Errors in manufacturing pharmaceuticals can cost lives. To guard against such errors and ensure a transparent paper trail, pharmaceutical regulatory agencies have some of the most rigorous and strict documentation requirements of any industry in the world.
Whether moving from paper records or from legacy document management software, PDF technology allows companies to manipulate and control their documentation processes more powerfully than ever.
Import legacy paperwork to modern databases
Pharmaceutical manufacturers are required to hold documentation for every stage of production, from the receipt of the raw materials, through the manufacturing procedures, to storage and transport. Testing is required at each stage and results must be held on file for years in case of a complaint or recall.
Due to the long timelines involved with retaining documents, many pharmaceutical companies even now are working with a mix of old paper records as well as electronic documents, or need to add paper documentation to their document management system on a daily basis.
Using an OCR reader tool, which comes packaged into many PDF SDKs, makes digitally recording old and new paper documents easy. Digital documentation makes searching record databases much easier. With OCR reader tools, any paper record can instantly be pulled up in a simple text search.
Comply with regulatory requirements
The FDA and eCTD requirements for pharmaceutical documents can be found here, and cover many aspects of document minutiae such as images, formatting and optimization for fast viewing.
Foxit PDF solutions come with the tools needed to submit fully compliant documents, without the need for additional software. By building in-house applications to manage PDFs, compliance checks can be automated to quickly flag non-compliant documents.
While any document management system solves the issue of backing up and preventing physical damage to the records, PDF technology allows companies to automatically save documents in PDF-A format. The records are readily available and organized to show to regulatory auditors upon request in the preferred format for long term storage.
Streamline processes with many stakeholders
With such extensive record keeping, pharmaceutical documents can have dozens of different stakeholders. A huge cause of lost productivity is time lost in transit between stakeholders; one manager being away for the week can cause a backlog of documentation.
Moving from paper records and physical file storage to a fully digital documentation system offers hundreds of ways to streamline these complex processes. While document management systems are a great solution to begin with, many companies find they need more power and flexibility than off-the-shelf systems provide.
With a PDF SDK, developers can create sophisticated internal applications where the mundane steps are automated. Steps can be built into workflows to automatically to check documents for regulatory compliance.
Knowing where and to who each document needs to be sent, in what order, with automatic filing and back ups, cuts the time lost between each stakeholder exponentially. Signatures and certifications are entered directly on the electronic document. This input can be done from any device – a phone, tablet, or workstation, also cutting waiting times between steps.
Keep sensitive information secure
Security is another major concern for the pharmaceutical industry. Manufacturing often uses trade secret or proprietary information which need to be kept confidential. Paper records have clear security issues, and even controls for digital documentation can fall way short of the mark.
Investing in PDF technology gives a company sophisticated methods to keep their documentation secure. From password protecting sensitive documents, to restricting access to certain users, to limiting where and when a document can be edited, downloaded or shared, among others.
With so much at stake if errors are made, ensuring the correct person signs off each process is paramount. Standard signatures are vulnerable to forgery. Digital signatures can be embedded into documents with PDF technology, and digital signature verification used to confirm them.
Foxit PDF SDK arms developers with the tools to develop enterprise-class PDF applications that fulfill all the needs of a modernizing pharmaceutical sector. Chosen by Google to be the underpinning technology for their open-source PDF engine for its versatility and power, it is the chosen PDF solution for major pharmaceutical companies such as Pfizer and Bayer.
- Built-in tools for regulatory compliance
Foxit PDF SDK comes with several built-in PDF libraries providing developers with all the tools needed to easily deliver PDF/A documents as well as all the tools necessary to produce PDF documents compliant with FDA and eCTD regulations.
- Streamlined and automated processes and workflows
Reduce document turnaround time and administrative burden by enforcing compliant document standards, introducing digital signatures and programmatically controlling the flow of documentation.
- World-class security features
Trusted by major corporations in all sectors, Foxit PDF SDK comes numerous security libraries. Secure signing with PSI, Information Rights Management (IRM) integration, encryption/decryption, password protection, access monitoring and restrictions – Foxit arms developers with the tools needed to develop ultra-secure applications.
- All-in-one solution
Foxit PDF SDK can tackle any high-level operations such as generating, editing, annotating, merging, splitting, adding content, removing content, signing, copying, pasting, allowing for streamlined collaborative generation of documents. See here for a full list of capabilities and features.
- Developer support at every step
More than just a software development kit, Foxit offers comprehensive developer support at every step. Demos and sample code are provided to help developers our staff are on hand to help integration with existing programs and workflows.