Companies regulated by stringent FDA and EU guidelines know how vital it is to effectively and efficiently manage all of their processes and the large volume of documents that go along with them. MasterControl’s enterprise document management software is designed to integrate and automate all of the functions and quality processes within a life science company.

About MasterControl Inc.

MasterControl Inc. is a leading global provider of GxP process management software helping companies within regulated environments attain and sustain compliance to industry and company best practice standards. MasterControl suite includes enterprise document management software, and also includes a continuum of risk-based software validation products and services that are easily configured to meet the specific needs of each regulated company. Hundreds of companies worldwide use MasterControl enterprise document management software for easier compliance, faster validation, and better GxP process management.

Document Management Dowloads

	White Paper Download: Automating Document Control Processes in FDA and ISO Environments
	White Paper Download: Standard Operating Procedure ( SOP ) Management as a Compliance Tool in FDA and ISO Environments
	White Paper Download: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
	White Paper Download: 21 CFR Part 11 - Risks of Noncompliance

Solve the Top Five Enterprise Document Management Challenges with MasterControl GxP Process Management Software SolutionsEnterprise document management

is not an easy task. Many life science companies struggle to manage company processes because they are still employing outdated paper based or partially electronic modes of management. With over a decade of experience in the FDA and EU environments, MasterControl enterprise document management software provides solutions for the following challenges:

1. Inefficient routing and tracking.MasterControl Enterprise Document Management Solution: offers an automated electronic system connected to the web so management can always know the complete history of each document, from creation to storage
   
   
2. .Lack of mechanism for escalation.MasterControl Enterprise Document Management Solution: the electronic, web-based system keeps employees and customers connected and allows documents to escalate to the next person in line for review or approval.
   
3. Ineffective revision control.MasterControl Enterprise Document Management Solution: features an FDA-compliant revision control feature that automatically archives obsolete documents, locks documents being revised, and only allows authorized, current versions to be viewed.
   
4. Lack of secure, centralized repository.MasterControl Enterprise Document Management Solution: is in accordance to 21 CFR 11 by only allowing access to authorized users holding them accountable for actions initiated under their electronic signatures.
   
   
5. Inefficient process for obtaining signatures. MasterControl Enterprise Document Management Solution: provides e-signature manifestation that can be configured to include a user's name and title and the route step name. This ensures that different kinds of approval are distinguished according to GxP standards.

GxP Lifeline—a Virtual Space of Learning and Collaboration

GxP Lifeline is a complimentary monthly newsletter dedicated to life science industry issues, especially those companies involved in the pharmaceutical, medical device, CRO, blood/biologics, clinical/medical laboratory, and biotechnology industries.

Each newsletter consists of general feature articles; life science industry information; articles for specific sectors; and life science industry events including conferences, trade shows, and more. MasterControl hopes that each company will take advantage of this dynamic virtual space for continued learning and collaboration.

Contact MasterControl Online

MasterControl provides time-tested implementation , validation , and product training services to help companies realize faster ROI on their enterprise document management software.

To learn more about enterprise document management, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

Related Items:

• Document Management Process
• Document Management Program
• Document Management Project
• Document Management Record
• Document Control
• Project Document Control
• GMP Guidelines
• GMP Regulation
• Internal Audit Reporting
• Market Regulated