As members of the life sciences community, there are numerous standards that must be understood and followed to maintain compliance. InnovX coach and guide your team on how to best meet those standards, and which ones truly apply to your operations. Compliance is a wide field of knowledge where different building blocks are at play (i.e. regulations, industry best practices, and standards) based on your specific industry segment, the role you play in this ecosystem, and the scope of compliance you are concerned with.
Training program structure, refine training matrix to configure new learning management systems (LMS) & training support for employees.
COMPUTER SYSTEM VALIDATION
Aligned with GAMP 5 methodology, assisted computerized systems validation focused on medical devices, clinical research, pharma & laboratory work.
SYSTEM GAP ASSESSMENTS
Evaluation of enterprise resource planning (ERP) and quality management systems (QMS). Internal system appraisal and regulatory assessments.
Ensuring an adequate qualified GXP cloud-based or on-premises applications, infrastructure verification & technology stack control systems.
IT POLICIES & PROCESS DEFINITIONS
Development & implementation of control functions for establishing proper information technology effectiveness in regulated organizations.
Defining a plan suitable for your business. Define a taxonomy for the records being produced, system selection for electronic records and electronic signatures.
Good documentation practices (GDP) implementation, record digitization.
IT service provider assessment, key element verification, define or redefine vendor assessment forms & train your personnel to do it themselves.
TURN KEY COMPLIANCE SOLUTIONS
When we get involved in system compliance, as is required in the context of validation, we follow a risk-based approach. This allows system compliance efforts to be targeted towards features that are most crucial to maintain patient safety, drug safety, and data integrity. This also ensures that all efforts are focused on the most important aspects of your operational compliance, without spending valuable time trying to validate elements that do not require a high level of scrutiny.
Whether you need to address enterprise compliance or system-specific compliance in any of the regulated segments of the life sciences industry, InnovX can help.