Enables Pharmaceutical and Biotech companies to integrate their Quality Management Systems operations across their global enterprise, fostering compliance with GxP.

Even with robust Quality Management Systems (QMS) in place, pharmaceutical and biotech companies can still face unforeseen risks that reduce the effectiveness and compliance of their systems. This is particularly the case when facing the challenges of controlling changes across multiple sites in a global enterprise, answering to auditors and inspectors in a consistent manner across these sites.

Designed for the highly regulated life sciences environment, License for Quality provides end-to-end document and Quality process management. With License for Quality, data can be captured, reviewed, processed and approved through an interface that works as a single point of access to the company compliance content.

License for Quality provides a number of benefits that help pharma and biotech companies integrate and enact their Quality Management Systems across their global operations. License for Quality allows access to QMS documents and data from anywhere, with full traceability of each of the processes addressed. With secure, audited data sharing, organizations will be able to demonstrate adherence to quality processes and minimize recall occurrence.

With License for Quality, enterprise organizations can improve yields, reduce the number of issues and minimize recall occurrence, thereby improving both product quality and quality processes  needed to reduce risk.

Enable Pharmaceutical and Biotech companies to take control of regulatory affairs and regulatory operations across their global enterprise, fostering compliance and improving regulatory submission efficiency.

Regulatory requirements can challenge the most dedicated and process-driven organizations. With numerous and frequently changing regulatory areas to focus on, the challenges grow when trying to manage and synchronize information and content from CRO’s, CMO’s and other partners. The challenge then becomes how to effectively manage the changes, and the flow of material from various partners and sites. Without effective management, regulatory hurdles can quickly clog the new product pipeline.

License for Regulatory enables life science companies to take control of quality and regulatory operations across their global enterprise, fostering compliance and improving operational performance. Designed for the highly-regulated life sciences industry, License for Regulatory provides end-to-end document and workflow management in alignment with regulatory guidances to reduce costs, improve efficiencies and accelerate submission of marketing applications to the appropriate regulatory bodies through improved regulatory submission assembly, review and approval processes.

License for Regulatory shortens content review and approval cycles by up to 40% by enabling higher quality submissions with less iteration, thereby improving successful submission creation and maintenance. And with a flexible, out of the box system complete with validation test scripts to accelerate deployments, biotech and pharmaceutical companies will see reduced IT costs that match their needs for fixed costs solutions and pre-defined configurations.

Key Benefits : 

• Single platform provides full traceability to R&D requirements
• Shorten content review and approval cycles by up to 40%
• Higher quality submissions with fewer iterations, enhancing chances for success
• Reduces IT and system ownership costs with a flexible, out of the box system complete with a validation package to accelerate deployments
• Compliance with global eCTD standards
• Enables rapid adoption of new regulations or internal changes with flexible configuration capabilities
• Validation-ready and designed for 21 CFR Part 11 and Annex 11 compliance
• Enhances maturity of submissions and document lifecycle processes to mitigate the risk of future compliance mandates.
• Accelerate time to market through improved regulatory submission assembly, review and approval processes

Efficient and compliant management of controlled documents across the enterprise

Pharmaceutical and biotech companies struggle to manage and maintain controlled documents throughout their lifecycle. Functional areas such as Quality Assurance, Manufacturing, R&D, and Regulatory Affairs often create and manage their own silos of content; often with a lot of redundancy that cannot be effectively managed due to disparate systems that do not talk to each other. Developing summaries or universal views for reporting and communicating status of documents across the enterprise can take time and additional resources that increase compliance risk and delay bringing products to market.

License for Document Control addresses these challenges by enabling efficient, complete lifecycle management of controlled documents, from creation to retirement, and ultimately controlled destruction. License for Document Control offers an easy to use, web-based interface that enables viewing, printing, and managing controlled documents across the enterprise, thereby reducing the time and people needed to ensure accuracy and validity of information across all functions. These capabilities include a comprehensive and detailed audit trail to provide irrefutable traceability of all document operations.

License for Document Control reduces development timelines and workflow bottlenecks by enabling simultaneous collaboration by multiple authors and reviewers, as well as streamlining the review and approval process with electronic signatures that are in compliance with 21 CFR Part 11 and Annex 11 requirements.

License for Document Control is a solution that enables pharmaceutical and biotech companies to manage their controlled documents in an efficient and compliant manner across the enterprise. Features such as automated workflows, controlled templates, change control, multi-dimensional permissions, controlled printing, automatic PDF rendering, 21 CFR Part 11 and Annex 11 compliant Electronic Signatures, and an extensive audit trail support GxP as well as non-GxP use across the Enterprise. License for Document Control ensures that every stakeholder has access to the right document at the right time and complete traceability is assured. The solution provides confidence in customer and agency audits with full-text indexing and meta-data searching to find information quickly and easily. Extensive dashboards and reports provide business intelligence to ensure and demonstrate compliance as well as measure business performance.

Key Benefits : 

• Easy to use, web-based interface for viewing, searching, printing and collaborating on controlled content
• Complete document lifecycle management from creation, to retirement, and ultimately controlled destruction
• Content consistency regarding appearance and metadata
• Searching, reporting and dashboard
• Simultaneous collaboration by multiple authors and reviewers
• 21 CFR Part 11 and Annex 11 compliant Electronic Signature
• Extensive and irrefutable Audit Trail
• Web-based administration and configuration management