Helping Companies Reach Compliance Goals Since 2005

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Case Studies

case-studiesTicalion has worked with and helped many outstanding companies since 2005. Following is a snapshot of some of our work.The scenario
Unisys Corporation successfully acquired the American Red Cross as a datacenter client. More than 500 servers and peripheral devices supporting 510K registered, Class II and Class III medical devices needed to be moved out of the prior service provider’s datacenter and into the Unisys data center within a 6-month period. A quality management system supporting regulated activities was required to be implemented as well as passing a supplier qualification audit with zero observations (pass/fail) for the project to be able to move forward.

The challenge
1. Months 1 – 3: Design and deploy a new quality system that is compliant to the USFDA quality system regulations on a project scale that would integrate with the existing ISO quality system that is in place corporate-wide at Unisys. American Red Cross could not qualify Unisys as a supplier without the quality system being in place prior to contract execution. The supplier audit was a pass/fail audit with no opportunity to redress observations. Any failures in the quality system would have caused Unisys to lose the contract immediately.

2. Implement controls for compliance to the American Red Cross consent decree and the quality controls that were specified in the Unisys/American Red Cross contract.

3. Months 4 – 6: Validate the Unisys datacenter environment and equipment that would be used to service the American Red Cross in preparation for the move of equipment into the datacenter. The datacenter move could not be delayed since the equipment needed to be moved from a prior vendor and would no longer be serviced by that vendor once their contract expired.

4. Months 6 – 9: Transition over 500 servers and peripheral devices supporting 510K registered, Class II and Class III medical devices from one data center to another with no service disruptions to the American Red Cross operations and produce documentation supporting the continued validation and registration of the equipment.

The solution
1. Ticalion provided dedicated personnel to develop and oversee quality system design/deployment, trained Unisys personnel in regulatory compliance, managed the quality system and performed all quality assurance operations.

2. Ticalion authored the quality manual, quality plan all quality assurance department SOPs and developed the validation program, procedures and forms including authoring the validation master plan for the data center validation, server and peripheral device post move qualifications, and authored the validation master plan supporting the validation of the ITSM Remedy system.

3. Within 18 months, Ticalion transitioned management of the quality system entirely to Unisys.

The scenario
NuGen, Inc., a small reagent manufacturer servicing the pharmaceutical industry, seeking ISO 13485 registration.

The challenge
Client’s desired target date for ISO registration audit was 6 months.

The solution
Ticalion assessed the company’s existing processes and procedural documentation, performed a GAP analysis to ISO 13485, and worked with NuGen personnel to remediate deficiencies. The solution included validation of the temperature monitoring system, which had not been validated when the system was installed.

The scenario
Johnson and Johnson acquired DePuy Orthopedics and Synthes.  All entities had their own quality systems.

The challenge
Identify global affiliates of all three companies  that required intra-company quality agreements and put quality agreements in place.

The solution
Ticalion created a work instruction and template to facilitate the creation of the quality agreements and managed the CAPA that was raised for the activity, which identified global affiliates in 210 countries that were candidates for quality agreements and 14 intra-company relationships that were candidates for quality agreements. Ticalion implemented quality agreements for the identified relationships to the customer’s target completion goal.

About Ticalion Quality Management Services
Ticalion provides expert quality system deployment and remediation services to meet requirements for FDA compliance and ISO registration.