This post is the second in our series about
Securing Intellectual Property in the Pharma sector.
Read the first post
here.

One Document. Years of Hard Work

A product dossier – sometimes also referred to as a technical file, product summary file, or a product master file – is the lifeblood of a Pharmaceutical organization. It represents years of hard work and Intellectual Property collected in a single PDF document. A product dossier contains comprehensive information about a drug: its formulation details, manufacturing and equipment details, testing data, efficacy and safety information, and so on.

This highly sensitive document needs to be shared with multiple departments within a Pharma company: R&D, Quality, Regulatory, Manufacturing, and so on. It is also sent to multiple external parties as well: regulators, auditors, vendors, and partners.

Once a copy of a product dossier goes outside your corporate firewall, it is essentially lost forever. You do not know who is doing what with it and who he/she is sending it to. Confidentiality agreements are not enough to actually secure and control this data.

Security and Collaboration: Mutually-conflicting Goals?

Security and collaboration are said to be in inverse proportion to each other. Traditional paradigms state that the more people collaborating on information, the more the risk associated with its leakage and subsequent misuse. Common security measures implemented today – such as firewalls, DLP solutions, UTM systems, IPS/IDS systems, VPN tunnels,and Disk Encryption systems – are unable to secure information once it crosses the enterprise border to go to external parties.

The reason is simple: they are not information-centric but perimeter-centric. Once the information leaves their perimeter, all security and control is lost. For example, a firewall will stop protecting assets once they move out of the enterprise boundary.

How Seclore FileSecure can Secure Your Product Dossiers

Seclore FileSecure Information Rights Management (IRM), also known as Enterprise Digital Rights Management (EDRM), embodies an information-centric security philosophy. With FileSecure IRM, information stays secure at all times and locationseven outside your corporate firewall.

Military-grade security and fine-tuned usage permissions (editing, printing, copying content, taking screen captures) are centered on the file itself. This means that the security goes where the file goes.

‘Recall’ Product Dossiers Anytime you Want

Seclore FileSecure also lets you impose time-based file-expiry features on your product dossiers. For example, one Indian Pharma major regularly sends ‘FileSecured’ product dossiers to an auditor (based in Europe) with a predefined time limit. After the period has elapsed, the dossiers automatically lock themselves and cannot be opened.

This means that organizations can now possess the incredible ability to control the time for which people can access their data. With this feature, you get complete peace of mind, knowing that:

  • The recipients cannot misuse your information. Even within the accessible period, their usage of the file would be restricted: they would not be allowed to print it, or copy content out of it, or take screen captures of it.
  • The files would be inaccessible to anyone except authorized employees of the third-party firm.
  • The information would remain secure and safe even if the third party’s network and systems are breached or compromised.
  • Finally, the information would automatically expire once it has served its purpose.

In today’s world of cut-throat competition, complex regulatory environments, generic competition, and rising costs, you cannot afford a single slipup in protecting your data. Pharmaceutical companies such as AstraZeneca, Cipla, Wockhardt, Connexios, Lupin, IPCA, Torrent, and others rely on Seclore’s technology to keep their confidential information safe and secure. Contact us today or call us at +1415 830 6240 to know more.

This article is the second in our series about how Seclore FileSecure can help Pharma companies secure their IP – wherever it goes. Click here to read the first article. Stay tuned for further posts about specific usage scenarios where FileSecure IRM can be used to secure your corporate value..