Identifying issues in
In a typical submission process, pharmaceutical and biotech companies rely on manual methods and decentralized desktop tools to identify issues in PDF files before they are included in the submission package.
Checking that the PDF output meets the detailed HA requirements is highly time-consuming and as with any manual process includes risks.
Risk of non-compliance is a major problem.
Health Authorities' standards include correctly embedding fonts, fast web view optimization, correct bookmarking, accurate hyperlinks, table of contents inclusion and much more.
In a typical submission, where large numbers of PDF files must be verified manually, issues can easily slip through the cracks.
Automating these validation checks earlier in your process allows you to identify issues earlier and significantly reduce the risk of non-compliance.
Automatically validate every PDF is submission-ready.
DocShifter automatically validates every PDF against health authority and other compliance guidelines. This automation ensures that every PDF that will be included in a submission is fully technically compliant, regardless of the application it was created with.
This significantly speeds up document preparation for your regulatory submissions.
Free FDA PDF format specifications checklist
To help you out in your submissions to US FDA, we prepared a free checklist. This free FDA PDF specifications checklist can help you reduce risk of non-compliance in your submission content preparation for FDA.
Some of the PDF checks that can be automatically performed.
Save huge amounts of time in your regulatory submissions: Begin PDF validation earlier.
Reduce the risk of non-compliance by moving technical content compliance earlier (the moment you first generate or receive your PDF) and reduce last-minute stress during publishing (well some of it anyway).
How does automated PDF validation work?
Frequently Asked Questions
PDF validation is the process of checking and PDFs against a set of rules. These rules or guidelines are defined by the health authorities where the products will be marketed. FDA, for example, demands that PDF can not contain security settings such as passwords and all the fonts in the PDF documents should be between 9 – 12 only.
As different health authorities set out different guidelines for compliance, PDF validation is a core process in submissions. Organizations must be sure that the documents they send out comply with the HA guidelines.
DocShifter is able to automatically check PDF files against a set of rules defined by users. If you wish to, for example, check every document against FDA guidelines, DocShifter will compare the PDF properties and a range of issues with the defined FDA guidelines.
In case your PDF files fully comply with the FDA requirements, DocShifter will return a report to inform you of it.
In case some of your PDF files do not comply with the FDA requirements, you can either tell DocShifter to fix them or simply report and communicate this with internal/external stakeholders.
PDF validation rules can easily be defined and updated in case there are any changes to what health authorities/other regulators demand.
Yes of course. We thought you were never going to ask.
There are multiple options:
- Hand-held demos with your own content.
- A dedicated environment that you can use to upload files to. Where you can configure your own workflows.
- On-premise trial installations, so you can test quality and performance within your own infrastructure.
DocShifter subscription pricing is server, volume and functionality based.
To find out more about pricing, please visit our Pricing page and request your estimate.
DocShifter has native integrations with OpenText Documentum, Veeva Vault, Microsoft SharePoint Cloud, Generis CARA, Lorenz Docubridge, File Systems, Dropbox and FTP.
It also supports any other system that allows Web Services API connections, such as IBM Filenet, Box, Alfresco, etc.
We will be happy to investigate your question.
Compliant, fast, automated and scalable
file format conversion for the regulated enterprise.
See what our beloved customers have to say about us:
And what really sets it apart from what we were doing before, DocShifter tells us what went wrong, so we can act upon the documents that did not convert".
This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently. "
The product is reliable, extremely fast and produces output that is compliant with multiple Health Authorities."