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When one of our clients struggled with enough talent to fulfill a broad remediation plan they promised the FDA, they turned to Compliance Architects®. After quickly scoping their needs and factoring in the company’s “personality” we were able to select the perfect individual to work hand-in-hand with their staff. In short order our colleague provided the following:

• Represented their needs, requirements, and objectives in the workstreams for deviation management, CAPA and change control.
• Reviewed and provided invaluable feedback on workstream outputs, including standard operating procedures, metrics, and their training material.
• Provided updates to program leadership regarding the delivery plans and schedule for these workstreams and helped program leadership evaluate how well requirements and objectives were being met.
• Supported executive leadership with establishing and maintaining appropriate governance forums (e.g., CAPA Review Board), and supporting activities related to these forums.

Migrating to a new software system is always a tough project. Get it right and you’re a hero. Make a mistake and you’re deemed a failure. Through a referral, Compliance Architects® was introduced to a new client that desperately needed a change management AND communications executive. That’s not an easy person to find and place on a project. But after a detailed needs analysis, Compliance Architects® was able to find just the right person to lead this Trackwise project to success. In a matter of months, our consultant:

• Developed and managed communications plans, content and materials and distributed communications to business partners.
• Worked through change management opportunities, benefits analysis and supported key users/stakeholders through significant changes.
• Developed materials for Project Go-Live and the boots-on-the ground implementation of the programs.
• Provided support in creating and updating communications content and organizing in SharePoint, Microsoft Teams.

Having a significant backlog of CAPAs across 3 manufacturing sites and the home office is a huge red flag for the FDA. But that’s what a client had when they called us and asked for help. Tapping into out talent database, Compliance Architects® was able to quickly pull together a CAPA support squad to help this client get back on track. Our experts made sure to:

• Drive individual CAPAs to completion at each of the three manufacturing sites and home office.
• Rationalize CAPAs that were initiated against other structured, documented programs, to identify and correct redundancies.
• Assist individuals and teams to get CAPAs driven to completion, and to help bring the numbers of open CAPAs to acceptable levels going forward.

Nothing can get out of hand faster than non-conformances and poor root cause analysis/failure investigations. Knowing they had serious problems, Compliance Architects® was retained by a global pharmaceutical manufacturer to provide a team of experts to:

• Developed and managed communications plans, content and materials and distributed communications to business partners.
• Worked through change management opportunities, benefits analysis and supported key users/stakeholders through significant changes.
• Developed materials for Project Go-Live and the boots-on-the ground implementation of the programs.
• Provided support in creating and updating communications content and organizing in SharePoint, Microsoft Teams.