO 9001:2015, GMP, FDA 21 CFR Part 210 and 211, ICH Q10, PIC/S, among others.

Pharmaceutical Quality Management System Software Modules

Explore the QMS modules within SimplerQMS pharmaceutical QMS software.

Quality Event Management

Centralize and control documents and records with version control, e-signatures, and audit trails.

Document Control

Centralize and control documents and records with version control, e-signatures, and audit trails.

Change Management

Streamline change control processes from request submission through review, approval, and implementation.

Training Management

Streamline change control processes from request submission through review, approval, and implementation.

OOS Management

Capture, investigate, and document out-of-specification results to support timely resolution and compliance.

Deviation Management

Record, investigate, and document deviations to support timely resolution and compliance.

CAPA Management

Identify and address quality issues, implement corrective and preventive actions, and reduce recurrence risk.

Complaint Management

Log and manage customer complaints to support investigation, traceability, and reporting requirements.

Audit Management

Plan, conduct, and document audits to support inspection readiness and timely follow-up.

Risk Management

Identify, assess, and document risks to support mitigation and protect quality and compliance.

Streamlines Processes

Optimize quality processes efficiency and minimize bottlenecks by automating repetitive tasks and utilizing predefined workflows.

SimplerQMS offers features that can be seamlessly integrated into your processes, improving efficiency and effectiveness across tasks and projects.

Microsoft Office Integration

Work with Microsoft Office suite applications like Word, Excel, and PowerPoint.

Visual Workflows

Visualize workflows for a complete overview of document processing and related steps.

Actions, Tasks, Reminders

Assign and manage actions with multiple options, relating them to documents, processes, equipment, suppliers, or other items.

File Storage & Sharing

Manage your entire company document repository with secure, centralized storage and easy-access features.

Project Management

Create and oversee processes and projects, linking them to documents, suppliers, and investigation reports.

Group Assignments

Delegate assignments with options to assign review and approval responsibilities to groups or individuals.

Ensures Compliance and Control

Ensure regulatory compliance and operational oversight with predefined workflows. Change control capabilities safeguard against risks, and having all QMS processes integrated improves quality throughout the product lifecycle.

SimplerQMS supports compliance with the relevant pharmaceutical QMS requirements, such as ICH Q10, GxP, ISO 9001:2015, FDA 21 CFR Part 11 and 211, and others.

Life Science QMS Template

Simplify quality management with compliant QMS templates for manuals, procedures, forms, and instructions.

User Access Management

Ensure secure access for both internal and external users while upholding system integrity.

Electronic Signatures

Adopt a paperless signing process utilizing electronic signatures to ensure authenticity and integrity.

System Audit Trail

Maintain a time-stamped audit trail of all system changes in compliance with relevant requirements.

Controlled Printing

Control and monitor document printing to ensure compliance with regulatory requirements.

Reg. Standard Management

Facilitate regulatory compliance with a comprehensive view of regulatory requirements and document relations.

Simplifies Reporting and Information Management

Utilize quality KPI reporting and information management tools to make informed decisions.

SimplerQMS provides quality KPI tracking, streamlined content search, and seamless data export, enabling a data-driven approach to quality management.

Quality KPIs

Make data-driven decisions by monitoring essential quality metrics through quality KPI reporting.

Content Search & Indexing

Quickly locate necessary information with Google-like search capabilities, navigating through all content.

Export Data & Content

Export documents and system metadata easily for analysis or integration with external tools.

Helps Adapt Workflows to Support Specific Processes

Customize your quality management processes with adaptable and comprehensive QMS software.

SimplerQMS enables the creation of personalized fields, forms, and templates for data capture, along with API and system integrations for data synchronization with external tools.

Custom Fields

Customize data capture by configuring tailored fields, including dropdowns, text, numbers, and dates.

Template Management

Create and manage forms and templates for consistent and compliant collection of information.

API / System Integrations

Enable data flow between your QMS and external systems through an API or other system integrations.

Service Components by SimplerQMS

SimplerQMS provides the following service components in addition to all QMS modules and benefits without any extra cost.

Unlimited Online Training

Have unlimited online training to equip users with comprehensive knowledge and skills, ensuring proficient system utilization.

System Implementation

Benefit from professional system implementation support, facilitating an efficient transition to the QMS software and minimizing disruptions.

Document Migration

SimplerQMS assists customers in migrating documents to the system, ensuring data integrity and continuity while saving time and effort.

Audit Assistance

Benefit from audit assistance regarding quality management software, supporting system validation, data security, and data backup.

System Validation

Have a fully validated system according to ISPE GAMP 5 in a perpetually validated state with each new version or standard update.

Cloud Hosting

Benefit from cloud hosting’s accessibility, offering secure, reliable eQMS access anytime, anywhere, without extensive IT infrastructure.

QMS Software With Transparent Pricing for Budget Control

SimplerQMS offers a comprehensive QMS software solution including all QMS modules, system validation, implementation, cloud hosting, user training, and support – all incorporated within the yearly license cost.

The total cost varies depending on the quantity and type of licenses acquired. There are no additional costs.

What Customers in the Pharmaceutical and Biotechnology Industries Say

“User-friendly and simple to use. Easy to customize to fit your individual needs. The modular system ensures that users can only see relevant modules.”
Michael T.
Director Quality, Pharmaceuticals
“Exceptional customer service, excellent “hands-on” training, and they are willing to help my team integrate other applications with SimplerQMS. They have been true partners in implementing SimplerQMS.”
John O.
Sr. Director of Quality, Biotechnology
“Simple system that was incredibly easy to set up. It comes pre-validated, which, in turn, saves the company a lot of time and effort. Great customer support.”
Mads D.
Head of Quality Assurance, Pharmaceuticals

Dedicated Support That Always Has Your Back

Online Training Sessions

Receive comprehensive training, and ensure you and your team are proficient in using the QMS software.

24/7 Customer Support

Our expert team is always available to promptly address your queries and provide assistance.

Knowledge Base

Access our knowledge base for articles and step-by-step guides to support your self-learning process.

Frequently Asked Questions

What is Pharmaceutical QMS Software?

Pharmaceutical Quality Management System (QMS) software is a tool that helps pharmaceutical companies manage their QMS processes more efficiently while ensuring compliance.

Pharma QMS software includes features and capabilities necessary to streamline and automate QMS processes, such as document management, change control, training management, CAPA management, customer complaint management, and audit management, among others.

Why Do Pharma Companies Use QMS Software?

Pharmaceutical companies use QMS software for several reasons, as listed below.

• Regulatory Compliance: QMS software helps pharmaceutical companies comply with requirements, such as ICH Q10, GxP, ISO 9001:2015, 21 CFR Part 11 and 211, EU Annex 11.
• Process Efficiency: Pharmaceutical QMS software streamlines quality management processes, improving operational efficiency and reducing errors.
• Risk Management: QMS software facilitates risk assessment and management, helping companies identify and mitigate risks.
• Collaboration and Communication: The QMS software fosters collaboration among teams, providing a centralized platform for tracking tasks.
• Continuous Improvement: Pharmaceutical QMS software supports a culture of continuous improvement by facilitating management of quality issues.

Who Can Benefit from Pharmaceutical Quality Management Solution?

Various departments within a pharmaceutical company can benefit from pharmaceutical QMS software:

• Research and Development (R&D): Improved data integrity and compliance.
• Quality Assurance (QA): Ensures product quality and regulatory compliance.
• Manufacturing: Monitors production processes and manages batch records.
• Regulatory Affairs (RA): Complies with national and international regulatory requirements.
• Human Resources (HR): Manages employee training programs and compliance tracking.

What Should I Know When Choosing a Pharmaceutical QMS Software?

Selecting a pharmaceutical QMS software involves several steps:

• Assess Requirements: Determine necessary functionalities.
• Research and Compare Vendors: Gather information and compare features.
• Request Demos and Meetings: Evaluate suitability through demos.
• Consider Trial Period: Test functionality and usability.
• Make Final Decision: Choose the most suitable solution based on all gathered information.

What is the Best QMS Software for the Pharmaceutical Industry?

The best QMS software varies depending on each company’s specific needs and requirements. SimplerQMS is chosen by many for its comprehensive capabilities tailored to Life Science needs.

What Makes SimplerQMS Different Compared to Other QMS Solutions?

SimplerQMS stands out for several reasons:

• Microsoft Office 365 Integration: Collaborate effortlessly with existing applications.
• Full Validation: Complies with relevant regulations and standards.
• Unlimited 24/7 Support: Expert customer support with no extra charges.
• Enterprise-Grade Infrastructure: Ensures reliability and compliance.

How Long Does It Take to Implement SimplerQMS?

SimplerQMS is generally deployed within 5 to 6 weeks, depending on document migration and resource availability.

How Much Does SimplerQMS Quality Management Software Cost?

Pricing starts at $17,500 or €15,500 per year for approximately 10 users, covering all features and services.