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Computer
Product and Services Audits |
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Under
21CFR Part 11, computer product and service companies are required
to undergo audits by end users in support of their claims for
compliance and validation required by FDA regulations.
The PDA Technical Report #32 (TR-32) "Auditing of Suppliers Providing
Computer Products and Services for Regulated Pharmaceutical Operations" was
designed to provide companies with a standardized evaluation criteria
and methodology.
Regulatory inspections of how well companies qualify application
software and validate computer systems are assessed on a case-by-case
basis. As stated by the FDA, sound structural integrity is a key
part of computer validation. The PDA provides a standardized audit
process which:
- has been industry-endorsed
- is designed to provide good data to document the level of structural
integrity for purchased software in use in a regulated environment.
- includes a system of quality checks to ensure the accuracy
and reliability of the process
- satisfies all compliance requirements
NOTE: SynTegra employs PDA-certified
auditors with appropriate expertise, to conducts audits. These audits
are validated before placing them in the audit center for secure
sharing by other subscribers.
Aside from conducting computer product and service audits, SynTegra's
online audit resource center offers Pharmaceutical and biotechnology
manufacturers the opportunity to obtain this data (of previously
conducted audits) for a reduced cost.
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