Dear Life Sciences Industry,
As of March 18th, 2020, the FDA suspended routine onsite domestic inspections until further notice in response to the COVID-19 pandemic. The FDA has signaled that they will implement alternative methods in order to continue inspections, including using remote applications. FDA will be releasing a revision to their Inspection Manual to address their remote inspection procedures and requirements.
PSC Software™ recognizes the urgent need to continue both FDA inspections and other audits for our clients allowing your products to progress through the regulatory approval process while maintaining compliance. With this shift in how inspections will be performed, PSC Software™ has developed a new functionality in our industry leading real time inspection management software, ACE Inspection™, to facilitate remote inspections and audits.
ACE’s Virtual Inspection Management functionality, currently slated for release in July 2020, will allow inspectors and auditors to securely and remotely view your records and documents in response to an inspection request record created in the ACE Inspection™ software.
Once the inspection request record has been reviewed and reaches the proper status, ACE Virtual Inspection Management will allow the inspector to view the approved document and limited metadata associated with the document, through an encrypted viewing portal. This portal will have permissions that will give you the ability to:
1. Limit permissions for the Inspector/Auditor, e.g. view only, download or other permissions.
2. Set a timeframe of access for the inspector/auditor to the portal.
3. Limit the metadata that will be visible to the inspector/auditor.
If you would like more information regarding ACE Inspection’s Virtual Inspection Management capabilities, please reach out to PSC Software at firstname.lastname@example.org.
Senior Manager, Business Development