Veracord delivers high-quality, results-focused GXP consultancy services to the biopharma and healthcare industries.
Our services and expertise cover the following areas:
- Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP) validation and lean compliance support
- Computer system compliance and validation in order to meet regulatory requirements and guidelines including 21 CFR Part 11, Annex 11 and GAMP
- Flexible Regulatory Compliance, Quality Assurance (QA) and Qualified Person (QP) support
- Training, coaching and knowledge transfer
Veracord’s objective is to provide high-value, high-impact consulting services in order to enable your business to be simply compliant by doing things better, smarter, leaner and in a more cost-effective way.
The key components that are blended to provide you with a tailored service of consulting, implementation and knowledge transfer designed to meet your business needs.
- Strategy – Identifying and advising on best practice for you and your business
- Implementation – Tactical implementation and delivery of lean compliance and improvement
- Knowledge Transfer – training and empowerment of your team
This methodology forms the foundation of the Veracord approach.
Since 2007, Veracord has successfully delivered over 300 projects to a diverse range of clients, from start-up groups through to the world’s leading Life Science industry companies. All projects are delivered using our established process and methodology to achieve success, irrespective of size of project or scope of work.
- Appraisal – understand the full scope of work and the fundamental business, quality and compliance drivers
- Risk Assessment – determine what the assignment must achieve and eliminate any non-value adding activities
- Action Plan – working with you to establish the deliverables, roles, responsibilities and timings needed for success
- Delivery – managing the assignment to achieve its objectives, monitoring and measuring performance
Veracord works with you to evaluate and interpret federal regulations as they apply to specifically to your organization and your systems, and to achieve, document, and maintain compliance.
FDA GxP and Quality Regulations, including (reference 21 CFR):
- Part 11 - Electronic Records; Electronic Signatures
- Parts 50, 54, 56 - Good Clinical Pratice (GCP)
- Part 58 - Good Laboratory Practice (GLP)
- Parts 210, 211, 606 - Current Good Manufacturing Practice (cGMP) for Pharmaceuticals, Blood Products, and Biologics
- Part 820 - Quality System Regulation (QSR)
FDA and Industry GxP and Quality Guidances, Standards, and Good Practices:
- FDA Guidances for Industry (Quality Systems Approach to Pharmaceutical CGMP Regulations, Part 11, Electronic Records; Electronic Signatures - Scope and Application)
- ISPE GAMP Guide and GAMP Good Practice Guides (Testing of GxP Systems, Validation of Laboratory Computerized Systems)
- ICH Quality Guidelines (Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q9: Quality Risk Management)