GMP COMPLIANT DOCUMENTATION

DEVELOPMENT

Vibraclean-Controlled Environment-decontamination services

Good Documentation Practice (GDP) are key components of GMP compliance.

Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation practices — and your products — meet industry standards and legal requirements for safety, efficacy and product quality.

  • We provide industry complaint documentation for the work that we perform.
  • Our SOP documentation meets the requirements of FDA, Health Canada, PHAC, CFIA and other governing agencies.
  • Vibraclean collaborates with clients and shares SOP documentation to ensure if fits into your organizations templates and best practices.

Our GDP trained staff understand Record-keeping SOPs help manufacturing operations meet their quality standards and risk management standards.

Good documentation practices are also essential for attaining ISO-9001-2015 certification and other industry-specific ISO certifications specific to your industry, e.g. ISO/IEC 17025 (for laboratory testing and calibration standards); ISO/IEC 27001 (for information security management system / ISMS) and ISO 13485:2016 (for medical device manufacturing).

All work is performed under strict [fusion_tooltip title=”A non-disclosure agreement is a legally binding contract that establishes a confidential relationship. The party or parties signing the agreement agree that sensitive information they may obtain will not be made available to any others.” placement=”top” trigger=”hover” class=”” id=””]NDA[/fusion_tooltip] agreements.

Entire room decontamination, or scientific equipment including Biosafety Cabinets, Incubators and Centrifuges, Vibraclean decontamination services will effectively neutralize all contaminants.