Throughout each phase of the product development and manufacturing lifecycle, life science companies are faced with significant challenges in complying with global and local regulations. Backed by years of experience, Sciformix understands the challenges companies face in keeping up-to-date with on-going regulatory changes while implementing new technologies and maintaining these systems in a compliant state. We support our clients around the world by developing, implementing and executing a validation strategy through establishing programs designed to productively meet cGMP and regulatory mandates. We offer validation, compliance, and innovative technology platforms and services to our clients.
All our customer initiatives are delivered with project management, scheduling and success metrics that monitor compliance and validation project progress. Operating within an integrated team approach, our goal is to minimize risk, while reducing expensive rework at all stages of the validation life cycle. OOur engagements span the planning, execution and management of compliance and validation initiatives, exemplified by the following services:
- Data integrity gap analysis, development and execution of data integrity remediation plans
Risk-based Cloud Computing strategies
- Development of GAMP® / ITIL based IT Quality Management procedures, creating complete IT Quality Management Systems)
- IT Quality Management Systems gap analysis against current regulatory requirements
- Internal audits or external supplier assessments and audits by ISO 9001/90003 trained auditors
- Compliance assessments of applications, systems or infrastructure platforms
- Infrastructure qualification deliverables support
- Risk-based infrastructure qualification plans and reports
- Project validation deliverables support
- Risk-based validation strategies, plans and reports
- Computer system validation
- IS compliance risk assessments
With our sole focus on the life sciences industry, we offer unrivaled yet flexible expertise in IT validation and compliance. Our team will work closely with you and your quality assurance department to ensure that your compliance and validation standards are productively met. Our Reputation is Built on Protecting Yours.
Getting Data Integrity Right in Life Science
Global Life Science companies need a dependable, objective partner to meet the challenges of creating business and technology environments which ensure data integrity. When these companies gain confidence that the needed data integrity processes have been implemented, they can eliminate the worry and risk to their corporate reputation which would result from a negative regulatory finding. Rather, they can position themselves as organizations that consistently and dependably produce quality and safe products for medical consumers. Sciformix is ready to help you do data integrity right. Download information on our Getting Data Integrity Right in Life Science brochure.