Services

Pharmity offers QA Auditing Services, Consultation for Quality Management Systems and Training primarily to the pharmaceutical and biotechnology industries.

Pharmity is a cost-efficient way of bringing current industry practices into your company.

Audits

Pharmity provides auditing services to support regulatory compliance for your clinical development programme, from Phases I - IV.

Good Clinical Practice (GCP) Audit Services
Investigator Site (routine)
Investigator Site (for-cause)
Site Management Organizations (SMO)
Vendor qualification and evaluation
  • CRO
  • Investigational Medicinal Product (IMP) Distribution Centre
  • IMP Warehouse
  • Archiving
  • Translation
  • Interactive Web Response System/ Interactive Voice Response System (IWRS/IVRS)
  • eClinical systems developers
*Remote vendor audits by tailored questionnaire are also offered.
Phase I Units
Pharmacy audits (assessment of compliance with clinical trial Investigational Medicinal Product (IMP) requirements)
Internal Processes
Documentation
  • Trial Master File (TMF) and Archiving
  • Investigator Site File (ISF)
  • Essential document Quality Control (QC)
Data Management

Each audit will start with the creation of a detailed Audit Plan and followed by a comprehensive and confidential Audit Report. An Audit Certificate will also be provided.

If required by the client, involvement in follow-up activities of each audit (e.g. Corrective and Preventive Action (CAPA) review, acceptance, follow-up steps) can be contracted.

In addition to auditing, Pharmity also provides consulting on strategic audit plans design. We can advise in the development of your company audit program to ensure compliance with regulatory requirements. A good audit program will demonstrate adequate quality oversight and management of quality issues.

Computerized Systems Compliance

Computers have become the primary mode to plan, conduct, close-out, analyze and report clinical research. Throughout all stages of product development, computerized systems are utilized by many stakeholders. E.g.: investigators, contract research organizations, sponsors, central laboratories, specialty vendors.

To ensure these computer systems are fit for their intended use, they need to be trustworthy, reliable and accurate.

Pharmity possesses a comprehensive understanding of the regulations, guidances and guidelines, standards and best practices around the use of computerized systems in clinical research. We offer the following services to help organizations to ensure that the computerized systems are fit for their intended use in clinical trial settings and maintain data quality and integrity.

Computer System Compliance Audits
  • Computer System Validation (CSV) Audits.
  • CSV Vendor Audits.
  • Process Audits.
Computer System Compliance Consultancy
  • Gap Analysis versus key regulatory requirements.
  • System Development Life Cycle (SDLC) documentation review.
  • Advice how to bring computer systems into compliance.

Each audit will start with the creation of a detailed Audit Plan and followed by a comprehensive and confidential Audit Report. An Audit Certificate will also be provided.

If required by the client, involvement in follow-up activities of each audit (e.g. Corrective and Preventive Action (CAPA) review, acceptance, follow-up steps) can be contracted.

In addition to auditing, Pharmity also provides consulting on strategic audit plans design. We can advise in the development of your company audit program to ensure compliance with regulatory requirements. A good audit program will demonstrate adequate quality oversight and management of quality issues.

Consultancy

Pharmity can provide tailored and flexible consultancy services.

  • Quality Management System assessment and/or development:
    • Process review and improvement / Gap Analysis/ Process Mapping
    • Policies and Procedures evaluation, development and writing/ re-writing
  • GCP Regulatory Inspection Support (We are experienced with EMA, MHRA, other EU Regulatory Inspectorates GCP inspections):
    • Mock regulatory inspections
    • Pre-Inspection training
    • Evaluation of company’s inspection readiness
    • Inspection set-up
    • On-site inspection support
    • Investigator site preparation

Training

Pharmity can deliver quality training tailored to your organisation and personnel.

The quality of the learning greatly relies on the quality of training, and so the role played by the trainer and the training structure and content is important as it can have a big impact on the result of a course for a learner.

Each course is adapted to the individual client's needs to ensure that industry knowledge is transferred on topics such as:

  • Current regulations (including routine refresher training)
  • Good Clinical Practice (basic and advanced training for sponsor and site personnel involved in clinical trials)
  • Clinical Quality Assurance (CQA) Auditor Training
  • Audit Skills
  • Training for QA personnel
  • Quality System
  • CAPA
  • Archiving requirements for regulatory data
  • Inspection-Readiness
  • Inspection preparation, support and follow-up
  • eClinical Systems. Computer System Validation, SDLC approach
  • Electronic Medical Records (EMR)
  • Data Integrity

All Training courses include training documentation, assessment of training efficacy and Training Certificates.

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