Consulting

Trustworthy data quality can only be established by evidence from validation practices that operate across a system’s life until its retirement from use. Our consultancy services strive to provide that confidence  

Start-Up Services for new organizations, we help establish a quality management system that supports system compliance and common sense validation practices for organizations that are new to the FDA regulated environment. We start with the creation of the quality policy, training and then work towards the validation of the first system with completion of the first IQ /OQ /PQ packages. This first package establishes templates for subsequent system projects.
 

Limited Engagement Validation Services
We are available to lend a helping hand when your own resource are overburdened with multiple systems to validate. We can be called upon to top up the validation training of project teams and share the Quality project management load for specific engagements.

Mock Audits

We perform mock audits to assess the gaps in a system’s compliant state and suggest strategy for its validation. Another mock inspection of the package can give the team an opportunity to practice defending their work. When external suppliers are involved, we can help with the required due diligence audits.

Third Party Validation Services
We can help software organizations develop a strategy for documenting their Software Development Life Cycle (SDLC) at appropriate quality checkpoints in a sustainable way for Agile or more traditional methodologies. We can help IVR and EPRO vendors build and implement a sustainable OQ strategy that will meet the audit requirements of regulated clients. We help data services companies work through their validation obligations as well.

Remediation Programs
Some of our new clients are organizations that have failed an audit, lost business, or just had an FDA inspection with a lot of 483 observations about their systems and e-data handling procedures. These companies now see compliant computer systems as a crucial business need and to implement good validation practices.

Training

Experience has shown that adults learn best when actively engaged with case studies and exercises that illustrate the key concepts being presented. Our webinars, seminars, and day long programs all have case studies based on our industry projects and exercises that take a team approach to discuss and understand regulation, guidance and robust validation practice. Training and materials are customized to the audience, i.e. management, quality assurance, end user system teams, IT data center folks, or software supplier developers and testers.