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 NDA agreements.