Audit Services

i) USFDA(21 CFR Part 820) Mock Audit
ii)ISO 9001 &ISO 13485:2003/EN ISO 13485:2012 Mock Audit
iii) VENDOR MANAGEMENT /SUPPLIER QUALIFICATION Audit
iv) GMP Mock Audit as per Schedule M and WHO requirements.

Computer System Validation(USFDA 21 CFR Part 11)

The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. CDAQI team have experience with computer system validation activities and provide services as per customer needs.

CDAQI will guide you in the following aspects:

21 CFR Part 11 Regulatory Documents
21 CFR Part 11 Electronic Records and Signatures
Guidance for Industry: Part 11: Electronic Records; Electronic Signatures – Scope and Application
General Principles of Software Validation; Guidance for Industry and FDA Staff
Off-The-Shelf Software Used In Medical Devices
Key Concepts About 21 CFR Part 11, Electronic Records and Signatures

Ut dignissim, urna ac tristique condimentum, nibh massa pretium orci, vel accumsan dolor elit nec erat. Vestibulum posuere, nunc a pretium tempus, nisi justo adipiscing justo, vitae interdum dolor risus ac lacus. Etiam a molestie lacus. Proin aliquet elementum turpis, et accumsan nisl sempera.

Sed quis justo ipsum. Proin placerat nibh mauris, in posuere risus viverra vel. Aliquam ac dapibus ante. Cras luctus mollis est, sed fringilla magna blandit eget. Sed ac nunc arcu. Maecenas in pretium nunc. Aenean scelerisque tellus vestibulum, laoreet ipsum quis, accumsan velit. Ut dignissim, urna ac tristique condimentum, nibh massa pretium orci, vel accumsan dolor elit nec erat. Vestibulum posuere, nunc a pretium tempus, nisi justo adipiscing justo, vitae interdum dolor risus ac lacus. Etiam a molestie lacus. Proin aliquet elementum turpis, et accumsan nisl sempera.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>

clear formSubmit