KOŚA DMS
KOŚA DMS is a cloud-based document management system for pharmaceutical, biotechnology, medical-device and other life-sciences organizations. It supports controlled document creation, review, approval, release, distribution and revision tracking, with workflows for SOPs, policies, forms and other quality records. Teams can manage role-based access, electronic signatures, audit trails, periodic reviews and controlled copies to maintain traceable document histories for regulated processes. Microsoft Word integration supports document drafting within familiar authoring workflows, while ERP and LIMS connections can link documentation with operational systems. The system is intended for quality assurance, quality control, regulatory affairs and document-control teams that need to coordinate document lifecycle activities across sites, functions and regulated operations.
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MediaLab Document Control
MediaLab’s Document Control is a powerful way to manage your laboratory’s policies, procedures, and documentation. Our twenty years of expertise in clinical laboratories have created a document control solution that guides you to full compliance with all laboratory standards, regulations, and best practices. Document Control provides an automated, centralized platform for all of your document approvals, workflows, edits, sign-offs, audits, and more—with flexibility and customization features to match your laboratory’s unique needs.
MediaLab's Document Control supports:
• Digital records and version control of all documents,
• Standardization across all documents from all sites,
• Electronic signatures that meet 21 CFR Part 11 standards,
• Customized approval workflows and processes,
• Robust searching to easily locate specific documents, and more!
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Assai
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Assai's DMS stores all your documents, drawings, correspondence, emails, contracts, and purchase orders in a central, easily searchable repository. You control access, and always have the latest versions available to your team. Search functions let you quickly find what you need using metadata or content. Our Document Control system streamlines workflows, with easy setup and maintenance, user inboxes, automatic assignments, and flowchart tracking. We offer Enterprise Content Management that enable complex projects and operations. Get a grip on your projects, assets, documents and data with our Common Data Environment.
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Clearlane Controlled Documents
Clearlane Controlled Documents brings document control for quality management systems into Confluence Cloud, turning pages such as SOPs, work instructions and policies into controlled documents. Named approvers sign each revision with a personal signing password; each electronic signature is bound to the exact content using a SHA-256 fingerprint, and edits during review void the signature. After the final signature, a revision becomes effective and receives its next review date. Readers confirm the current revision, periodic reviews trigger reminders, and a register lists each space’s documents. Users can generate an evidence PDF with signatures, revisions, read confirmations and the audit trail. The app is for pharma, biotech, medtech and ISO 9001 quality teams, and supports English, French and German. It helps teams meet 21 CFR Part 11 and ISO 13485 requirements. Built on Atlassian Forge, it stores data in the customer’s Atlassian site.
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