Welcome to the Accelerator Documentation Center
Transparency and partnership are at the heart of Pall Biotech. We know that the availability of high quality product documentation helps you manage the vast amount of documentation required for regulatory submission. This portal collates all current documentation to help you navigate compliance quickly and efficiently, and the electronic regulatory dossiers help you in your ongoing risk assessments to help alleviate the pressures of preparing documentation for regulatory compliance and audits.
The Accelerator Documentation Center gives you direct access to the documents you need, for access to the Accelerator Regulatory Dossier just register here.
Regulatory Documentation: Review and download general compliance statements and product specific regulatory documents.
Quality Documentation: Access and download Pall’s essential quality documents, ISO certifications, supplier information, and safety data.
SME Corner: Access prior knowledge from our Subject Matter Experts (SMEs) as well as perspectives relating to regulatory and compliance-focused ‘hot’ topics. The current categories include:
∙ Approach to Sterility
∙ Extractables and Leachables
∙ Integrity of Single-Use Systems (SUS)
∙ Pre-use Post Sterilization Integrity Test
∙ Particles Management
∙ Change Management
∙ Industry Interest Groups
∙ Integrity Testing
∙ Sterile Filter Validation
To learn more from our Subject Matter Experts take a look at the available articles here.
Resources: Links to webinars and other informative web pages, including external links to industry groups, white papers and relevant standards
Using this Accelerator Documentation Center, you can also request a product batch certificate or file your complaints and track the advancement of the investigations.