# QMS Software for Contract Research / Manufacturing Organizations (CRO / CMO) Streamline operations and maintain regulatory compliance with purpose-built quality management software for Contract Research / Manufacturing Organizations (CRO / CMO). **Join Over 5,000+ Quality Professionals Who Trust SimplerQMS** ## Ensure Regulatory Compliance in Your Contract Organization Contract manufacturers, clinical research organizations, and testing laboratories (CxOs) must comply with the same regulatory requirements as their clients in the pharmaceutical, biotechnology, medical device, and other life science industries. CxOs must maintain compliance with relevant standards, regulations, and regulatory guidelines in Life Sciences depending on the clients they serve such as GxP, FDA 21 CFR Part 11, 210, 211, and 820, ISO 13485:2016, ICH Q10, EU MDR and IVDR, EU GMP Annex 11, ISO 9001:2015, and others. Compliance with these requirements can be achieved easier and faster with a purposefully built QMS software solution for Contract Organizations from SimplerQMS. ## One Platform That Integrates All Quality Processes With the SimplerQMS software solution, you can streamline regulatory compliance and typical CRO / CMO quality control processes by automating repetitive documentation activities. Integrate all your quality assurance and control processes, store data in centralized, cloud storage, and manage risks, training, audits, suppliers, and other processes with ease. ## Work More Efficiently in Microsoft Office Environment SimplerQMS integrates with native Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint, so you and your team can work with the tools you’re already familiar with. Simply work on your documents within Microsoft Office applications and once the work is done, save them with one click in SimplerQMS Cloud. No manual download and upload of documents are required. ## Streamline Your Document Control Processes Automate document routing, follow-ups, tracking, escalation, review, approval, and other document-based processes. With features like time-stamped audit trails and FDA 21 CFR Part 11 compliant electronic signatures built into the SimplerQMS solution, you can be confident that all documents are processed efficiently and follow the applicable regulatory requirements. ## Forget About Time-Consuming Validation Activities Software validation is a requirement for CROs and CMOs as well as other life science organizations that store and manage quality records electronically. SimplerQMS provides a fully validated solution and performs monthly re-validation of the system, in compliance with FDA 21 CFR Part 11, ISO 13485:2016, and GxP guidelines. This means that your organization won’t have to spend time on system validation processes. ### What Validation Documentation Evidence Does SimplerQMS Provide? - Validation Procedure - Validation Plan - Validation Report - IQ, OQ and PQ Documentation ## Manage Nonconformance More Easily The SimplerQMS nonconformance management solution facilitates the process of identifying, evaluating, analyzing, and managing non-conformances. Access a single source of truth where all processes are connected from non-conformances and other quality events to training, audit findings, and more. ## Resolve Customer Complaints Quickly and Effectively As a CRO / CMO, it’s of the highest importance for you to meet the requirements of your main customers without delays and quickly resolve any complaints. SimplerQMS provides robust customer complaint-handling capabilities which allow you to track, manage, analyze and resolve customer complaints in a timely and effective manner. ## Automate and Gain Traceability of Your CAPA Processes The SimplerQMS CAPA management software solution integrates with different QMS sub-systems and provides a closed-loop CAPA process. Save time with automated CAPA workflows and pre-configured CAPA forms, and avoid any errors in manual data entry or process execution. ## Manage Changes More Effectively The change control module by SimplerQMS allows you to automatically track changes, collect data, and send changes through an approval process. Automated follow-ups, notifications, and escalation activities help you quicker finalize changes to SOPs in your system. ## Expedite Employee Training Management Processes With continuous changes taking place daily, you must ensure that employee training in your contract organization is well-documented and in compliance with regulatory requirements. SimplerQMS training management module streamlines training processes by automating the assignment of training activities, reminders, generation of training certificates, and more. ## All-in-One QMS Software for Life Sciences ### 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. ## Frequently Asked Questions **Why Is Quality Management Important for CROs and CMOs?** As a Contract Research / Manufacturing Organization (CRO / CMO), you are responsible for ensuring that the services you provide meet customer expectations and regulatory requirements. An effective quality management system (QMS) is essential to help you manage your processes and ensure compliance. **What Are the Benefits of QMS Software for CROs and CMOs?** QMS software solutions offer many benefits for Contract Organizations, including streamlined operations and improved efficiencies, reduced paper documentation and associated costs, increased visibility into quality data for better decision making, improved compliance with regulatory requirements, and enhanced communication between sites, sponsors, and staff. **Is SimplerQMS Solution Software Validated?** Yes, SimplerQMS provides a fully validated software solution. It is validated according to ISPE GAMP5 and undergoes revalidation for each new version or standard update. **We do all the software validation for you** – there are no additional expenses, resources, or time commitments to software validation on your part. SimplerQMS complies with requirements regarding the validation of systems used for QMS such as 21 CFR Part 11, and 820, EU GMP Annex 11, and ISO 13485:2016.