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.