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Services
PharmaSys provides the following services:
PharmaSys combines proven experience in
system compliance and validation with extensive knowledge of
scientific and laboratory processes.
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Audits
PharmaSys provides internal audits of overall quality systems, computer information systems, automation systems and validation programs.
- Automation Systems
PharmaSys provides validation services for all types of automation systems.
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Audits of Bioavailability and Bioequivalence Studies and Contract/Clinical Research Organizations
PharmaSys provides third party audits of contract research organizations, as well as of clinical study laboratory data for bioavailability and bioequivalence studies in support of Abbreviated New Drug Applications (ANDAs) and New Drug Application (NDAs).
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Cleaning Systems
PharmaSys provides cleaning validation services for bulk chemical, solid dosage and non-sterile manufacturing areas/equipment.
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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.
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Commissioning Validation
PharmaSys provides commissioning and facilities validation for exiting facilities, newly constructed facilities and for facility upgrades.
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Compliance Services
PharmaSys provides general compliance services by developing standard operating procedures, developing QC sampling programs, developing validation programs and performing audits.
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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.
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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.
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HIPAA
PharmaSys provides HIPAA training and audits in order to comply with government and internal regulations.
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Laboratory Systems
Pharmasys provides laboratory systems validation for stand-alone and networked laboratory equipment. PharmaSys can also provide remediation for existing or new equipment.
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Process Validation
Pharmasys can assist your company with process qualifications, provide a turn-key solution for initial validation in preparation for pre-approval inspections or provide revalidation services as well as process qualification protocols. PharmaSys can also develop applicable operational, maintenance and 21 CFR 11 SOPs in support of the validation project.
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Sarbanes-Oxley
PharmaSys provides testing, assessment and validation of financial systems, in particular the assurance of computer systems and applications, in order to comply with government and internal regulations.
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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.
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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:
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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.
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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.
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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.
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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.
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Several PharmaSys personnel are considered industry experts in their respective fields and have provided numerous lectures on validation.
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