Over the last decade, the pharmaceutical industry has seen overall growth, unexpected breakthroughs, sudden mergers, and just as sudden contractions. In such a turbulent market businesses are looking to create reliability wherever they can.
Advanced key management systems can help solve a variety of problems that pharmaceutical firms face both securing their supply chain and meeting Good Manufacturing Practice (GMP) standards.
1) 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.
2) 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 pulled, you need to maintain strict quarantines while audits are conducted. Without electronic key management it can be hard to definitively prove for regulators who had access to quarantined materials.
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.
3) Automating Routine QC Task Management
You need to ensure that time-sensitive tasks are completed on schedule. In pharma facilities this might include ambient temperature checks in freezer rooms or inventory checks in warehouses.
These tasks can be hard for senior QC to delegate, and often remain ‘high-touch’ even when they are delegated.
This is another issue that 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.
4) Automating Reporting
You need to audit and report who has access to freezers, safety cabinets, and hazardous materials. Efficiently tracking this access is challenging, especially if you’re in 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 as needed to your particular GMP audit needs or internal policy controls.
Any time limit alerts you’ve enabled on keys for sensitive assets can be reported as well. 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 an Asset Locker or a Smart Locker System to control sensitive chemicals.
5) Enforcing Workplace Policies
Manually checking certifications and enforcing safety policies is time-consuming. But any accident after an employee forgot 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 to.
Pharmaceutical businesses face a variety of challenges securing their supply chain. There’s no magic bullet solution, but electronic key management systems can solve many of those challenges.
About the Author
Shannon Arnold is the VP of Marketing and Strategic Partnerships at Real Time Networks.