ComplianceWire

More than 200 pharmaceutical, medical device and biologic companies rely on ComplianceWire® to organize, distribute and monitor all training and qualification activities, such as organizing users, building curricula, sending assignments and much more. The system is used by the FDA to manage their training of 30,000 inspectors.

Fully Validated LMS

ComplianceWire is a fully validated learning management system, leveraging the Software as a Service (SaaS) model, that ensures compliance with 21 CFR Part 11 requirements. ComplianceWire supports the quality and validation constructs defined by Good Automated Manufacturing Processes (GAMPs) and GxPs, including:

  • Electronic signatures and records
  • Audit logs
  • Record versioning
  • Data security
  • Fully documented SDLC
  • Quality systems
Build a Centralized Repository

ComplianceWire serves as the single learning repository for an FDA-regulated enterprise, so that audit records can be generated with little effort. You can store both employee and non-employee records in a single system, separated by security nodes that limit access. ComplianceWire supports many types of training, including:

  • Computer-Based Training (supporting SCORM and AICC)
  • Instructor-Led Learning
  • Control Documents that include links to SOPs, policies, etc.
  • CVs (Optional CV upload)
SOP Management

ComplianceWire enables companies to manage the distribution of SOPs, corporate policies, forms, surveys and routine communications with documented electronic receipt and tracking to employees, suppliers and contractors. The system integrates easily with many Document Management Systems (DMS) to trigger automatic assignment updates, greatly reducing administrative time.

Tools for Measuring Qualifications and Proficiency

ComplianceWire elevates learning management to knowledge management by including a number of optional tools that measure knowledge and proficiency. For example:

  • Managers can use our Forms tool to capture on-the-job training
  • Quizzes can be created and linked to SOPs and critical documents to test understanding following document review
  • Exams can be created as stand-alone training items to gauge a learner's existing knowledge before receiving curricula
  • Our CV Builder tool can integrate a CV into an employee's qualification profile