FDA Compliance
Background
Manufacturers of medical devices are required to meet stringent FDA standards for product and software validation. As the usage of software tools to adhere to these guidelines increases, the support for validation becomes more critical. We are able to guide your business through these regulations and understand that:
- Risk analysis and requirements drive the validation
- Good validation is good for business, in addition to regulatory compliance
Software Validation and Verification (V&V)
Includes Concept / Proposal Documents, Validation Plans, User and Functional Requirements Specifications, Risk Assessment Reports, Software Design Specifications, IQ/OQ Documentation, Test Protocols and Test Reports for:
- Product Lifecycle Management (PLM) Systems
- ERP (Enterprise Resource Planning) Systems
- EDM (Enterprise Documents Management) Systems
- Preventative Maintenance Systems
- Labeling Software
- Medical Device software
- Incremental Validation of Software Systems (upgrades)
21 CFR Part 11
FDA ruling 21 CFR Part 11 specifies how electronic records and electronic signatures can be used as a substitute for paper records and handwritten signatures. It is broadly applicable to electronic
records, including software, that are central to the process of developing and manufacturing drugs and medical devices, and research and biotechnology.
We deliver evaluation and remediation planes for guideline compliance.
Audit Remediation
Work with QA and Regulatory Affairs to remedy audit findings.
ISO13485 / Current Good Manufacturing Practices (cGMP)
- Gap Analysis - Perform system and software gap analysis for fiscal decisions
- Workflow & Process Diagramming - Visual diagrams of workflow and process flow to support development and documentation requirements
- SOP & DOP - Generation and revision of operation procedures for quality assurance purposes
- Work Instructions - Develop work instructions specific to customer use of software applications
- Business Process Flow Mapping - Creation and delivery of current and optimal state business process flowcharts
- Technical Manuals - User guides, Service Provider Manuals and Release Notes
- Training Programs - Create and proctor hardware & software training
Project Management
- Macro and Micro schedules
- Communications with key stakeholders
- Escalation management
- Regular project status meetings
- Aggregation and presentation of data
