The PDA (Parenteral Drug Association) has released Technical Report 32: Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations. PDA has an agreement with an “audit repository” for making software vendor audits available to companies, thus reducing the need for duplicate audits from various companies. Although done for the Drug Industry medical device companies may also find these reports of value.
For more information click on the link provided. Thanks to David Manalan of INQC for this information.
SoftwareCPR keywords: COTS, OTSS, Vendor