Our team has extensive experience with 21 CFR Part 11 in the GxP areas.
We are offering services in:
Training in 21 CFR part 11 for management and technical personnel.
Consulting services in new risk based analysis, electronic data, electronic signatures and retrospective validations. Evaluation of GCP, GLP and GMP related programs and systems.
Evaluation and development of 21 CFR Part 11 compliance policies and procedures.
Documentation for compliance issues.
Developing validation packages including requirements, specifications, manuals, SOPs and training documents.
Validation protocols and configuration of best practices.
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