PDA Software Supplier Audit Program

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

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.