Ratings and Reviews 0 Ratings
Ratings and Reviews 0 Ratings
Alternatives to Consider
-
RegDeskRegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies. • Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates. • With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time. • The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions. • Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners. • The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards. • Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators. To learn more about our offerings, please explore our website.
-
QualioQualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
-
Lockbox LIMSA cloud-based Laboratory Information Management System (LIMS) is designed to oversee sample tracking, test outcomes, and inventory management specifically for life sciences research, industrial quality control laboratories, and biotechnology/next-generation sequencing applications. This comprehensive system provides essential regulatory compliance support for standards such as CLIA, HIPAA, Part 11, and ISO 17025, ensuring that laboratories operate within the necessary legal frameworks. The importance of quality, security, and traceability in managing samples cannot be overstated, as these factors play a pivotal role in a lab's effectiveness and reliability. Utilizing the Lockbox LIMS platform, laboratory professionals gain the ability to meticulously oversee their samples, offering complete transparency throughout the entire process, from initial accession to long-term preservation. Additionally, LIMS analysis encompasses far more than merely tracking outcomes; the Lockbox system features advanced multilayered sample storage capabilities and location management, allowing users to customize their laboratory's storage framework with diverse options that include rooms, storage units, shelves, racks, and boxes. This flexibility empowers labs to efficiently organize and access their samples, ultimately enhancing operational productivity and accuracy.
-
QBenchQBench provides a comprehensive solution for monitoring all your samples and their positions within the workflow through a unified platform. By using QBench, you can forgo the traditional reliance on spreadsheets, shared network folders, and outdated paper tracking systems. The platform enables you to review numerous PDF reports and Certificates of Analysis (COAs) before finalizing or distributing them via email. You also have the option to create customizable barcodes and labels for your samples, ensuring compatibility with standard printers and scanners. Additionally, QBench features a billing module that streamlines the creation and dispatch of invoices directly from the system. Users can access data on counts and latencies for various data types within QBench, which encompasses metrics such as turnaround times, sample counts per test, delays, and more. This innovative tool simplifies the data collection process necessary for the assays conducted in your laboratory while enhancing overall efficiency. With QBench, managing your laboratory workflow has never been more straightforward and effective.
-
Interfacing Integrated Management System (IMS)Interfacing’s IMS is an AI-enabled platform that combines business process modeling, quality management, controlled documentation, and governance/risk capabilities in a single hub. Organizations rely on IMS to document and automate workflows, maintain versioned records, manage risk programs, and keep compliance activities aligned with regulatory requirements through full lifecycle traceability. Developed for industries where accountability and oversight are essential, including aerospace, pharma/biotech, finance, and government, IMS delivers operational insight, workflow automation, and intelligent recommendations that help reduce risk and improve quality outcomes. The platform holds ISO 27001 certification and includes 21 CFR Part 11 validation, supporting secure use in high-compliance environments. Additional capabilities include low-code app creation, AI-based process mining, audit management, CAPA and training modules, and performance dashboards. AI improves governance accuracy, strengthens compliance posture, and supports ongoing improvement.
-
SAP S/4HANA Cloud Public EditionSAP Cloud ERP is the modern, SaaS ERP built for growing mid-market manufacturers, distributors and omni-channel retail that need to replace outdated systems with a clean, standardized core. It delivers best-practice processes across finance, operations, manufacturing, supply chain, inventory, project services, being kept current with quarterly innovations. Executives gain real-time visibility and control with embedded analytics, workflow automation, and SAP Business AI for anomaly detection, forecasting, and AP automation. The result: faster closes, tighter cash conversion, improved on-time delivery, and fewer manual workarounds. Designed for scale, S/4HANA Cloud Public Edition supports multi-company, multi-location, multi-country operations, global compliance, and role-based security. A “clean core” approach allows for unique configurations while SAP Business Technology Platform (BTP) simplifies integrations and extensions so upgrades stay simple and predictable. The platform’s in-memory architecture (HANA) powers instant reporting on live transactional data, enabling CFOs, COOs, and CIOs to move from reactive to proactive decision-making. Commercially, the solution uses transparent subscription licensing aligned to user roles and modular line-of-business capabilities. Customers can start small and expand as needs grow adding advanced planning, embedded analytics, or industry capabilities without disrupting the core. Whether you’re standardizing one site or orchestrating multiple entities, SAP Cloud ERP provides a single source of truth for sales, operations and finance. Navigator Business Solutions is an SAP partner focused on mid-market ERP transformations. We help define your roadmap, implement fit-to-standard processes, migrate data, connect third-party systems, and enable your teams accelerating time to value while reducing risk. If you’re considering a ERP transformation project, include SAP Cloud ERP on your list. This is not your father's ERP
-
AizonAizon: Intelligent GxP Manufacturing Aizon delivers an AI-powered platform that redefines how pharmaceutical and biotech manufacturers operate under GxP requirements. Our solutions empower teams to enhance efficiency, raise yields, and maintain the highest standards of product quality. - Aizon Execute — Intelligent Batch Record (iBR): Digitize production quickly to reduce manual errors, lower deviations, and accelerate the release of compliant batches. - Aizon Unify — Contextualized Intelligent Lakehouse: Connect and contextualize data from diverse sources to improve decision-making and achieve operational excellence. - Aizon Predict — GxP AI Industrialization: Use predictive AI models to fine-tune critical process parameters, increase Right-First-Time outcomes, and deliver higher manufacturing performance. Aizon enables manufacturers to move beyond traditional compliance and embrace true operational intelligence—learning from the past, acting decisively in the present, and innovating for the future.
-
CanditechCanditech equips HR professionals and hiring managers with the tools they need to make swift, confident, and impartial hiring choices. Its comprehensive testing platform assesses both technical and interpersonal skills through job simulation evaluations that encompass a range of tasks such as coding, SQL, Excel, and video communication. These assessments serve as strong indicators of a candidate's future job performance and overall fit for the role. By adopting a holistic perspective, the platform enables recruiters and hiring managers to fairly evaluate candidates for various positions across the organization, including departments like R&D, Marketing, Sales, and Customer Support. Candidates are also given the opportunity to demonstrate their technical abilities alongside their soft skills, fostering a positive experience throughout the hiring process. From the outset, the platform delivers impressive returns on investment: ✅ Cut down the time-to-hire by 50% ✅ Minimize unnecessary interviews by 80% ✅ Enhance diversity in hiring and mitigate bias Ultimately, Canditech not only streamlines the hiring process but also promotes a more equitable evaluation of potential employees.
-
PropelPropel helps product companies accelerate innovation by unifying lifecycle management, quality processes, and product information in a single platform. With centralized data and built-in governance, every team—engineering, quality, operations, and commercial—can work from the same source of truth. The result is stronger collaboration, faster decisions, and a more reliable path from concept to customer.
-
PackageX OCR ScanningThe PackageX OCR API transforms any mobile device into a powerful universal label scanner capable of reading all types of text, including barcodes and QR codes along with other label information. Our advanced OCR technology stands out in the industry, employing unique algorithms and deep learning techniques to efficiently extract data from labels. With a training dataset comprising over 10 million labels, our API achieves an impressive scanning accuracy exceeding 95%. This technology excels even in low-light environments and can interpret labels from various angles, ensuring versatility and reliability. By developing your own OCR scanner application, you can significantly reduce paper-based inefficiencies. Our OCR capabilities extend to both printed and handwritten text, making it adaptable for various use cases. Furthermore, our software is trained on multilingual label data sourced from more than 40 countries, enhancing its global applicability. Whether it’s detecting barcodes or extracting information from QR codes, our OCR solution provides comprehensive scanning functionalities. The versatility and precision of our API make it an essential tool for businesses seeking to streamline their information capture processes.
What is OpenText for Life Sciences?
OpenText™ Information Management solutions provide life sciences organizations with the tools needed to leverage data and content insights, improving their decision-making processes and accelerating product development timelines. These solutions facilitate the smooth integration, management, and secure exchange of information across individuals, systems, and devices. By optimizing the use of information assets from research and development to commercialization, companies can take advantage of flexible cloud-native software that functions seamlessly in various environments. OpenText specifically tailored for the life sciences sector greatly speeds up the discovery phase, enabling the extraction of actionable insights that drive innovation throughout the development pipeline. Users can transform research articles into electronic lab notebooks via intelligent capture and harness text mining techniques to reveal valuable insights. Furthermore, the platform excels in extracting knowledge from unstructured text found in clinical trial reports, study protocols, and data pertaining to clinical safety and efficiency. It also provides tools for the intelligent analysis, categorization, and extraction of information from clinical trial documents, thereby reducing the likelihood of costly delays and disruptions in the development process. By harnessing these advanced features, life sciences organizations can significantly improve their operational efficiency and propel their research initiatives forward while remaining competitive in a fast-evolving field. The integration of these tools ultimately enhances collaboration and innovation across the entire organization.
What is Kalypso Accel for RIM?
Kalypso provides an economical option for life sciences companies aiming to adopt a Regulatory Information Management (RIM) system called Accel for RIM. This innovative platform supports a cohesive strategy for efficiently managing and overseeing product registrations, while also improving submission accuracy and handling global Unique Device Identification (UDI) details, which helps in optimizing product distribution. Furthermore, it integrates compliance and quality data from various enterprise systems into a single, reliable source for tracking product registrations, thus speeding up the regulatory submission process. By leveraging modern APIs, the system compiles product information along with essential regulatory documents and submission packages. Designed for quick implementation, it is based on a validated software framework that incorporates industry best practices and proven successful deployments. Companies that implement this solution can anticipate not only increased operational efficiency but also a notable decrease in the time required for regulatory activities. Additionally, this streamlined approach can significantly enhance organizational productivity and focus on strategic initiatives.
Integrations Supported
Amazon Web Services (AWS)
Google Cloud Platform
Microsoft 365
Oracle Cloud Infrastructure
SAP Cloud Platform
SAP HANA
SAP S/4HANA
Salesforce
Integrations Supported
Amazon Web Services (AWS)
Google Cloud Platform
Microsoft 365
Oracle Cloud Infrastructure
SAP Cloud Platform
SAP HANA
SAP S/4HANA
Salesforce
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
OpenText
Company Location
Canada
Company Website
www.opentext.com/products-and-solutions/industries/life-sciences
Company Facts
Organization Name
Kalypso
Date Founded
2004
Company Location
United States
Company Website
kalypso.com/industries/life-sciences/digital-regulatory-information-management/
Categories and Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management