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.

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.

1. Assess Requirements: Determine regulatory compliance needs and necessary QMS software functionalities.
2. 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.
3. Select Relevant Vendors: Choose vendors aligned with company needs, considering reputation and customer reviews.
4. Request Demos and Meetings: Evaluate QMS software suitability through demos and meetings with shortlisted vendors.
5. Consider Trial Period: Test QMS software functionality, usability, and compatibility with existing workflows during the system trial period.
6. Shortlist Vendors: Narrow options and create a shortlist based on demos, meetings, and trials.
7. Request Use Case Demonstrations: Ensure QMS software addresses daily operations by requesting use case demonstrations.
8. Negotiate Terms: Discuss pricing, contracts, and implementation with shortlisted eQMS software vendors.
9. 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.

1. Seamless Microsoft Office 365 Integration: Collaborate effortlessly by working in Microsoft Office applications, such as Word, Excel, and PowerPoint, while editing documents in SimplerQMS.
2. 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.
3. 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).
4. 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.
5. 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.
6. Configurable Metadata and Reporting: Add metadata fields to support best practices and easily report on your data with built-in or customizable views.
7. 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.
8. 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.
9. 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.
10. 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 $13,750 or €12,500 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.