No! Trievr can serve as a useful bridge between any business and it’s outside partners related to:
- Managing Audits
- Complaint Management
- Compliance Management
- Non-Conformance Management
- Research Study Management
- Specification Management
- Document Management
- Quality Agreements Management
- Product Release Management
- Recall Management
Trievr works within many industries, such as;
- Insurance
- Medical
- IT
- Health
- Car Manufacturers
- Products/Parts Manufacturers
- And many more…
It takes only minutes to sign up for Trievr’s 30-day full access trial. Once registered, we have step by step tutorials and live chat to instant customer service.
GxP is an acronym that refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications.
The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers and to ensure the integrity of data used to make product-related safety decisions.
The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and others, each of which has product-specific requirements that life sciences organizations must implement based on the 1) type of products they make and 2) country in which their products are sold. When life sciences organizations use computerized systems to perform certain GxP activities, they must ensure that the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system.
In the United States (US), GxP regulations are enforced by the FDA and are contained in Title 21 of the Code of Federal Regulations (21 CFR).
Within 21 CFR, Part 11 contains the requirements for computer systems that create, modify, maintain, archive, retrieve, or distribute electronic records and electronic signatures in support of GxP-regulated activities. Part 11 was created to permit the adoption of new information technologies by FDA-regulated life sciences organizations, while simultaneously providing a framework to ensure that the electronic GxP data is trustworthy and reliable.
Yes. Trievr delivers proven regulatory compliance practices for document control and related training across the business.
Delivering compliance with FDA 21 CFR Part 11 including Electronic Signatures and Audit Trail, SOP management, Policies, Procedures, Work Instructions, Manuals, Files and Reports will be created and controlled in compliance with global regulatory mandates.
Trievr’s request management solution is FDA GxP compliant and facilitates effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform. Trievr’s request management solution goes beyond FDA 21 CFR Part 11 requirements and regulations to help companies also sustain current industry “best practices (CGxP). Trievr continues to go beyond requirements for implementing a GxP process management software solution for easier compliance, faster validation, and better CGxP process management. Find out more from our Johnson & Johnson case study.
Security, Availability, Processing Integrity, Confidentiality, and Privacy
Those are the five core principles which should be built into the control structure of any top tier Data Center / Colocation / Hosting facility. Making use of a Data Center with a successfully completed SSAE 16 (SOC 1) or SOC 2 report covering a combination if not all of the principles is integral to ensuring your business applications and data are maintained in an environment that won’t fail you or your customers.
Trievr’s private cloud GxP compliant SaaS, uses an SSAE 16 Data Center / Host to address compliance concerns such as;
- Maintains sufficient Data and Power Redundancy
- Maintains appropriate Physical Security Controls (Man Trap, Security Guards, Biometric Scanning, Video Cameras)
- Monitors for excessive Temperature Fluctuations
- Reviews Alerts on a Timely Basis .
- Has proper Fire/Water Detection and Protection
Trievr uses only the highest quality provider for its private cloud based service.
Private cloud is a type of cloud computing that delivers similar advantages to public cloud, including scalability and self-service, but through a proprietary architecture. Unlike public clouds, which deliver services to multiple organizations, a private cloud is dedicated to a single organization. Trievr is on a private cloud.
Software as a Service (SaaS)
In Life Sciences, the Software as a Service (SaaS) model has been around for quite a while. Examples of this model in Life Sciences include clinical trials EDC software. Examples in the consumer space are e-mail applications such as Hotmail. Both types of software are provided completely hosted, completely managed, so that the customer need not worry about servers or storage capacity or infrastructure management. Examples of Software as a Service include software in such categories as:
- Business Productivity
– Email
– Collaboration Services - CRM and XRM services
- Electronic Data Capture (EDC) in Clinical Trials
- Regulated Document Management services
- Clinical Trial Portal