Products by PSC Biotech Corporation
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When you work with PSC Biotech, you can expect a seamless, FDA and EMA compliant, customized solution to all your computer systems validation needs. With over two decades of consulting experience in the life science industry, we fully understand that computer systems are a key element of a... Read more »
PSC is one of the largest providers for Commissioning, Qualification, and Validation services for the life science industry. Our team consists of seasoned experts in the validation of facilities, utilities, equipment, computer systems, processes, cleaning, and test methods. We provide end to end... Read more »
All team members are trained in Quality at PSC. We focus on compliance, quality systems and methods, audits, and product and process control and design. Our Quality Engineers specialize in QA Oversight, Gap Analyses, Training Compliance and Support, Review and Approval of Validation Documents,... Read more »
At PSC, we know how critical documentation is; that is why our team of skilled Technical Writing experts are trained in Good Documentation Practices (GDP). We are experts in drafting, editing, and reviewing technical documents, such as protocols, summary reports, specifications, SOPS, and... Read more »
PSC Biotech® experts have extensive knowledge and experience with the submission of Global Regulatory Documents. We provide all highly regulated industries with pre-market and post-market activities for global life science submissions. You can turn to our experts to ensure a timely approval of... Read more »
The PSC Biotech™ Metrology Unit is a test equipment laboratory and pharmaceutical validation service with experience and skill in serving the life science industry both in the United States, as well as, abroad. We are capable of providing equipment validation and instrument calibration that will... Read more »
Engineering services for the Life Sciences is a key area of expertise for PSC Biotech. We provide engineering support, engineering drawings, engineering SOPs, redline P&IDs, support Preventative Maintenance and Product Specifications. We also provide Certification Programs for capital projects... Read more »
Our team of project managers have a strong track record of delivering projects and providing solutions for the life science industry. Our team follows the Project Management Institute’s Best Practices and ISPE’s Good Practice Guide: Project Management for Pharmaceutical Industry, and tailor this... Read more »
PSC Biotech® has extensive experience in auditing GxP companies – from assisting companies with an upcoming pre-approval inspection to third-party suppliers and testing facilities. Our staff of seasoned professional auditors has experience with the FDA, ISO, and international regulatory agencies. Read more »
Adaptive Compliance Engine® (ACE®) is a cloud-based software solution used to accelerate your companies quality processes. It’s a quality management system that allows companies like yours to automate, transform, adapt and grow to meet your evolving quality management needs without coding. With... Read more »
ACE Essentials™ is our EQMS software is created for all highly regulated industries. This EQMS comes equipped with all the necessary Standard Operating Procedures (SOPs) so you have a fully compliant quality management system from day one at an unbeatable price. With ACE Essentials™ includes... Read more »
In highly regulated industries, you can count on the fact that your company will be inspected a time or two. AuditUtopia® captures, tracks, communicates, and sorts audit activities as a real-time Inspection Audit Management System used to host inspections and audits that is trusted by life... Read more »
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