In many laboratories, the need for stringent documentation of quality control and assurance becomes more and more relevant. We estimate that at least 10% of all samples tested in the pharmaceutical industry must be run according to GLP. Furthermore, GLP compliance is a prerequisite for many accreditation efforts.
TSE Systems can assist your GLP compliance by providing the following:
- GLP compliance software: for example, no access to raw data; audit trail; user manager; etc.
- Manufacturer ISO certification
- Clarification of validation documentation supplied
- Drafts of SOP documents
- Archived validation documentation (15 years)
- GLP calibration certificates
- Parts traceability
- Validation documentation and on-site performance including installation qualification, operation qualification and Daco software validation
Speak to your local representative for further details or use the contact form.