On-site and Remote Inspection Management
Regulatory inspections can be some of the most intense and stressful activities on a highly regulated company’s path to commercial success. Learn what to expect from an on-site or remote audit, how to prepare to eliminate errors, and avoid infractions. You will need to provide complete and accurate responses to the inspector’s questions and requests while maintaining effective internal communication, tracking requests, delivering documentation, and logging internal notes — all in real-time.
In this whitepaper, we identify the keys to a successful audit and recommend inspection management tools to keep your company compliant. Inspection management tools can help with:
- Efficient Document Delivery
- Internal Collaboration
- Monitoring Inspection Activity
- Advanced Data Management
- Implementing Pre-Inspection Plans
- Boosting Efficiency Fulfilling Requests
- Improve Response Time
With a well-prepared inspection management system, your company will be ready to navigate inspections with ease.
Download the “How to Ace Your Inspections” whitepaper today!
Adaptive Compliance Engine® (ACE®)
Trusted Highly-Configurable Enterprise Quality Management System
ACE® allows companies like yours to adapt and grow to meet your evolving quality management needs, without coding. ACE® is a highly configurable, workflow-based software that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With all future updates being included at no additional charge, you will be able to utilize new functions immediately. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while staying 21 CFR Part 11 compliant.
ACE Inspection® allows companies to streamline regulatory inspections by tracking all requests and logging notes in a single platform. Real-time updates and in-system notifications ensure that your team is responding to requests efficiently. With ACE Inspection® you’ll instantly have all the information you need to please your inspector at every turn.
ACE Inspection® software as a service is a cloud-based technology and can be accessed anywhere with WiFi or data on all your devices. Hosted at SOC I, SOC II and ISO 27001 certified global data centers, each release of ACE Inspection® software as a service is IQ and OQ qualified at no additional charge to reduce your validation efforts.
AuditUtopia® captures, tracks, communicates, and sorts audit activities as a real-time Inspection Audit Management System used to host inspections and audits that is trusted by life science companies worldwide. With AuditUtopia®, you can streamline your inspection process, improve response time for requests and lead end of the day meetings. Many organizations choose AuditUtopia® as the center of their inspection team to seamlessly streamline group efforts to improve response time for inspection requests.
PSC Software Solutions
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
Share, Engage, Stay Current
Cybersecurity | Keeping your data safe with eQMS
Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US government is closing ranks with energy firms to guard against attacks. How does this affect pharmaceutical and medical device...
The Pitfalls of Data Migration
Did you know that the FDA regulates data integrity? Pharmaceutical and Medical Device industries must operate in accordance with current Good Manufacturing Practices (cGMP) for regulatory industries, such as the FDA and MHRA, to deem a product as safe for consumers....
Get Your Cleanroom Ready for Business
When you think of a pharmaceutical or medical device company, cleanliness comes to mind when production comes to mind. Cleanrooms are a necessity when it comes to a company's production area. What is a cleanroom exactly? A cleanroom is a controlled environment used in...