OUR PROJECTS
Our Service Related Projects
PAST PROJECTS
PAST PROJECTS
Project Summary, Technical Writing
Oct 21, 2020
Technical Writing | Conducting Investigations & Resolving Nonconformance’s
Provided technical writing services. The scope of technical writing to be provided included: Lot release- was actually researching errors and inconsistencies in existing records. Also generated SOP’s for equipment facilities and utilities.
Project Summary, Technical Writing
Oct 21, 2020
Technical Writing | Researching Errors & Inconsistencies In Existing Records
PSC‘s® technical writer for this project primarily wrote, edited, and reviewed cGMP documents, Systems Specifications, SOPs, and related materials while maintaining standardized documentation practices for recording details of new processes.
Project Summary, Technical Writing
Oct 21, 2020
Technical Writing | Engineering Projects & New Equipment Implementation
PSC provided the Texas facility with technical writing support for engineering projects and new equipment implementation. Documents included Functional Risk Assessment, System Risk Assessment, Standard Operating Procedures, Work Instructions, Traceability Matrix, User Requirement Specifications, and Functional Requirement Specifications.
Project Summary, Technical Writing
Oct 21, 2020
Non-Medical Technical Writing Support Project
PSC® provided the client with non-medical technical writing support including Data Science and Regulatory Affairs focused, a Pharmacovigilance process improvement initiative, and other Clinical Science process improvement efforts.
Project Summary, Technical Writing
Oct 21, 2020
Technical Writing | Validation & Compliance For Computerized Systems
PSC® provided Validation and Compliance Technical Writing for the transition of computerized systems for the client. Responsibilities included but were not limited to generation, re-visioning and execution of the following SDLC validation documentation: Compliance Analysis, Compliance Plan, User Requirements, Functional Requirements, Test Protocol, Test Execution, Traceability Matix, and Compliance Report of the computerized systems.
CSV, Project Summary
Oct 21, 2020
CSV | Remediation Validation & Compliance Project Management Project
This project is a remediation Validation and Compliance Project Management for the transition of computerized systems from the previous system.
CSV, Project Summary
Oct 21, 2020
CA+Ireland Full Spectrum Projects
PSC® executes approximately 40 CSV projects per annum across the full spectrum of systems (bench-top instruments through enterprise applications such as ERP, DCMS, and QMS.
CSV, Project Summary
Oct 21, 2020
CSV | CRM & Vault Modules Projects
PSC® has provided the client with cross-regional support in California, Ohio, and Canada. These projects have focused on the clients CRM and Vault modules(QMS, eTMF, Quality Docs, PromoMats, EDC).
CSV, Project Summary
Oct 21, 2020
Commissioning And Qualification Projects
Equipment Qualification, Computerized Systems Validation, IT, QA, Systems Assurance, EDMS, Administration Business Analysis
Auditing, Project Summary
Oct 21, 2020
Assessing The Quality Systems And Records
This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. PSC Biotech® auditors focused the majority of audit time observing the “on the floor” operation at the vendor site.
Auditing, Project Summary
Oct 21, 2020
Global Auditing Of Quality And Manufacturing Systems
PSC® prepared global auditing tasks for this project which required preparing product audit agendas per the clients document requirements, preparing product auditing, performing CAPA follow-ups, conducting onsite finished product types, writing audit reports, and generating product audit findings and report per the companies document requirements.
Metrology, Project Summary
Oct 21, 2020
Metrology | Kaye Validator 2000, Sims, Tc And Drywell
PSC® performed calibration services for Kaye Validator 2000, SIMs, TC and Drywell, are performed in our Metrology Lab. Using the required calibration software, module, and DC voltage source along with the required temperature standards. As well as providing preventive maintenance support for their validation equipment.
Metrology, Project Summary
Oct 21, 2020
Metrology | Temp/Humidity Circular Chart Recorder
PSC® Performs annual on-site metrology for Temp/Humidity circular chart recorder with LCD display used at a controlled warehouse facility. Metrology is preformed by our field technicians using a Vaisala Handheld humidity and Temperature standard Probe, with measurement accuracies of ±1.0%RH and ±0.2ᵒC.
Metrology, Project Summary
Oct 21, 2020
Metrology | Power Scientific Stability Chamber
Annual Metrology is performed for their Power Scientific Stability Chamber. This Chamber maintains temperature and relative humidity (RH) conditions inside. It has an integrated Watlow temperature & RH controllers, with an alarm display, along with a Honeywell Chart recorder.
Metrology, Project Summary
Oct 21, 2020
Metrology | Field & Lab Metrology
We worked closely with Metrology on site to assist with Field & Lab metrology in relation to Temperature, Humidity, Pressure, Mass and Dimensional. Notably field calibrations are Sterilizers using Temperature Standards & Baths, and Pressure Standards. On-site Lab metrology for TCs, Data loggers, Scales, Gauges and Pressure Transmitters. With our services ranging to in house metrology for Kaye Validator 2000, Kaye SIMS and Kaye IRTD Standards.
HOW CAN WE HELP YOU
HOW CAN WE HELP YOU
Contact PSC Biotech® Corporation Today!
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