Calibration Services

Best-in-Class Calibration & Validation Services that Enhance Integrity & Reduce Risk

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 ensure your facility stays GLP, GCP, or GMP compliant.

We will serve as your trusted partner and advisor and utilise our long-standing track record to help you meet the requirements and standards set by worldwide agencies. Furthermore, our Metrology Unit offers the following range of services to assist you:

Equipment Validation Services:

  • Review and preparation of validation master plans
  • Gap analysis and risk / impact assessments
  • Qualification and validation, including validation plans, design, installation, operational and performance qualifications
  • Support for the implementation of a remediation program
  • Equipment commissioning (factory and site acceptance tests)

Instrument Calibration Services:

  • Metrology plan review and preparation
  • Field instrument calibration
  • Reference instrument calibration in our accredited laboratory (LAT n.200)
  • Calibration of instruments measuring humidity and temperature at our Center LAT n. 200, according to the operating range and uncertainty accredited by ACCREDIA

Process and Quality Support

  • Third party and supplier assessment, qualification and auditing
  • Remediation plan management
  • Manufacturing process optimization and validation
  • Risk and gap analysis support
  • Cleaning process development and validation
  • Technology transfer support
  • Regulatory support for the preparation and upgrade of document types, including Common Technical File (CTD), Technical File (TF), and Drug Master File (DMF) types
  • Processes and primary packaging validation
  • Inspections and audit preparation
  • Annual product reviews
  • GMP support (i.e. variations and deviations management)
  • Internal processes analysis to improve the efficiency and efficacy of the company

Information Technology Compliance and Validation:

  • GxP risk assessment and remediation plan management
  • Computer system validation (GAMP v.5)
  • 21 CFR part 11 compliance support and verification
  • Support for IT infrastructure management and IT networks qualification

Safety, Quality and Environmental (SQE) Protection Support:

  • Workplace risk assessment reports
  • Emergency plan
  • Single document on the assessment of risk from interference (DUVRI)
  • Risk assessment of exposure to mechanical vibrations
  • Preparation, support and implementation of measures for protection and prevention
  • Noise impact assessment
  • External management for head of the prevention and protection department
  • Fire protection and prevention management
  • Support for drafting the explosion protection report
  • Work supervision
  • Project design and work coordination

What Our Clients are Saying

“I just want to express my appreciation for your impressive AuditUtopia™ program. During a recent PAI inspection from the FDA we were challenged with 211 requests for documents. I do not know how we would have managed without the AuditUtopia™ software. Our Quality staff was able to execute FDA requests rapidly and flawlessly, communicate in real time between the various groups, and all of this resulting in less stress overall. The inspection was a success. We received our commercial license, and AuditUtopia™ was a big part of achieving that milestone.”

“This is to certify that PSC Biotech (PSC) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia™ has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia™ and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”

How Can We Help You?