Pharmaceutical QMS Software

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

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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.

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Document Control

Keep your documents audit-ready while managing a high volume of data accurately.

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Training Management

Develop employee competence while maintaining compliance. Streamline the training process with learning rules and training groups, automate task assignments, reminders, and more.

Change Control icon

Change Management

Streamline change control processes from change request submission to final approval and successful implementation.

Deviation Management Icon

Deviation Management

Enhance investigation, documentation, and resolution of deviations through a streamlined deviation management process.

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CAPA Management

Enhance your corrective and preventive actions to enforce continuous improvement and resolve issues as they arise.

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Complaint Management

Streamline your complaint management workflow and turn complaints into product improvement opportunities and increase customer satisfaction.

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OOS Management

Streamline your out-of-specification (OOS) laboratory result investigations by ensuring consistent OOS result intake, root cause identification, follow-ups, and resolutions.

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Audit Management

Reduce the time and effort needed to pass audits successfully by streamlining audit-related activities.

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Risk Management

Consolidate and organize risk management documentation throughout all quality processes.

Equipment Management Icon

Equipment Management

Simplify the equipment registration, calibration, and maintenance tasks with straightforward workflows.

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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.

Ongoing Task Completion

Related features

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.

Computer and Electronic Signature

Related features

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.

Reporting - Bar Chart

Related features

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.

Workflow Configuration

Related features

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

Life Science Quality ManagemenHave unlimited online training to equip users with comprehensive knowledge and skills, ensuring proficient system utilization.t Software

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

Life Science QualHave 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.

Everything you need is covered. It is that simple.

All QMS Modules

System Validation

Document Migration

Cloud Hosting

Implementation

User Training

Unlimited Support

And much more…

What Customers in the Pharmaceutical and Biotechnology Industries Say

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“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

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.

QMS software supports all QMS processes, helping companies achieve and maintain compliance with requirements set by regulatory authorities such as the FDA and EMA.

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, and more. QMS software helps ensure that products meet quality and safety requirements set by regulatory authorities.
  • Process Efficiency: Pharmaceutical QMS software streamlines quality management processes, such as document control, change management, training management, deviation management, and audit management. QMS software improves operational efficiency and reduces errors.
  • Risk Management: QMS software facilitates risk assessment and management. QMS software helps pharmaceutical companies identify and mitigate risks associated with product quality, safety, and compliance.
  • Collaboration and Communication: The QMS software fosters collaboration and communication among cross-functional teams. The QMS software provides a centralized platform for sharing information, tracking tasks, and documenting quality-related activities.
  • Continuous Improvement: Pharmaceutical QMS software supports a culture of continuous improvement by facilitating the management of quality issues. QMS software simplifies tracking corrective and preventive actions and monitoring key performance indicators (KPIs) to drive ongoing process improvement.

Various departments within a pharmaceutical company can benefit from pharmaceutical QMS software, as listed below.

  • Research and Development (R&D): R&D teams benefit from pharmaceutical eQMS through improved data integrity, traceability, and regulatory compliance. R&D scientists, lab technicians, and project managers leverage eQMS software to manage complex data and documentation.
  • Quality Assurance (QA): Quality Assurance departments utilize QMS solutions to ensure product quality and regulatory compliance. QA specialists rely on the software to manage audits, deviations, CAPAs, and other processes to ensure adherence to applicable requirements.
  • Manufacturing: Manufacturing departments use eQMS software to monitor production processes, manage batch records, and ensure operational efficiency. Production managers, process engineers, and quality control analysts benefit from control of manufacturing processes.
  • Regulatory Affairs (RA): Regulatory Affairs departments depend on pharmaceutical eQMS to ensure compliance with national and international regulatory requirements and customer requirements. Regulatory professionals and compliance officers use the software to manage regulatory submissions and maintain up-to-date compliance documentation.
  • Human Resources (HR): HR departments leverage electronic QMS to manage employee training programs and ensure that all staff are qualified and compliant with regulatory requirements. HR managers and training coordinators use the QMS software to track employee certifications and manage training schedules, and competency assessments.

Selecting a pharmaceutical QMS software involves several steps to ensure it meets the company’s needs. The steps companies can follow to choose QMS software are mentioned below.

  • Assess Requirements: Determine regulatory compliance needs and necessary QMS software functionalities.
  • Research and Compare Vendors: Gather information from vendors through Requests for Information (RFI), Requests for Quotation (RFQ), and Requests for Proposal (RFP), comparing features and various aspects.
  • Select Relevant Vendors: Choose vendors aligned with company needs, considering reputation and customer reviews.
  • Request Demos and Meetings: Evaluate QMS software suitability through demos and meetings with shortlisted vendors.
  • Consider Trial Period: Test QMS software functionality, usability, and compatibility with existing workflows during the system trial period.
  • Shortlist Vendors: Narrow options and create a shortlist based on demos, meetings, and trials.
  • Request Use Case Demonstrations: Ensure QMS software addresses daily operations by requesting use case demonstrations.
  • Negotiate Terms: Discuss pricing, contracts, and implementation with shortlisted eQMS software vendors.
  • Make Final Decision: Consider all information, including demos, trials, and negotiations, to choose the most suitable QMS software solution.

The best QMS software for the pharmaceutical industry varies depending on each company’s specific needs and requirements. Several factors determine the most suitable QMS software for a pharmaceutical company, including the size of the company, regulatory requirements, budget constraints, and specific operational needs.

Some pharmaceutical companies choose SimplerQMS as their preferred QMS software due to its comprehensive capabilities that are tailored to Life Science needs.

SimplerQMS offers integrated QMS modules, including document control, change management, training management, CAPA management, and more.

SimplerQMS is designed to support compliance with a range of requirements, including ISO 9001:2015 and FDA 21 CFR Part 11, 210, 211, and 212, ICH Q10, and GMP, among others.

Moreover, SimplerQMS offers integration options with various systems, such as Customer Relationship Management (CRM), Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), Product Lifecycle Management (PLM), and Manufacturing Execution System (MES), improving its adaptability and utility within pharmaceutical operations.

SimplerQMS stands out from other QMS software solutions for several reasons. The following are 10 reasons that set SimplerQMS apart.

  • Seamless Microsoft Office 365 Integration: Collaborate effortlessly by working in Microsoft Office applications, such as Word, Excel, and PowerPoint, while editing documents in SimplerQMS.
  • Use Your Existing Forms and Documents: In SimplerQMS, you can continue using your forms and templates in the familiar Word and Excel format. We migrate documents and other file types, eliminating the need to rebuild your documentation in SimplerQMS.
  • Full Validation: SimplerQMS is fully validated according to ISPE GAMP 5, complying with FDA 21 CFR Part 11, 211, and 212, EU GMP Annex 11, and Eudralex Volume 4 GMP Part 1. We provide continuously updated validation evidence, including full Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Unlimited 24/7 Support: Enjoy expert customer support around the clock with no extra charges. Reach out via email, phone, video calls, support portal, or online knowledge base, and we’re ready to assist without counting hours.
  • Integrated Life Science QMS Modules: You can access all QMS modules at no extra cost, including document control, change management, training management, CAPA management, and many others.
  • Configurable Metadata and Reporting: Add metadata fields to support best practices and easily report on your data with built-in or customizable views.
  • Expertise in Life Science Processes and Audits: Benefit from our extensive experience in audits and inspections by regulatory authorities. The system complies with the requirements related to QMS in regulations, standards, and guidelines, such as ICH Q10, GxP, FDA 21 CFR Part 11, EU GMP Annex 11, ISO 9001:2015, ISO 13485:2016, and more.
  • No Charge for Onboarding: Our license cost includes all services, including onboarding, implementation, training, validation, hosting, and support. At the yearly license cost, you can access unlimited training supported by videos and recordings, as well as a training environment for testing new implementations before they go live.
  • GxP Enterprise-Grade Infrastructure and Services: Enjoy enterprise-grade infrastructure with Single Sign-On (SSO) across Windows, Mac, and mobile devices through Microsoft Entra ID. Our ISO 27001:2022 and SOC 2/3 compliant Microsoft Azure hosting ensures reliability and compliance.
  • Wide Integration Support: Use our modern API or plugins to seamlessly integrate with other systems, such as ERP, CRM, PLM, LIMS, and more.

The QMS software solution by SimplerQMS is generally deployed within 5 to 6 weeks.

The time needed for QMS software implementation can vary depending on factors such as the number of documents to be created or migrated and the company’s available time resources.

SimplerQMS software implementation follows a structured phase approach, emphasizing the deployment of specific QMS modules. SimplerQMS enables customizable module sequences tailored to individual needs, with all implementation activities and associated training included at no additional cost.

SimplerQMS quality management software pricing starts at $14,500 or €13,500 per year for approximately 10 users. The total cost depends on the types and number of licenses required.

The yearly license cost includes all QMS modules, system implementation, user training, ongoing support, validation, and cloud hosting.

The SimplerQMS pricing structure is based on the number of licenses obtained, and it covers all features and services without extra costs.

Please visit our pricing page for detailed information on costs, features, and services provided.

See SimplerQMS in Action

To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.

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