Alternatives to RegDoc eSafe

Interfacing’s Integrated Management System (IMS ) is an AI-supported platform that brings BPM, QMS, Document Control, and GRC together in one environment. Teams use IMS to design and manage processes, govern documentation, oversee risks, and demonstrate compliance with complete visibility and reliable audit evidence. Built for sectors that depend on strict oversight, such as aerospace, life sciences, public sector, and financial services, IMS offers real-time monitoring, automated workflows, and AI-driven analytics that strengthen quality and lower operational exposure. The system is ISO 27001 certified and validated for 21 CFR Part 11, ensuring secure and compliant use in regulated operations. IMS also provides low-code automation, process mining, audit tools, training management, CAPA workflows, and dashboards that help organizations improve performance and maintain regulatory control. AI enhances governance, improves precision, and supports continuous compliance.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

UnForm is a powerful enterprise document management and process automation solution that seamlessly integrates with any application. Our platform-independent, fully browser-based solutions provide the ability to create, deliver, capture, index, route, and store documents from start to finish so that a transaction’s entire life cycle can be accessed with one easy search. Our data extraction and workflow capabilities enable the automation of data entry-intensive processes. UnForm.Cloud, a hosting service for UnForm Document Management, is a perfect fit for those who are running cloud-based ERP systems or looking for a solution with no hardware to purchase, manage, or maintain. Implementing UnForm has never been easier. Backed by a proven hosting vendor, Oracle, you have the peace of mind knowing your data is safe and secure with well-managed data centers and cross-region backups, ensuring reliable and continues access to your data when you need it.

PinPoint DMS makes it possible for you and your staff access files and data anywhere in the world. PinPoint DMS runs on all platforms, including MACs and mobile devices. It includes built-in tools such as Workflow Management, Records Management and Onboarding. PinPoint DMS can automatically file documents without the need for human intervention. PinPoint DMS has been improving our features for over 19 years. We are just now seeing competitors. Learn how our document management software could help your company go paperless!

TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases. Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

Intellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features.

Medrio's Electronic Data Capture (EDC) platform and complimenting eClinical solutions such as ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have been trusted by major pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic companies since 2005. We are known for our easy-to-use solutions, delivering speed and simplicity to clinical trials of all phases, sizes, and complexities. Medrio users can build their databases in an average of 2.8 weeks with no programming required, make mid-study changes with just a few clicks of a mouse, and much more. From bolt-on capabilities to full-service offerings, Medrio offers flexible, modular solutions that give our customers exactly what they need – and none of what they don’t. Our innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.

ProofEasy offers an optimal solution for ensuring document integrity, suitable for organizations across various sectors such as legal, real estate, finance, and banking. This platform allows users to securely send and receive documents without the need for complicated enterprise software, effectively combating document fraud. The innovative use of real-time QR code scanning provides a reliable method for verifying documents, as users can simply scan the code with any scanner, like Google Lens, to access the original uploaded document. This feature enables users to confirm the authenticity of their copies against the source document. By enhancing the transparency and security of electronic and scanned documents—ranging from certificates to financial reports—ProofEasy prevents any tampering. Moreover, it alleviates the need for third-party verification by establishing a secure reference point for verification on a blockchain-based system, ensuring that all documents remain immutable and trustworthy while simplifying the verification process for users. In this way, organizations can focus on their core activities without the constant worry of document fraud.

Streamline your document workflows to eliminate inefficiencies that consume valuable time and resources, hindering your growth and ability to secure new studies. Florence eBinders seamlessly connects all your clinical trial systems, automates eRegulatory tasks, shortens contract negotiation duration, monitors study advancement, and facilitates secure remote oversight on a leading eRegulatory, eISF, and eSource platform. With our highly-rated implementation and support teams, your team and study can be set up quickly, ensuring a smooth transition for all users. Most sites become fully operational within just four weeks! By enabling secure access for your monitors and providing remote capabilities for your team, you can significantly decrease the time spent on-site during monitoring visits. Additionally, this approach fosters a more efficient and flexible research environment.

Experience the forefront of eSource, CTMS, and eRegulatory software designed specifically for clinical trial sites. With CRIO’s top-tier electronic source, you can effortlessly capture source data in real-time, drastically cutting down on paper usage by up to 90% while enhancing data quality by 80%. Gain command over your operations through CRIO’s user-friendly Clinical Trial Management System, allowing you to efficiently schedule patients, monitor financials, and optimize recruiting processes. We proudly present cutting-edge electronic regulatory binders, including the innovative first-ever electronic delegation log, all compliant with 21 CFR Part 11 standards. For clinical trial sponsors, you can perform 100% remote monitoring of your sites’ source data and regulatory documents through a secure online portal. Become a part of our extensive network of over 500 clinical research sites worldwide. Our commitment is to facilitate the growth of your business by streamlining your site’s operations, ensuring that your studies can continue smoothly, regardless of whether you're on-site or not. This way, you can focus on what truly matters: advancing your clinical research initiatives.

Document management, workflow, and portal solution with integrations to accountants and tax professionals. Doc.It Suite software helps tax and accounting firms stay organized by streamlining digital processes and automating them. This increases efficiency, workflows, and profitability and minimizes risk when dealing with financial documents.

SimpleTrials is a subscription-driven, on-demand Clinical Trial Management System (CTMS) tailored for sponsors, Contract Research Organizations (CROs), and research sites. It encompasses a wide array of tools designed to efficiently plan, oversee, and monitor clinical study portfolios, featuring capabilities such as site initiation and subject monitoring, document management through an integrated electronic Trial Master File (eTMF), real-time analytics for studies, comprehensive calendars and monitoring options, customizable fields and trackers, on-demand reporting, planning milestones, management of site contracts and payments, as well as electronic visit documentation. The platform is built to ensure compliance with 21 CFR Part 11 and establishes a secure, validated space for handling clinical trial data. Users benefit from the ability to personalize tracking views, connect with various Electronic Data Capture (EDC) systems, and access pre-built templates for uniform document management. Furthermore, the system enhances collaboration among stakeholders, facilitating smoother communication throughout the trial process.

QR Mark is an innovative solution that uses QR Codes to authenticate and validate documents. It combats document theft by ensuring that every document can be validated using a QR Code, confirming its integrity and authenticity. Each document is assigned a unique QR Code that, when scanned by the user, will direct them to a secure portal displaying all of its original details. This prevents forgery or unauthorized changes. Here are some key features: 1. The recipient can authenticate documents with no restrictions using unlimited verification. 2. Custom branding allows you use your own logo and domain for a personalized experience. 3. Bulk verification allows for the processing of multiple documents at one time. 4. Multi-user access allows for secure team collaboration through role-based permissions. 5. Microsoft 365, Google Apps and APIs are supported for seamless integration. 6. Single Sign-On simplifies secure access to your company's authentication systems.

Enhance the quality of data management by directly capturing eSource data during patient interactions. This process incorporates integrated editing and validation mechanisms, allowing users to electronically gather high-quality information, which significantly minimizes errors and inquiries, while facilitating real-time remote oversight. By doing so, the study duration, expenses, and risks are significantly reduced. FDA-endorsed, this innovative eSource approach simplifies and modernizes clinical trials, effectively replacing slow, error-prone monitoring and the transcription process into electronic data capture (EDC) systems. Additionally, tailored for site users, ez-SourceDocx optimizes workflows, alleviates workloads, and ensures adherence to study protocols by guiding sites through properly sequenced visit procedures, which not only confirm the collection of all endpoint data but also encourage timely quality assessments by investigators. Ultimately, this comprehensive system enhances overall clinical trial efficiency and reliability.

Cloudbyz CTMS is a cloud-based trial management platform natively built on Salesforce Cloud. It is aimed at sponsors, clinical research organizations (CRO), and clinical sites for managing end-to-end clinical trial operations. Designed for clinical research, it expedites implementation and drives user adoption. Cloudbyz CTMS comes with an intuitive, straightforward design that allows for quick deployment. Boasting a rich set of features, Cloudbyz CTMS makes it easy for users to manage all aspects of clinical trials, including sites, enrolment, documents, events, milestones, site visit reports, finances, inventory, etc. The solution benefits are listed below- 1. Secure, reliable & scalable 2. Faster time to value 3. Monitor study progress & risks from planning to close-out 4. Seamless collaboration among sponsors, CROs & sites 5. Improved clinical team efficiency

A scalable, real-time, collaborative, out-of-the box solution for CROs, Life Science Consultants and Industry Stakeholders. Built in an Audit Ready Compliant Cloud environment (ARCC). All 21 CFR Part 11 requirements are met. GxP audit ready. Pre-configured Departmental. Communications with internal and external stakeholder. Secure data integration between remote teams. Collaboration in review and approval. Turn access on/off according to need (EX: auditors), reducing audit prep time from days to hours. Preconfigured to eTMF Reference models & EDM. Intelligent content management tools can improve workflows. Improve document management with real-time collaboration, automatic indexing and co-authoring. Pre-configured, validated system that manages documents and data electronically in accordance with eCTD mandates.

Enhance the efficiency of regulatory operations within your organization to bolster compliance and facilitate research advancements. Veeva SiteVault simplifies the process of managing clinical trials by integrating your regulatory tasks, leading to improved effectiveness and adherence to regulations. You can oversee regulatory and source documents through a unified platform that complies with 21 CFR Part 11 and HIPAA standards. With real-time insights across all trials, SiteVault Enterprise boosts operational effectiveness, accelerates study initiation, and fosters swift, high-quality trial management. Transition away from manual workflows and customize your own processes to enhance both quality and speed in study activation. By granting monitors secure, direct access to your regulatory and source documents, you eliminate the hassles of EMR access and document redaction. Furthermore, you can tailor your workflows, generate reports, and create dashboards to gain deeper insights into start-up timelines and regulatory workflows, ultimately driving better outcomes for your clinical trials. This comprehensive approach not only streamlines processes but also enhances collaboration across teams.

The integration of applications across a wide range of input and output channels is facilitated through open interfaces, adopting an "API First" approach. High efficiency is maintained even when handling extensive document volumes by continually optimizing communication processes. The platform allows for extensibility with the incorporation of NodeJS and NPM packages, as well as well-documented, web-based APIs and customizable process modules tailored to client needs. This adaptability enables clients to model their document control processes according to parameters they define, ensuring that the operations align with their specific business rules. Our dedicated professional services team will collaborate closely with you to achieve these tailored solutions. Additionally, all configured (partial) processes are accessible as web services, enabling integration with third-party applications. DocBridge® Gear serves as a versatile platform that allows for the straightforward configuration of all document creation, conversion, modification, and output processes, independent of any predetermined page format and based on raw data inputs. Furthermore, standard quality assurance procedures, including document checks, comparisons, validations, and release workflows, can also be effectively modeled to enhance operational efficiency. This level of customization and support empowers businesses to optimize their document management strategies comprehensively.

Vault QualityDocs enhances quality processes and mitigates compliance risks through automated workflows and thorough audit trails. By streamlining review and approval procedures, it ensures efficient sharing of SOPs and other GxP documents among staff and collaborators. The automation of workflows, coupled with real-time visibility into content status, empowers organizations to manage SOPs effectively, further minimizing compliance risks. Its user-friendly interface promotes higher adoption rates and operational efficiency. In addition, the system provides detailed audit trails, organized content, and robust search capabilities that greatly improve audit preparedness and inspections. Users can securely access and interact with documents via any major web browser, and if configured, can print, distribute, and monitor controlled PDF copies. The incorporation of predefined document taxonomies, metadata, and selection lists for quality, manufacturing, and validation documents not only streamlines operations but also enables organizations to swiftly embrace industry best practices, ensuring continuous improvement and compliance alignment. Thus, Vault QualityDocs stands as a pivotal tool in modern quality management.

Digitize a variety of media, including documents, images, videos, and more, enabling the collection of nearly any format. Streamline document management from a centralized repository that offers customizable access and security features. By minimizing the proliferation of document duplicates across various systems, you can enhance both accuracy and version control. Encourage seamless document sharing throughout the organization to boost overall efficiency and productivity. Retrieve your files whenever and wherever you need them, using any device at your disposal. Benefit from integrated security measures, including granular controls, encryption, and various authentication methods. Conduct rapid searches of historical records with intricate queries to quickly locate the information you require. Manage everything from paper scans to digital files and video in one cohesive platform. Assign user access and document permissions based on tailored roles, ensuring a secure and efficient workflow. Whether for a single department or an entire enterprise, experience reliable performance in high-volume environments, ensuring that your document management needs are met effectively. This holistic approach not only secures your data but also enhances collaboration across teams.

An accurate assessment of solar energy potential is essential during the pre-feasibility stage of a project. In addition to needing reliable results, it is also important for the pre-feasibility analysis to be conducted efficiently. Tools like Solargis's iMaps and pvPlanner enable quick access to dependable solar yield estimates. The latest Prospect tool enhances the precision of these estimates and facilitates smoother collaboration during the solar project development process. Among the various solar databases, Solargis data is recognized for its superior accuracy and reliability, as supported by multiple independent studies. This data has been validated across more than 1000 locations worldwide, with validation statistics for over 180 non-confidential sites available on the validation map. While popular simulation software such as PVsyst offers sophisticated functionalities for system design and energy modeling, it is important to note that the default weather data provided in these tools may lack reliability. Therefore, utilizing validated solar data is key to optimizing project outcomes.

ClinEdge is revolutionizing the clinical trial landscape by offering a robust array of services designed specifically for Sponsors, CROs, and Sites. By employing creative and collaborative problem-solving techniques, we address the challenges and obstacles our clients encounter. Our commitment to enhancing trial success spans every phase of each study, ensuring that Sponsors and CROs have optimal Site and Patient Access while providing Site partners with improved Trial Solutions. With more than ten years of industry experience and a profound insight into our clients' needs, ClinEdge is dedicated to transforming the way studies are conducted, paving the way for more efficient and effective clinical trials. Through innovation and dedication, we aim to set new standards in the clinical trial sector.

Longboat is a cloud-based solution designed to support clinical trials, offering an integrated Guided Compliance toolset that assists users consistently throughout the process. By supplying clinical trial site personnel with essential resources, Longboat enables them to concentrate on patient care. Additionally, it allows participants to access vital study details and receive reminders for upcoming visits. The platform facilitates the streamlined management of any amendments to the clinical trial protocol, ensuring a smooth and controlled rollout. Furthermore, it centralizes the secure sharing of regulated documents among sponsors, CROs, and sites, which significantly enhances the startup process and simplifies traditionally labor-intensive tasks for all research stakeholders. Through a unified support platform, all key participants—including clinical operations teams, monitors, site personnel, and trial participants—can access customized content that addresses their individual requirements. This comprehensive approach ensures that site staff are equipped with the necessary tools and resources to remain engaged and compliant while prioritizing the needs of participants. In doing so, Longboat not only improves operational efficiency but also elevates the overall experience for everyone involved in the clinical trial.

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

The integration of eCOA and digital technologies is paving the way for the future of clinical research, seamlessly connecting traditional methods with innovative, patient-centered approaches. Choose YPrime's eCOA solutions to not only obtain high-quality patient data but also to enhance the overall user experience for sponsors, investigator sites, and patients alike. By employing a flexible software development strategy, YPrime is able to swiftly tailor and adapt functionalities to meet specific study requirements within an impressive timeframe of 8 to 12 weeks. Our engaging and visual design process allows clients to review the system at various stages of development, ensuring they are informed before the system goes live. Additionally, our pre-validated and customizable authoring environment not only streamlines startup timelines but also accommodates post-production adjustments, such as changes to study protocols, making it an indispensable asset for clinical research. This commitment to agility and responsiveness positions YPrime as a leader in the evolving landscape of clinical trials.

LiveFile360, our enterprise document management system, is fully integrated with enVisual CRM360. Your files are linked to enVisual entities (individuals/companies/trusts etc.) You can also use metadata to simplify your search. LiveFile360 offers fast, secure search that works across any global cloud network.

Heretto is the ultimate AI-powered content operations platform for customer-driven companies. Empower users to resolve product issues independently with our end-to-end cloud-based CCMS, Deploy API, and Portal. Create, manage, and distribute personalized documentation seamlessly for exceptional content experiences.

CB Dynamics 365 SharePoint Permissions Replicator closes the security gap and protects your documents by an automatic synchronization between Dynamics 365 privileges and SharePoint permissions. This is the only solution available on the market that does this. Fully automated, ensure safety and security for all Dynamics 365 / CRM documents. There are no more risks of data loss, reputational risk or GDPR violations. Our solution replicates D365 permission schema, and ensures that SharePoint folders conform to your CRM security model. CB Replicator monitors privileges for D365 data items and synchronizes these modifications to respective SharePoint items - instantly and automatically. It works well with SharePoint Structure Creator and the CB D365 Seamless Attachment Extractor.

eDeviation provides comprehensive tools for assessing and managing Protocol Deviations. It streamlines processes from software design and validation to gathering necessary documentation and exporting information for the Trial Master File (TMF), thereby alleviating the burden on clinical teams who may face risks from improperly assessed or overlooked protocol deviations, whether they occur once or multiple times. As a component of Ethical's eClinical Software Platforms, eDeviation® enhances the efficiency and accuracy of clinical trial management. Whether evaluations are conducted by a dedicated independent committee or by your own research team, our software can be tailored to meet your specific requirements. The integration of forms, workflows, and export functions ensures adherence to GxP standards and fosters effective study management. Additionally, this platform allows study teams, investigators’ sites, and committee members to collaborate online in real-time, facilitating quicker decision-making, reaching consensus, and ensuring the prompt handling of protocol deviation assessments and management. Ultimately, eDeviation® enhances the overall integrity and efficiency of clinical trial processes, contributing to better outcomes in research.

Document management and teamwork are streamlined with myClin, which serves as an interactive and dynamic eTMF solution. You can swiftly upload and share research documents through your secure and centralized myClin channels, facilitating immediate access that speeds up the distribution of essential study updates and training information. With oversight built into the process, our "File it" feature allows you to monitor who has reviewed and comprehended your study materials. This feature not only serves as a record of effective study execution but also tracks training activities such as views, filings, or downloads at both the team and individual levels. Always be prepared for inspections, as our compliance score highlights the engagement levels of each site or study team member with relevant study information. This proactive approach directs you to areas of lower compliance within your study, fostering ongoing improvements in risk management practices. In just a few hours, we can set up a myClin channel for you to explore myClin with your team, making the process exceptionally straightforward. Experience the ease and efficiency that myClin brings to your study management today.

Adept Software provides speedy and centralized access to essential documents within a secure and collaborative setting, helping your business save time, minimize risk, and reduce operational expenses. By aligning your organization on a unified platform, you create a single source of truth that presents a cohesive view of both engineering and business materials. Stakeholders can effortlessly locate the appropriate document from any location, boosting productivity by 20 to 30%. To prevent costly errors and safety concerns, it’s crucial that your team consistently accesses the most accurate version of documents. Efficiency is enhanced, and workflow interruptions are eliminated as documents seamlessly adhere to established approval processes. Timely notifications and alerts ensure that tasks remain on schedule. Design reviews and collaboration across multiple sites become straightforward when everyone operates from the same platform. Additionally, document vaults can be duplicated to ensure local accessibility, while Adept maintains synchronization across all versions. This comprehensive approach ultimately fosters a more connected and efficient work environment for all users.

An electronic signature that holds legal weight offers a secure, trustworthy, and convenient method for your business to send, approve, and sign digital documents. By streamlining your document processes, you can eliminate the need for paper entirely. Simply upload your PDF or .docx file and input the email addresses of the individuals who need to sign. Each signatory will receive a personalized link to provide their signature, ensuring a fully digital experience. This service can be accessed effortlessly from a computer, smartphone, or tablet, making it both user-friendly and efficient. Once the signing is complete, the document is safely encrypted within your account, allowing you to choose whether to save or export it as needed. There's no need for a digital certificate; just sign and proceed. This solution is suitable for various applications including commercial contracts, loan agreements, account openings, general documentation, insurance proposals, and school enrollments. Additionally, you can seamlessly integrate the electronic signature feature into your existing systems through Clicksign's REST API, which helps automate your signature workflows, enhancing productivity further. Embrace the future of document management and streamline your operations today.

Management of clinical data. Comprehensive solution for managing clinical trial information. Easy data entry and creation of CRFs. Support for multi-center complex studies. Data validation and processing is accelerated Multilingual capabilities. Global deployment, cloud-based and on-premise. Clinical researchers understand the importance of reducing time and costs when conducting clinical trials. This is especially true when it comes to the collection, processing, and management of study-specific data. To ensure that the necessary patient data was recorded and sent to the sponsor for analysis and processing, study coordinators used paper Case Report Forms (CRFs). The days of paper CRFs are long gone. The industry now understands that electronic data capture (EDC), systems increase efficiency and improve data quality.

Artificial intelligence influences your company's key performance indicators by enhancing decision-making processes, boosting revenue, and elevating customer satisfaction levels. The AI solutions offered by OrNsoft have a proven history of enabling clients to reach peak performance. CEErtia represents state-of-the-art software that integrates artificial intelligence and cognitive technology for smart process automation. Given the high costs associated with manual labor, CEErtia can significantly lower your expenses while maximizing productivity. Accelerate your operations with CEErtia’s AI capabilities, leading to a substantial decrease in your workload. The software automatically detects and prevents errors, duplicates, and fraudulent activities, ensuring that your documentation remains compliant. Furthermore, you can manage and verify documents from any location, as everything is available online. Our software excels at swiftly verifying and validating data, regardless of its source, making it an invaluable tool for modern businesses. Embracing this technology allows organizations to focus on strategic tasks while leaving routine processes in the capable hands of AI.

Overseeing a stability study involves a myriad of complexities, often leading to potential errors. Relying on a traditional paper-based approach heightens the chances of inaccuracies. To mitigate these risks, it is essential to adopt a software-driven system that streamlines stability studies and shelf-life evaluations. Given that stability studies face intense scrutiny from regulatory bodies, organizations must demonstrate the integrity of their findings. Automated solutions not only enhance efficiency but also generate essential documentation in real-time, addressing the needs of auditors. Tools like Nova-Stability empower companies to uphold regulatory standards while minimizing risks to consumer safety. Nova-Stability is an advanced, feature-rich platform that oversees the complete stability testing workflow. This all-encompassing solution adheres to the latest regulatory requirements on a global scale. Furthermore, Nova-Stability is versatile enough to support various types of stability studies, ensuring comprehensive management across different projects.

KRYSTAL Document Management System, a completely web browser based Document Management System Software Solution, is provided by Primeleaf Consulting Private Limited, an Indian Company based out of Mumbai, India. It is an award-winning Document Management Software Solution from Primeleaf Consulting, Mumbai, India. It is easy to install, easy to configure and easy to use system that allows you to spend more time on customer facing activities – instead of on tedious administrative and paper-based chores.

Organizations face the ongoing challenge of keeping pace with and leading in digital transformation efforts. To achieve this, they require solutions that integrate intelligence into their workflows, particularly in areas like document control and print management, which ultimately drive business success, reduce expenses, and positively influence profitability. Tungsten Output Manager provides a robust governance framework for document control and print management, ensuring organizations can operate efficiently. Its advanced security features enhance document protection, reduce inefficiencies, and address compliance challenges effectively. With its top-tier print and document control functionalities, Tungsten Output Manager streamlines processes through intelligent redaction and efficient re-routing, thereby boosting workforce productivity. Additionally, it safeguards printed materials and prevents the unauthorized dissemination of sensitive data, reinforcing an organization’s commitment to security and efficiency. By implementing such comprehensive solutions, organizations can not only enhance their operational capabilities but also gain a significant competitive advantage in the marketplace.

Clindata Cloud gathers pre-clinical, clinical, and Risk Metric data from various sources and provides the clinical operations teams with data sets that are ready for submission, along with analytics and alerts for risk-based monitoring. It integrates and harmonizes study data from different origins into a unified data model, ensuring that the incoming data is validated for factors such as completeness, accuracy, integrity, and consistency while also raising alerts for any anomalies or risk indicators. Data is standardized according to CDISC data standards to reduce noise and facilitate the creation of ready-to-submit data sets in real-time, allowing for ongoing validation and analysis. Additionally, it produces real-time analytics based on the standardized data, ensuring timely insights for clinical decision-making. This comprehensive approach enhances the efficiency and reliability of clinical operations.

In today's world, numerous nations mandate that businesses and organizations deliver UA-compliant accessible documents to their clientele. NAGIX, a sophisticated document solution by Consist, is designed to automatically and effectively convert large quantities of documents into fully accessible PDFs that adhere to stringent regulations protecting the rights of visually impaired individuals. These documents can include everything from customer forms and financial statements of publicly-listed companies to public protocols from government entities and municipalities. The effective technology behind NAGIX is trusted by major banks and various organizations. Consist, a global software solution provider since 1972, boasts extensive expertise in rolling out advanced system solutions. NAGIX employs an innovative and powerful automatic accessibility technology, allowing visually impaired customers to instantly create accessible versions of any document they require. This capability not only enhances independence for users but also supports organizations in fulfilling their accessibility obligations.

LifeSphere EDC offers a budget-friendly solution for sponsors and CROs to efficiently gather, manage, and report clinical trial data, regardless of the trial's stage or complexity. By consolidating various systems into one cohesive database, it eliminates the necessity for expensive integrations and data reconciliation processes. The platform captures clinical information directly from study sites, thereby removing the reliance on paper Case Report Forms (CRFs) and manual data entry. This approach not only shortens study development timelines but also facilitates smooth implementation of adjustments in ongoing studies. Integrated with the LifeSphere Clinical cloud platform, which includes LifeSphere eTMF and LifeSphere EDC, it effectively links operations with data oversight. Additionally, the single sign-on feature simplifies access to a comprehensive suite of applications, while its open architecture promotes swift integration with external applications through APIs. This level of efficiency ensures that clinical research can adapt quickly to changing demands and maintain high-quality data standards.

The Qualis document management system offers a secure method for managing documentation while allowing for regulated distribution to end-users. It features a workflow-driven document approval process that includes revision tracking, ensuring that end users always have access to the most current approved document, thereby minimizing the chance of using outdated materials. The workflow can be tailored to specific roles, accommodating various organizational needs, and multiple workflows can be implemented to correspond with different document types. This system not only helps in conserving paper and storage space but also ensures secure storage and easy recovery of documents. By distributing only approved documentation, it significantly lowers the risk of circulating outdated copies. Additionally, it enhances regulatory compliance by providing controlled access and facilitating straightforward search capabilities. All metadata is stored in a centralized database, which is flexible and supports various database systems, including MS SQL, Oracle, and Postgre SQL. Overall, Qualis DMS serves as a comprehensive solution for organization-wide document management and regulated distribution, streamlining the entire process for better efficiency and compliance. Ultimately, it establishes a unified platform that integrates all aspects of document management and oversight.

Ensure the security of your documents against unauthorized access while maintaining control over their usage. Streamline processes, enhance efficiency, and foster agility in your operations. Safeguard sensitive customer data from wrongful exposure and offer secure access to essential business applications. Shield your trade secrets and intellectual property from potential threats. Bridge the security gaps inherent in perimeter defenses while facilitating effective collaboration among users. Monitor and protect critical business documents, such as proprietary designs and intellectual assets, across various platforms, including devices, applications, cloud services, and on-premises environments. SkyDRM employs advanced digital rights management and dynamic authorization technologies to safeguard files and facilitate secure sharing practices. The document's protection remains intact regardless of its location or the individuals it is shared with, whether within your organization or externally, on file servers, or in the cloud. You can establish permissions for your files, determining who can access, view, edit, print, or share them, thereby maintaining control over your valuable information. This comprehensive approach not only strengthens your security posture but also empowers your team to work more effectively.

inSight offers an all-encompassing suite of applications tailored to equip researchers with precise and prompt information. The wound assessment and documentation process is enhanced through single image capture, which is securely synchronized in an environment that complies with HIPAA, GDPR, and 21 CFR Part 11 regulations. This platform aims to create a cohesive integrated research experience. By utilizing emerging data and clinical evidence, researchers can formulate study protocols, imaging charters, and adjudication manuals effectively. The system allows for effortless building and configuration of databases, while also enabling customization of clinical workflows that integrate smoothly with your EDC. A dedicated project manager is assigned to guarantee a timely project kickoff and ongoing maintenance. Elevate the reliability of your clinical study by adhering to the highest quality standards and implementing robust quality assurance and control procedures. Users can analyze data and extract insights in real-time, facilitating the curation of data sets and enhancing clinical studies with real-world evidence. Our advanced wound imaging solution is CE-marked and registered with the FDA, having undergone clinical validation to ensure its effectiveness and compliance. With such rigorous standards, inSight stands out as a trusted partner in clinical research.