Your company is part of a demanding and highly regulated industry. From work instructions to standard operating procedures to sales literature, you have to manage a multi-step process that must comply with regulations and remain accountable at all times. DocXellent understands that seemingly harmless oversights can delay the launch of new products and result in lost revenue.
With DocXellent’s document control software, Life Sciences companies manage and control documentation, easily streamline and automate their workflow, and save time and manpower managing document versioning standards and approvals. Rest assured that our experience in working with Life Science companies will help you exemplify GMP and ISO requirements for document control and stay 21 CFR Part 11 compliant. As a total quality management solution, ENSUR provides all the tools needed to meet ISO quality standards, regulations, and industry requirements.
DocXellent helps meet your key objectives:
- Maintain FDA 21 CFR Part 11 compliance
- Manage versioning of SOPs, Work Instructions, Policies, Labels, Specifications, and more
- Adhere to ISO quality standards
- Multi-layered Automated Document Security
- Electronic Signatures
- Reporting and Accountability
- Incident Management
- Corrective Action Preventative Action Management
- Product and Packaging Specification Management
- Employee Training Management
- Multi-department collaboration
- Automated Notifications & Distribution
What is the Life Science and Biotech Industry?
The Life Science and Biotech industry comprises several areas of science-based business, including pharmaceuticals, medical devices, cosmeceuticals, biomedical technologies, and more. Organizations in the Life Science and Biotech industry need to adhere to a number of industry regulations and continuously demonstrate compliance, making streamlined document management essential.
Features of a DMS and QMS system for the Life Science and Biotech Industry
Document management systems and quality management systems for the Life Science and Biotech industry include the following features:
- Audit trails
- Change control
- Document control and training
- Electronic signatures
- Advanced searching of content
- Incident tracking
- Multi-site capabilities
- Training management
- Multi-layered security
Improve Efficiency and Compliance Industry Wide
Document management systems allow the Life Sciences and Biotech industry to improve efficiency and compliance through automation. By automating document processes, organizations can effectively store, retrieve, approve, edit, and share documents in compliance with industry standards and regulations.
Life Science and Biotech FAQ:
What are the benefits of using an eQMS for pharma and Biotech companies?
Pharmaceutical and Biotech companies are under constant, strict scrutiny in their highly regulated industries. E-quality management systems (eQMS) are tools that ensure they meet regulatory and industry requirements. See the following benefits when you opt for a Biotech quality management system:
- Ensured compliance with standards for change control, document management, and more
- Mitigated risk with a closed-loop system
- Maintained, consistent product quality
- Scalability as your organization grows
- Improved process integration for better efficiency, productivity, and cost-effectiveness
- Improved data and information analysis for smarter decision-making
- Better relationships with suppliers
- Support for a culture of continuous improvement
What is a Life Science and Biotech DMS?
A Life Science and Biotech document management system (DMS) is software that enables you to manage and control your organization’s documentation. It allows you to automate workflows, track document versions and approvals, obtain electronic signatures, and more. You can optimize document-heavy processes with a centralized platform, like ENSUR, that is easy to use and streamlines the storage, sharing, updating, and tracking of all your documentation. Document software for Life Sciences can also serve as a training management solution and a quality management system.
How can a DMS system improve efficiency?
A Life Sciences document management system improves efficiency in several ways:
- It centralizes all document tracking, storage, and sharing so employees don’t waste time manually searching for files or figuring out where resources live.
- With automation, a DMS speeds up incident management, document creation, approval processes, reporting, training, specification management, and multi-department collaboration.
- The right DMS ensures compliance in each step of every process, so you don’t have to backtrack to adhere to regulations and can master your Life Science quality management.
- Multi-layered document security automates your compliance and security efforts for better efficiency and more effective document protection.