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Hill Dermaceuticals Switches to GlobalSign for Easy-to-use, FDA Compliant Digital Signatures

Hill Dermaceuticals Switches to GlobalSign for Easy-to-use, FDA Compliant Digital Signatures

So many signature solutions are targeted for large corporations and we struggled to find a solution that was affordable, effective, and compliant. GlobalSign’s flexible solutions and dedicated, responsive support teams were a pleasant change compared to what we were used to.

Jeff Tabatabai, Director of Operations, Hill Dermaceuticals

What we like about GlobalSign is its reputation and track record as a commercial Certificate Authority (CA). We have a strong level of trust with GlobalSign.

— Mike Patterson, Manager, Information Security Operations Information Security Services, University of Waterloo

waterloo university
CUSTOMER PROFILE
INDUSTRY Pharmaceutical
USER BASE 35+ employees applying 14,000+ signatures per year
GLOBALSIGN SOLUTION Token-based Digital Signatures

At a Glance

PROBLEM

Hill Dermaceuticals sought a cost-effective digital signature solution that would simplify the signing process for employees and make it easier to comply with FDA CFR 21 Part 11 requirements.

SOLUTION

GlobalSign document signing certificates include third party timestamping and can apply unlimited publicly trusted digital signatures for one flat rate. The token-based solution makes it easy for employees to sign and includes timestamping and password management features to help meet FDA compliance.

Challenge

Hill Dermaceuticals, a pharmaceutical company that specializes in dermatology products for adults and children with difficult to treat skin diseases, adopted digital signatures in place of wet ink signatures as part of an effort to go paperless. Given the amount of signed documentation the company generated and had to maintain, relying on physical documents was not efficient. Switching to electronic workflows saved significant time, particularly when it came to searching for and accessing past documents.

While their original signature solution helped streamline processes, the pricing scheme was changing to charge per signature and there was additional room for improvement, including the need to separately source timestamping and the signatures were not automatically trusted when sent to outside parties. Hill Dermaceuticals sought an easier-to-use, more cost-effective signature solution that would also make it easier for them to comply with FDA CFR 21 Part 11, a regulation with which they needed to comply as a pharmaceutical company.

Solution Requirements

  • Comply with FDA CFR 21 Part 11 electronic signatures requirements
  • More cost-effective than previous vendor which charged per signature
  • Ability to enforce FDA’s password policy without manual intervention
  • Signing process must be simple for employees
  • Included trusted timestamping service would be a plus, so it would not have to be sourced separately
  • Publicly trusted signatures would also be a plus, so documents sent outside the organization would not show warning messages

Solution

GlobalSign’s document signing certificates stored on cryptographic USB tokens are a perfect fit for Hill Dermaceuticals’ needs. Users can sign as many documents as needed for one flat rate and the signatures are true PKI-based digital signatures, the strongest type of electronic signature available and they map to FDA CFR 21 Part 11 requirements. Storing the certificates on portable tokens makes it easy for employees to sign and the cryptographic tokens offer advanced password management, which makes it easier to enforce the FDA’s password rules.

Third party timestamps are automatically included with every signature, which helps protect against fraud, backdating, and helping to ensure data integrity. Everyone, from other employees to auditors, can trust when the signature was applied without the need to separately source a timestamping service. Additionally, there is no need to manually push out trust anchors if the signed documents are sent externally. GlobalSign is a member of both Adobe’s Approved Trust List (AATL) and Microsoft’s Root Trust List, so all digital signatures are automatically trusted.

“So many signature solutions are targeted for large corporations and we struggled to find a solution that was affordable, effective, and compliant. GlobalSign’s flexible solutions and dedicated, responsive support teams were a pleasant change compared to what we were used to. They don’t ignore the smaller companies and I really appreciate that. I recommend them to anyone who wants a straightforward solution with excellent customer service.” - Jeff Tabatabai, Director of Operations, Hill Dermaceuticals

What’s Achieved?

  • Using electronic documents instead of physical paper, Hill Dermaceuticals’ processes are much more efficient and employees can access documents much more quickly – 10x faster compared to physical documents
  • Built-in timestamping and the token’s native password management capabilities make it easier for Hill Dermaceuticals to meet FDA compliance
  • Compared to previous solution, it’s easier and faster for employees to sign If signed documents need to be sent outside the organization, the signatures are automatically trusted; there is no need for Hill Dermaceuticals to manually push out trust anchors

Ready to discuss your document signing needs?

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