Agatha
Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11.
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Polarion REQUIREMENTS
Effectively gather, author, approve and manage requirements for complex systems across entire project lifecycles. Facilitate synchronicity and easy access via 100% browser-based access to all Polarion data. Enable real-time communication between analysts, engineers, QA members and DevOps teams etc. via threaded discussions, wikis, notifications, alerts & more. Pass any audit, compliance, or regulatory inspection with traceability that is easily implemented and guaranteed via automatic change control of every requirement. Manage work items and documents via workflows that enforce how and when they move from state to state based on definable rules, with full audit trails, electronic signature and security. An exclusive innovation, Polarion LiveDocs, enables you to collaborate concurrently and securely on specification documents with having every single paragraph uniquely identifiable and traceable.
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Carizma QM
Carizma QM is a web-based software that supports users in managing the entire lifecycle of regulated documents from authoring, review, approval and release to archiving. Creation and management of regulated documents, e.g. SOPs. Integrated workflows for review and approval. Automatic start of training workflow, read and understood upon approval. Electronic signature – 21 CRF part 11 compliant. Display of users who have read and understood. Validated and audit trail. Supports users to manage the entire lifecycle of regulated documents within Carizma-QM itself. The author defines key information e.g. document type (SOP, work instruction, form, checklist, etc.), title of document, process owner (department), groups of users to whom the document is applicable, review cycle. Users are defined in due time by e-mail when a document needs to be reviewed. Carizma creates the skeleton document.
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ECM-X
The cloud platform for electronic document management. ECM-X is a next generation system that can be used by any size company and any industry. Many legacy document management systems are large and complex which require 1-2 weeks of training, resulting in low adoption. ECM-X has been designed from the ground up to ensure ease of use and minimal training. ECM-X system could be deployed on local company servers or on any cloud environment in the USA and Canada. Our document management system, named ECM-X, is an easy to use, scalable, Internet based software system that can manage millions of documents. It can store practically any type of file such as Microsoft Office suite of products and Adobe PDF files. With ECM-X workflow module, you can route your documents such as engineering designs, invoice approvals, expense reports, cheque requests, or employee on-boarding for reviewing or approving.
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