Electronic Document Management System (EDMS) Software for Life Sciences

Expedite Document Management Processes in Life Sciences Manufacturing with EDMS Software

Regulations set forth by the FDA, EMA guidelines, ISO quality standards, and similar requirements serve to ensure the quality and efficacy of life science products, including pharmaceuticals and medical devices. The successful implementation of an effective and proven life sciences document management system can greatly simplify compliance with regulatory standards in the life sciences manufacturing industry.Presently, a wide array of electronic document management systems (EDMS) is available from numerous providers, varying greatly in terms of robustness and ease of use. The crux lies in identifying the EDMS system that best suits your life sciences organisation's document control software requirements.

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MasterControl's Life Sciences EDMS Software: Compliant, Connected, and Comprehensive

It is paramount to recognise that regulatory compliance of an electronic document management system for life sciences is an ongoing process, rather than a one-time event. With this in mind, organisations must assess other crucial factors before implementing EDMS software, such as: file location and retention, document retrieval requirements, level of security needed, document recovery in case of disaster, archival needs, workflows, document creation criteria, tracking, and so forth. While every life sciences organisation has unique document management needs, a variety of EDMS systems are available to meet these requirements in the pharmaceutical and medical device manufacturing sectors.

Since 1993, MasterControl Inc. has been a leading global provider of electronic document management software for life sciences. MasterControl's document control software is both integrated and exceptionally user-friendly. The MasterControl EDMS software ensures life sciences companies remain compliant, connected, and comprehensive, year after year.

Document Management (eDMS) Resources

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Data Sheet: MasterControl Documents Data Sheet: MasterControl Change Control
Industry Brief: How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
White Paper: Automating Document Control Processes to Comply With FDA and ISO Requirements

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Compliance in Life Sciences:

MasterControl's EDMS software enables life sciences companies to maintain a constant state of readiness for regulatory inspections and audits. Key compliance features for pharmaceutical and medical device manufacturers include:

Automation of document routing, escalation, and approval in compliance with FDA and EMA regulations.
Direct linkage of InfoCard metadata to documents for enhanced traceability.
Facilitation and tracking of all document changes in accordance with life sciences regulatory requirements.
Analytics and reporting functionality tailored for life sciences compliance.

Connected EDMS for Life Sciences:

MasterControl's electronic document management software integrates with other quality processes to ensure efficiency and continuous improvement in life sciences manufacturing. MasterControl's EDMS software provides:

A web-based platform designed for pharmaceutical and medical device manufacturers.
Integrated quality management (CAPA, deviations, nonconformances, etc.) specific to life sciences.
Integration with other applications such as employee training, bill of materials (BOM), supplier management, etc., crucial for life sciences manufacturing.
Enhanced visibility in complex life sciences document ecosystems.

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Electronic Document Management System (EDMS) Software for Life Sciences