Every business has to deal with several critical documents on a daily basis. Docmation understands the issues associated with document management and data transfer and offers the following business solutions that make document management simple and less time consuming.

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Medical Communications

Eliminate common medical information challenges, speed-up time to approval, enable better collaboration and improve compliance.

Docmation Medical Information and Communication Solution built on top of EMC Documentum in conjunction with Salesforce CRM simplifies the global coordination of medical communications by providing a single source of the truth for medical content across multiple channels and multiple geographies. Docmation solution manages medical information content such as FAQs, standard response documents and medical letters. With content management functions, such as versioning, audit trail and security, the solution manages the full content life cycle.

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Medical CommunicationsX

Deep medical communications functionality: Medical communications customers will benefit from functionality for response package generation, publications management, local country document creation, expiry management and for medical/legal/regulatory review and approval. In addition, powerful and unique time-based reporting provides insight into process bottlenecks at every level.

Complete Solution: Single solution to manage customer requests, storage content, implement custom business process, and ensure regulatory compliance.

Contact Docmation today to learn how we can help you to automate your Medical Information and Communication business processes.

Trial Master Files

Docmation leverages EMC Documentum Electronic Trial Master File (eTMF), to enable life sciences organizations to easily and effectively control and synchronize study artifacts, track progress in clinical trial documentation, and ensure fast, secure access to documentation both during and after the trial.

The solution ensures reliable regulatory compliance by enabling compliance with Good Clinical Practices (GCP), 21 CFR Part 11 including electronic signatures capabilities and other compliance capabilities such as dynamic user access controls, print controls, and preconfigured, dynamic watermarking and overlays.

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Trial Master FilesX

Streamline document collection, management and analysis.

  • IMPROVED PRODUCTIVITY: Efficiently and securely operate the extended enterprise across geographies and external organizations with workflows, security models and collaboration capabilities designed for enhanced productivity and the virtualization of the clinical trial process.
  • ACCELERATED TRIAL SETUP: Quickly set up trials with reusable templates to ensure consistency for product, trial, country, and site-level artifacts. Streamline processes with auto-filing and auto-naming rules using file planning and workflows to ensure documentation completeness.
  • COMPLETE COMPLIANCE: Enable Good Clinical Practices (GCP) and 21 CFR Part 11 requirements, including electronic signatures and other compliance capabilities such as dynamic user access controls, print controls, and preconfigured, dynamic watermarking and overlays.

 Contact Docmation today to learn how we can help you streamline your clinical trials process with industry leading EMC Documentum Electronic Trial Master File (eTMF) solution.

 

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Regulatory Submissions

Simplify the search and retrieval of archived submissions and their associated correspondence, while improving security and compliance. Link regulatory correspondence and communications to submission files, enabling a full view of regulatory activity.

Faster submissions, improved collaboration and continuous visibility: Life sciences organizations produce large volumes of documentation when submitting applications to regulatory agencies. This documentation includes not only the application itself but all related communications and records of interactions between the company and the regulatory authority.

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Regulatory SubmissionsX

Docmation leverages the EMC Documentum Research and Development solution  to help clients accelerate the creation, review, and approval of regulatory submission documentation. To ensure adherence to industry standards and improve overall productivity, our solution provides predefined taxonomies and business process rules.

IMPROVE DOCUMENT ACCURACY: The Research and Development solution enables organizations to eliminate redundant data entry and improve the accuracy of submission documentation. It leverages out-of-the-box, industry-standard dictionaries and taxonomies of the Drug Information Association (DIA) Electronic Document Management (EDM) reference model.

STREAMLINE REVIEW PROCESS: Allow multiple contributors to make edits and annotations to documents simultaneously, with the solution automatically merging all edits into a single document. Streamline the authoring process with automated workflows, shortening the time for reviews and approvals. 

INCREASE AUTHOR PRODUCTIVITY: Eliminate authors’ need to manually select and create documents by enabling them to select from a predefined inventory of reusable, industry-standard documents that are automatically linked with the associated document types required for a submission.

MINIMIZE COMPLIANCE RISK: Reduce noncompliance risk by automating and enforcing appropriate approval processes. Our solution automatically assigns review and approval workflows based on predefined rules and routes documents to appropriate staff, based on document type.

Contact Docmation today to learn how our Docmation experts can help you improve collaboration and accelerate your regulatory submissions process.

Quality Docs

Docmation has more than 15 years of experience implementing EMC Documentum Quality and Manufacturing solution. It enables life sciences organizations to control quality and manufacturing documents, automate workflows across the extended enterprise, and ensure complete compliance with Good Manufacturing Processes (GMP).

Consistent audit trail, pervasive access and serious regulatory compliance: The EMC Documentum Quality and Manufacturing solution, part of the EMC Documentum for Life Sciences solution suite, enables life sciences organizations to control quality and manufacturing documents, automate workflows across the extended enterprise, and ensure compliance with GMP standards.

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Quality DocsX

The solution enables auditing, reporting, and e-signature support for compliance, lifecycle management, and document control services, and industry-specific modeling capabilities. 

For the extended enterprise operating across geographies and with external partners, the solution enhances the productivity and virtualization of your global supply chain with streamlined workflows, bullet-proof security models and collaboration capabilities.

COMPLETE COMPLIANCE: Achieve compliance with GMP standards through enhanced, automated management of standard operating procedures and process control documents.

CENTRALIZED CONTROL: Centralize corporate document control and visibility, while enhancing local productivity with a solution that unifies document creation, approval, change control, and retrieval, and also provides flexibility in workflows and document lifecycles.

SECURE MOBILE COLLABORATION: Seamless integrations with mobile devices allow easy distribution of effective documents, enable secure synch and share across devices, and the ability to participate in workflows on the go.

Contact Docmation today to learn how we can help you automating quality control document management.

 

Controlled Document Management System for Contract Manufacturer

Client is a leading Contract Development and Manufacturing Organization(CDMO) serving the pharmaceutical industry and offering its customers with a wide range of comphrehensive services beginning from the development through the manufacturing of a variety of drugs. Providing outsourced services to the pharmaceutical market involved organizing and integrating issues. In order to streamline the process and to offer its services in a more coherent and standardized manner, the client opted for a rapid expansion.

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