Compliance

The Approach.

Compliance done right is a blend of regulatory awareness, common sense and science.   With ValSource you can reach and sustain the right level of compliance with all U.S. and global compliance expectations, requirements, and trends.  When needed, we can offer a partnership of capabilities.

Compliance fails when there is complacency and misinterpretation.  Fixing the obvious is not always enough.  ValSource Quality Risk Management Consultants and Compliance Consultants can bring experience and a unique level of awareness, allowing you to create and defend the risk and science based positions, global health authorities are seeking.

Where technical and scientific answers to process control are needed, Valsource Process Validation, Environmental Monitoring, Aseptic Processing, and Microbiology Consultants help you find the right answers, conduct the right studies, analyze the applicable data, present and defend the answers.

Developing the culture to recognize and address root cause needs, is the answer to sustained compliance.  Combining knowledge and awareness with the training from ValSource Learning Solutions, leveraging a variety of organic, evidence-based learning approaches, fosters the communication needed to develop that sustaining compliance culture.

Without the proper infrastructure, compliance will not be sustained and failures likely be repeated.  ValSource Quality System Consultants help you identify and build the right Quality System for your company, organization, and products.

Finally, sound, practical recommendations must be implemented in a practical and effective manner, consistent with your business plan and resources.  ValSource’ Program Management, Commission and Qualification, and Safety help you plan, manage, procure, qualify, validate, and operate a complaint and reliable operation.

Rapid Response Team

ValSource’s Rapid Response Team is and does exactly what the name implies. The team is a fast action, fast response team, developed to quickly, efficiently and seamlessly respond to the needs of clients requiring immediate address of regulatory and compliance citation matters.

The Rapid Response Team approach is proven effective. It encompasses senior consulting support and knowledge team leadership in microbiology, contamination control, process control, system and process validation, data integrity, training, quality risk management, and overall quality system development and implementation.

The knowledge tools and solutions we deliver simplify complex issues, fostering and transferring knowledge to increase client self-sufficiency. Where possible, we work closely with all relevant technical personnel and managers.

The Rapid Response Team reviews technical and regulatory materials, presenting findings and data via approved vehicles and platforms to address regulatory concerns, microbiological procedures, data management, acceptance criteria and responses to Health Authority questions.

The Pains.

Delays in product approvals and market introduction.

Product failures, defects, delays in batch release, drug shortages.

Regulatory citation, recalls, lost productivity, lost reputation, cost of corrections.

Document confusion, inadequacy, poorly communicated regulatory filling response.

The Relief.

Product success and optimal quality healthcare.

Products reach market on time.

True compliance solutions.

Ordered, appropriate, comprehensive, clear, document language.

Clearly articulated regulatory filings, submissions and responses.