Quality Remediation Support

Quality Remediation Support

Project Management for a Biotech Client.

PSC Biotech® provided quality remediation support for a Biotech client.  

  • Area: Pomona
  • Project Type:Quality Remediation 

About this Project

OBJECTIVE

The objective of this project was to migrate the data from master control to Veeva and Laboratory Management System (LMS) implementation. 

SERVICES

PSC Biotech specialists supported the client by migrating the data from Master Control to Veeva ensuring data integrity. We also helped the client migrate training records and set up the curriculum. In addition, we also provided insight and timeline on the electronic document management system (EDMS) and reviewed validation deliverables on the data migration. We assessed potential destination systems for the migration and managed integration tasks of the master control training record migration into LMS success factor and provided resource loading for clients on specific tasks.  

PROJECT SUCCESS

The project was completed, and the client was satisfied with the achieved goals. The project success was recognized by the quality assurance (QA) and the executive team members.  

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Quality Document Review

Quality Document Review

Quality Document Review at a large Biotechnology Manufacturing company

PSC Biotech® provided quality assurance and documentation review services for the client at the facility. 

 

About this Project

OBJECTIVE

The project’s objective was to provide support to the Quality Engineering (QE) department. 

SERVICES

PSC Biotech supported the client with Quality Assurance (QA) and document review for the projects and manufacturing procedures. Our work and procedures met company and regulatory standards. A few quality issues were identified, which were resolved by our team. We also reviewed documentation to maintain a validated state of equipment. Lastly, we also partnered in maintaining the database for nonconformances and Correction and Preventive Actions (CAPAs) to provide extra support for the plant directors. 

Project Success

The client has been ecstatic with the work that PSC Biotech expert team has provided for their team. The team has continuously stated that our experts have been an asset to the team throughout the project. 

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Temperature Controlled Chamber Qualification

Temperature Controlled Chamber Qualification

Temperature Controlled Chamber Qualification 

PSC consultants performed qualification protocol and summary generation, and qualification execution.

 

  • Area: Orange County, CA
  • Project Type: CQV and Metrology

About this Project

OBJECTIVE

To qualify multiple refrigerated trailers for controlled-temperature storage.

SERVICES

PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping. PSC consultants performed the calibration, ran engineering studies, wrote and executed qualification protocols, resolved deviations, and closed out reports. 

  

Equipment Used

Project Success

PSC consultants engaged quickly with client needs, adapted to shifting priorities, and delivered trailers to meet client-controlled temperature storage requirements. 

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Auditing – Quality Systems and Records

Auditing – Quality Systems and Records

Auditing – Quality Systems and Records

Perform Supplier Audits to assess the quality systems and records

  • Area: British Colombia – Vancouver and Victoria
  • Project Type: Auditing

About this Project

OBJECTIVE

Perform Supplier Audits in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices. 

 

SERVICES

This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. The PSC Biotech® Services Project Manager and Senior Supplier Auditor worked with the client’s Quality team to ensure that the client’s specific quality concerns were incorporated into the supplier audit items and process. This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control “. The PSC Biotech® Services Project Manager and Senior Supplier Auditor worked with the clients Quality team to assure that the clients specific quality concerns were incorporated into the supplier audit items and process.

PSC® appointed a Project Manager and a Senior Supplier Quality Auditor who successfully developed and maintained a supplier audit schedule in consultation with the client quality team. Audits were scheduled with vendors and executed as planned. Audit reports were issues, audit responses and corrective action and preventive action follow-up status and closeout reports were provided to the client.

PROJECT SUCCESS:

The project was a success, and the company is still a client of PSC®.

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Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment Project

PSC® Biotech’s professional services group to perform comprehensive Gap Assessment on Cleaning Validation.
  • Area: Toronto, Ontario
  • Project Type: CQV

About this Project

OBJECTIVE

Perform Cleaning Validation Risk Assessment   

SERVICES

This client utilizes PSC® Biotech’s professional services group to perform Gap Assessment on Cleaning Validation on their manufacturing equipment to maintain regulatory compliance and expectations. PSC® validation engineers evaluated the appropriate records, performed a gap analysis, and identified areas for continuous improvement. Remediation tasks were associated with each of the findings and combined into a comprehensive quality risk assessment document.

PROJECT SUCCESS

The project was successful, and PSC Biotech maintains an ongoing partnership with this client.  

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