PharmaSys Services   

PharmaSys combines proven experience in system compliance and validation with extensive knowledge of scientific and laboratory processes. 

• Audits - PharmaSys provides third party cGMP, GLP and GCP compliance audits as well as computer validation readiness and Part 11 compliance audits.

• BE/BA Study Audits - PharmaSys provides third party audits of clinical study laboratory data for bioavailability and bioequivalence studies in support of Abbreviated New Drug Applications (ANDAs) and New Drug Application (NDAs).

• Automation Systems - PharmaSys provides validation services for all types of automation systems.

• Cleaning Process Development & Validation  for bulk chemical, solid dosage and non-sterile manufacturing areas/equipment.

• Clinical Systems - PharmaSys is recognized as a world leader in clinical system compliance and validation. We provide education on the special needs for validation of clinical data systems and have several staff members who have given international lectures on Clinical Systems.

• GMP Facilities Commissioning and Qualification services for new construction, expansions, up-fits and modifications. We also provide remediation for facilities not meeting current standards.

• Compliance Services

  PharmaSys provides general compliance services by developing standard operating procedures, developing QC sampling programs, developing validation programs and performing audits.

   

• Computer Validation

  PharmaSys has provided computer validation services to a number of world class pharmaceutical and biotech companies and can deliver that same world class service to your company.

   

• Equipment Validation

  PharmaSys can assist your company with equipment qualifications, provide a turn-key solution for initial validation in preparation for pre-approval inspections or provide revalidation services.

   

• Laboratory Systems Validation  for stand-alone and networked laboratory equipment.

• Process Validation  for initial validation in preparation for pre-approval inspections,  revalidation services and annual product reviews.

• Thermal Validation

  PharmaSys provides world class thermal validation services to a number of international pharmaceutical and biotech companies and can deliver that same world class service to your company.

• Scientific Process

  PharmaSys combines proven experience in system compliance and validation with extensive knowledge of scientific and laboratory processes.

Deliverables

PharmaSys can deliver complete turn-key validation packages to the client or provide assistance in any phase of a validation project. Examples of our deliverables are:

• Quality Assurance/Validation Master Plans
• Functional Requirements Specifications
• Detailed Design Specifications
• Installation Qualifications
• Operational Qualifications
• Performance Qualifications
• Process Qualifications
• Testing Execution
• Summary Reports
• SOPs, Guidelines, Audits

Key Benefits of Using PharmaSys
for your Validation Needs

PharmaSys can supplement your company's validation and compliance staff or provide complete turn-key validation projects with our considerable expertise in pharmaceutical systems validation and manufacturing technology.

PharmaSys provides validation services for special projects such as implementation of ERP/Information Systems, plant expansions and line extensions. Your staff can concentrate on running your business rather that dealing with outside distractions.

PharmaSys provides your company with validation expertise if you don't currently have that capability.

PharmaSys helps you meet aggressive timelines by providing expert supplemental resources.

PharmaSys also provides QA audit and watchdog services for projects in which other firms have been contracted to complete commissioning, validation and/or turn-key implementations. In these situations, PharmaSys personnel will provide compliance expertise and QA on activities and review all resulting documentation for FDA and other regulatory agency compliance.

PharmaSys provides highly qualified resources for your needs and provides technical support to those resources. When you hire a PharmaSys professional, you hire the resources of the entire company.

PharmaSys is normally the lowest cost provider of services. When compared to the industry average, PharmaSys usually saves clients 15% over competitor's costs while maintaining 100% commitment to services.

PharmaSys does not cut corners. Because most of our personnel have worked in the industry and have had to defend validation documentation to the FDA, we know how important complete, well-organized documentation is to the process. We work hard to provide well-documented protocol rationale and use good data collection practices.

PharmaSys stays abreast of current validation and compliance issues by speaking and attending training and industry conferences promoted by organizations such as DIA, ISPE, PDA, Interphex, ASQ and others.

Several PharmaSys personnel are considered industry experts in their respective fields and have provided numerous lectures on validation.