ACD/Labs provides compliance-ready software for use in both GxP (good laboratory practice—GLP, good manufacturing practice—GMP) and CFR21 Part 11 compliant environments. We have supported numerous customers through the complicated process of validation and managed successful software audits.
Compliance for laboratory software systems means consistent and reliable results to assure quality, traceability, integrity, and validity.
How we do it
Software on the ACD/Spectrus Platform has been designed with features necessary for regulatory compliance. We can help with installation of our software and solutions in regulated environments and are happy to provide an advisory level of support based on our experience.
Validation
- A quality management system (QMS) and processes are in place for self-directed software validation.
- We can assist with the creation of Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) scripts.
GxP Compliance features in Spectrus® Software:
- Audit trail with date and time stamp, description of the change, and the name of the person making the change
- Specific user accounts
- Forward compatibility of files generated by the software
- Data storage in a secure database environment with protection against tampering
CFR21 Part 11 Compliance
CFR21 Part11 compliance is necessary when you are sending electronic information directly from ACD/Labs software to regulatory authorities
- Electronic signatures