Undergoing inspections and audits is a harrowing experience. Before the FDA, EPA, or other regulatory agency inspectors visit, you need to form an Inspection Team within your company. When the inspector arrives, making a good impression sets a positive tone because the company is efficient, friendly, and meticulous. What happens when the inspector starts making requests? The most efficient and effective teams use Inspection Management Software (IMS).
What is Inspection Management Software (IMS)?
Inspection Management Software (IMS) is the alternative to using a combination of video calls, spreadsheets, logs, record systems, document generation software, and online document sharing platforms. Efficiency for fulfilling inspector’s requests is immensely improved by using a single software system to log, track, generate, and produce reports.
History of Inspection Management Software
AuditUtopia® was the first inspection management software created in 2009 by PSC Software™. AuditUtopia® is an out-of-the-box solution for effective, streamlined management for inspection events. It is the highest-rated audit software product compared to similar products on Capterra.
AuditUtopia® supports your company by providing a single platform to:
- Track and manage inspections
- Log inspection and scribe notes
- Enter and track requests
- Send notifications
- Real-time team communication
- Configurable permissions
- Generate charts and graphs
- Export reports
“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia® has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia® and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”
– Former Food and Drug Administration Commander
The Evolution of IMS – Beyond the Audit Room
After the fastest vaccine generation and rollout in US history, the need for agile management of pharmaceutical and biotechnology regulatory affairs is greater than ever. PSC Software™ is announcing the new inspection management system essential – ACE Inspection®. This new addition to the Adaptive Compliance Engine (ACE™) extends compliance inspection and audit management beyond the investigation day. ACE™ is an electronic quality management system (eQMS) for end-to-end quality and validation management. Enhance your audit readiness by integrating your day-to-day quality management processes with your inspection management software. On top of AuditUtopia®’s features, ACE Inspection® adds:
- Pre-validated installation and operational qualification (IQ/OQ)
- FDA-mandated 21 CFR Part 11 compliant electronic signatures
- Application Programming Interface (API) to integrate other software or cloud documents
- Single Sign-On (SSO) support
- Interactive charts on the dashboard
- Configurable workflows for each record type (e.g., Inspections, Requests, SME Interviews)
- Multiple report templates that pull metadata from the system (e.g., Audit, Management and Inspection Summary reports)
- Event management (due dates, scheduling, reminders)
- Audit resolution and CAPA follow-up
Choose AuditUtopia® if you want a pre-configured inspection management software to use during audits. Leveraging industry-leading features that allow teams to take scribe notes, manage requests, and create reports, AuditUtopia® streamlines inspection events. It is an unmatched economical approach to comprehensive inspection management. To extend your accuracy and preparations, choose ACE Inspection® because it encompasses processes beyond inspection day events. ACE Inspection® brings you broader capabilities with configurable workflows that allow teams to track and manage daily summary notes, near misses, and observations. PSC Software™ gives you the choice of inspection management software solutions.
PSC Biotech can provide you the highest quality CSV services on any scale. Computerized systems and software validation (CSV) provides evidence that your systems are compliant with current regulations and are suitable for their intended purpose. You want to proactively perform computer systems validations to ensure that your systems do what you intend, maintain data integrity, and meet regulatory agency requirements.
What is an Adverse Event Reporting System (AERS)? The Adverse Event Reporting System (AERS) is a computerized information database designed to support the life sciences, healthcare, biotechnology & FDA agency post-marketing safety surveillance program for all...
Accurate record management is a crucial operation for the organizations in Biotechnology, Life sciences, Pharmaceutical and Medical Equipment domains. The document content is growing enormously and manual sorting of the records makes it tedious & prone to errors....