We understand the importance of every detail and work as an extension of your quality department, ensuring accurate and efficient document management for your medical device company.
We are recognized internationally as Subject matter system experts and advanced users within MULITPLE global world-leading enterprise quality management systems.
As a MasterControl service partner, iDE8 can support your business with all aspects of your MasterControl environment.
Contact us today to learn more on how we can assist your team.
Computer System Validation
MasterControl Inc. is a leading provider of cloud-based quality and manufacturing software for life sciences and other regulated industries. For three decades, our mission has been the same as that of our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality and manufacturing processes. Innovative MasterControl tools have a proven track record of improving product quality, reducing cost, and accelerating time to market. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze and interpret large amounts of data, and visualize business insights in real-time. For more information, visit www.mastercontrol.com
Supporting your DIGITAL eQMS documentation systems..
Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.
Supporting your Quality Management Teams in the day-day operations and management of your EQMS.
Providing support with validation lifecycle activities to prove that your system works in its intended environment.
Conducting gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.
(IaaS, PaaS, SaaS)
Validation Support of cloud-based systems, ensuring compliance to International regulations.
21 CFR Part 11 Compliance
Provide guidance in ensuring your electronic records and signatures are considered to be trustworthy and equivalent to paper records.
We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.
Working with you to Define strategies for handling changes systematically so that a system maintains its integrity over time.
SOFTWARE SUPPLIER AUDITS
Carrying out audits on vendors of software and systems and providing documentation to support your validation strategy and demonstrate regulatory compliance.
Supporting you in the development of compliant approach's to your computer system validation.
Verifying the reliability of your spreadsheet and its output for its intended use.