Over the last decade, the pharmaceutical industry has seen overall growth, unexpected breakthroughs, sudden mergers, and just as sudden contractions. That’s before we even mention the disruptions caused by the COVID pandemic. When the market is that turbulent, businesses understandably look for reliability wherever they can find it.
They’re looking for that reliability in many areas—their customer base, product lines, manufacturing processes, and R&D. One area many should also look at is their administrative processes, specifically physical security. Security is often treated as a cost center when pharmaceutical companies should look at it as an opportunity to create operational efficiencies and even a competitive advantage by using newer, more effective smart security management technologies.
This guide explores pharmaceutical companies' physical security challenges and lays out a clear process they can follow to evaluate and deploy the most effective physical security strategy possible. It also includes use cases for how pharmaceutical companies can benefit from those new technology platforms.
What are the top physical security challenges for pharmaceutical companies?
Pharmaceutical companies face many security threats and must deploy various measures to address them. They also must navigate a complex regulatory landscape, which can make their safety and security measures even harder to maintain.
A range of security threats and safety needs
Your physical security systems play a crucial role in safeguarding your company’s production lines and offices and your intellectual property, patents, and reputation. Each faces its own unique set of constantly-evolving threats. So it's essential to establish tight control over your facility’s perimeter, keys to access resources within your facility, and often important physical assets themselves. Pharmaceutical companies must adopt a proactive, data-driven approach to their physical security.
Strict compliance and auditing standards
Meeting your compliance obligations involves navigating a complex regulatory landscape. Security breaches and even small human errors can have outsized consequences. For example, if your organization unintentionally grants the wrong person access to sensitive locations or IP. That means your security workflows should be designed to ensure absolute reliability in granting appropriate access to your facility and sensitive assets.
How can you design a reliable physical security program for a pharmaceutical company?
Comprehensive security doesn’t have to be complex security. In fact, the more streamlined, the better for most pharmaceutical businesses. Too much complexity introduces too many potential vulnerabilities. We recommend following a straightforward but comprehensive 1, 2, 3 plan to create a reliable, streamlined security program.
What are the use cases for smart technology management systems in pharma?
Securing high-value assets
Pharmaceutical facilities house both valuable and regulated materials. Frozen concentrates, precursors, controlled substances. Their theft or loss is costly, especially when compounded by hefty regulatory fines.
Using an electronic key control system to manage access to your warehouse, storage rooms, or individual freezers automatically restricts access to individual keys by staff member, job type, or whatever conditions you need to set. Electronically-managed systems also help you more easily comply with comprehensive GMP physical security requirements.
You can also use a key management system to require double authentication for specific key sign-outs. For example, a Quality Lead or supervisor must enter their PIN or access card alongside a staff member signing out a freezer key. The system can also enable sign-out time limits, so supervisors receive an email alert if keys are not returned on schedule.
Enforcing QC quarantines
Conducting thorough, verifiable quality control audits can be a challenge, especially in open facilities like warehouses. When materials are compromised or defective devices are pulled, you must maintain strict quarantines while audits are conducted. Without electronic key management, it can be hard to prove for regulators who had access to quarantined materials definitively.
Electronic key systems automatically compile transaction logs into reports that you can pull as needed to verify quarantines or other access controls. When you conduct particularly sensitive audits, supervisors or Quality Leads can modify access on holding cages or quarantine rooms on the fly to limit access to specific personnel or to require double authentication. You can also temporarily set certain keys to have short sign-out times to help ensure that they’re only used for essential duties in quarantined locations.
Automating routine QC task management
You need to ensure that time-sensitive tasks are completed on schedule. This might include ambient temperature checks in freezer rooms or inventory checks in warehouses in pharma facilities. These tasks can be hard for senior QC to delegate and often remain ‘high-touch’ even when delegated.
This issue could be addressed by setting time limits on key sign-outs. The key system itself can automate some task management by notifying supervisors or Quality Leads if keys aren’t returned on schedule. Enabling double authentication for key sign-outs also helps, and letting supervisors check the system’s web app from their phone for live updates on key usage.
You must audit and report who can access freezers, safety cabinets, and hazardous materials. Efficiently tracking this access is challenging, especially if you’re in a multi-use facility where personnel from other departments use or pass through your space.
The transaction reports automatically compiled by electronic key systems are highly customizable. You can adapt them to your GMP audit needs or internal policy controls.
Any time limit alerts you’ve enabled on keys for sensitive assets can also be reported. These alerts can be added to your access reports to easily identify trends in employee accountability or access trends for particular assets. Are freezer checks in one portion of your warehouse consistently late? Are certain employees routinely running up against time limits? Additionally, you could utilize a smart locker system to control sensitive chemicals.
The ProblemManually checking certifications and enforcing safety policies is time-consuming. But any accident after an employee forgets to renew a safety certification can incur hefty occupational safety violations on top of workplace injury claims.
Real Time Networks’ key and fleet management systems can also control access based on certification status. For example, if an employee in your warehouse lets their forklift or scissor lift certifications expire, the system can lock them out of the vehicle key pool until they update their certs.
These key lockouts are customizable. For example, you can enable override access for emergency response teams so they can always access the vehicles or spaces they need.
Pharmaceutical businesses face a variety of challenges in securing their supply chain. There’s no magic bullet solution, but electronic key management systems can solve many of those challenges.
Contact Real Time Networks today for expert advice on designing your pharmaceutical company’s new physical security program.
About the Author
Vice President of Marketing
Jay oversees marketing and strategic partnerships at Real Time Networks and has over three decades of experience in leadership roles in the financial services and technology industries.