computer validation

Featured Services

GMP & Quality System Services
Validation Services
Computer Systems Validation
Regulatory Affairs & Compliance Services
Due Diligence

Services we offer

  • GMP & Quality System Services
  • Validation Services
  • Computer Systems Validation
  • Regulatory Affairs & Compliance Services
  • Due Diligence

    • Companies Served

  • Pharmaceuticals
  • Biological
  • Clinical
  • Research
  • Cosmetics
  • Food
  • Medical Devices
  • Natural Health Products
  • Nutraceuticals

    • We Offer

    compliance services
    GMP & Quality System Services
    We provide professional services, consultation and training in the following Pharmaceutical and Biotech Quality areas:
    GMP Audits; Quality Systems; Manufacturing; Lab and Analytical Methods; Remediations- 483s and Health Canada Observations
    Gap Analysis and Remediation; Deviations and Incidents; Failure Investigation; CAPAs; Complaint Handling and Recall
    CMC Change Management; Batch Production Records; QA Release; SOPs and Documentation; ISO 13485 and ISO 9001; Risk Assessment
    Inspection Readiness; Validation
    gmp
    Validation Services
    It Includes:
    Water System Validation; Equipment Validation; Facility Validation; Utilities Validation; Analytical Method Validation
    We prepare strategy include: Audit; Development of Validation Master Plan (VMP); IQ, OQ and PQ Execution; Protocol and Reporting; Development of internal auditing system with respect to Validation services.
    process validation
    Computer Systems Validation
    CSV Audit - A Subject-based readiness analysis
    CSV Strategy - strategy tailored to your processes, organisation and IT and automation landscape with equal focus on cost factor. This risk based approach will help you to carry out validation projects faster and with significantly lower outlay.
    CSV Implementation - Our consultants will support your validation projects in a variety of roles e.g. Project MAnager, Validation engineer, Complaince Auditor.
    process validation
    Regulatory Affairs
    We provide professional services, consultation & training in the following sectors: Drug Products; Biologics; Medical Devices; Natural Health Products Veterinary Products; Nutraceuticals; OTCs; Cosmetics; Food Products Disinfectants; Pesticides; Consumer and Personal Care; API(Bulk Pharmaceuticals)
    process validation
    Due Diligence
    GAP Analysis and REmediation; Remediations - 483s; Health Canada/FDA Observations; Deviations and Incidents; Failure Investigations; CAPAs

    Computer System Validation Includes:

    1
    CSV Audit
    We audit using a standardized method, taking international requirements into account. You decide which area we should audit. For example, an audit for preparing an official inspection can therefore be carried out, (e.g. FDA) or a subject-based readiness analysis, e.g. 21CFR 11.



    2
    CSV Strategy
    A good CSV strategy is tailored to your processes, your organisation and IT and automation landscape. We start by identifying the current situation with the help of a standardised method, e.g. reality check (link) and will identify the organisational and technical measures particular to your requirements. In consultation with your experts we will develop a validation strategy that will satisfy the requirements of the authorities and your customers for the long term. Equally, the focus is on: the cost factor. The aims of the strategy are not only to meet requirements but equally to implement the validation tasks economically. The risk-based approach will help you to carry out future validation projects faster and with a significantly lower outlay. As an additional benefit for suppliers of machines and equipment, you are able to offer a standardised validation package that is considerably below previous costs. This service is required more and more frequently when purchasing machines and will therefore significantly increase your market opportunities.





    3
    CSV Implementation
    Our consultants will support your validation projects in a variety of roles, e.g. as a project manager or as a validation engineer. The experience of our CSV consultants in validating computerised systems goes back several decades and encompasses all IT, laboratory and automation systems. We know the dangers and sources of error during implementation only too well. Benefit from our expertise and avoid the mistakes made by others in the past.