Compliance Solutions

Information Technology

By building compliance strategies with clients, not for clients, Sensyo develops IT strategies that achieve a return on investment

Information Technology Compliance Solutions

Sensyo develops decisive strategies and tactics based on technical expertise, compliance insight and scientific excellence to align all actions with business goals.

The resulting compliance IT strategy addresses business and compliance needs, capitalizes on opportunities for operational improvement and provides a process for transferring knowledge to internal resources. We help clients in:

• Understanding and implementation of electronic records and signatures
• Remediation and validation of non-compliant systems
• Bridging the gap between legacy systems, regulatory compliance and continued use of an existing system
• Assessing the compliance impact of new technology on existing systems
• Measuring the current degree of compliance against regulatory standards
• Keeping up to date with the latest regulatory agency interpretations, country-specific GxP guidelines, and audit findings

Our technology and compliance expertise includes:

• Content/Document Management systems
• Electronic Regulatory Submission systems
• Laboratory Information Management Systems (LIMS)
• Data Collection Systems
• Clinical Data Management Systems
• Enterprise Resource Planning (ERP)
• Enterprise Electronic Data Management (Paperless)
• Legacy Data Management
• Archiving Strategies
• Integrated Laboratory Productivity Tools
• Public Key Infrastructure (PKI)
• Databases
• Software Development
• Security

Our documentation support includes:

• Requirements
  Expediting design, development, implementation, maintenance, validation and regulatory inspections with organized, concise functional requirements that ensure the system is fully understood and implemented accordingly
• Design Specifications
  Verifying that design specifications and testing correlate to functional requirements with a treacability matrix that demonstrates all critical requirements are met through design, testing and validation
• Hardware/Software Selection
  Identifying the most appropriate solution for the business needs. Developing requests for proposals. Acting as a liaison with suppliers and product manufacturers. Analyzing supplier quotations. Auditing Vendors and ensuring sound selection.
• Risk Assessment
  Identifying the right approach to validation of complex systems, such as Enterprise Resource Planning systems and systems integration, which may cover GxP and non-GxP functions.
• Data Migration
  Transitioning data from legacy systems to new IT systems with minimal impact on existing operations.
• Validation
  Accelerating network qualification and system validation with documented standards and templates. Planning and controlling system acceptance testing as IQ and OQ in order to avoid the need to reformat and re-execute validation tests.
• Inspection Preparation
  Conducting compliance assessments to identify potential areas on non-compliance and creating remedial action plans to address compliance gaps and reduce exposure to regulatory actions.