Are you still wasting time digging through paper binders to find your latest Standard Operating Procedure (SOP)? It’s time to eliminate manual processes and:
Improve Quality
Document Lifecycle Management
Full electronic document lifecycle management support that starts at document inception through to revision, collaboration, approval routing(s), read-and-sign training, and release.
Document Security
Seamlessly ensure the right document is found in the right place at the right time by the right team member.
Accelerate Document Approval
Streamline your document approval process with Title21’s automated document routing tools that come complete with built-in audit trails and support for 21 CFR Part 11 compliant electronic signatures.
Learning Management System (LMS)
Detailed training records make it easy for you to ensure 100% employee training on all controlled documents through read-and-sign training, automated scheduled periodic reviews, and built-in 21 CFR Part 11 compliant electronic signatures.
Streamline CAPAs
Launch Corrective and Preventative Actions (CAPAs) when and where they happen with streamlined data collection and full traceability into the investigation and solution.
Reduce Risk
CAPA and Deviation Management
Drive continuous quality improvement with streamlined, electronic tools to document, track, and manage planned and unplanned deviations including support for automated escalation workflows and full CAPA resolution.
Audit Management
Streamline and automate your complete auditing lifecycle from audit creation, assignment, execution, and reporting so you can always be inspection ready.
Complaint Management
Ensure compliance to FDA and GMP guidelines with intuitive electronic complaint intake forms that support the complete documentation, investigation and resolution of customer feedback and complaints.
Training Management
Ensure your staff is properly trained at all times with instant access to staff training progress and status, SCORM integration, laboratory competency checklists, and secured training records.
Validation Documentation
Complete validation package suitable for inspection by regulatory and accreditation agencies.
Deliver Better Products
Best-in-Class Templates
Title21’s standardized forms and workflows are flexible to your business processes to support a rapid on-site or cloud deployment.
Automate Traceability
Produce detailed, accurate documentation with complete lot-to-lot traceability for all of your units complete with streamlined tools to support recalls and risk assessments.
Maximize Capacity
Ensure on-time, high-quality equipment management throughout your operation with automated scheduling and documentation for your preventive equipment maintenance and calibration tasks.
Increase Visibility
Automate manual training tasks, simplify controlled document access, and promote consistency and document access across your organization.
Actionable Data Insights
Personalized dashboards let you easily identify trends and patterns, ensure staff training is current, and organize and prioritize automated tasks for each of your team members so they can stay focused on what they need to do.
Case Study: Document Control Savings
“The success factor for ImpactLife was maximizing the benefits on an electronic system including eliminating non-value added steps, lag time and decreasing the lifecycle duration."
Director of Regulatory Compliances
ImpactLife
13 Hours
Per week of departmental staff time reallocated to operational duties
19 Hours
Weekly reduction in time spent managing document version control
82%
Decrease in hard copy manuals by implementing electronic versions
208 Days
Saved per year in employee time managing hard copy manuals
Included Modules
Document Control & Read & Sign Training
Seamlessly and intuitively manage all your revision-controlled documents from creation through to revision, collaboration, approval routing, read-and-sign training, and release.
Learning & Competency Management
Maintain an effective employee training program and promote high quality operations with a fully electronic training curriculum designed to manage each users’ training progress, re-training requirements, and training history.
Error Management
Reduce compliance risks and improve patient safety with electronic management of all your incidents, non-conformances, planned and unplanned deviations, and occurrences.
Complaint Management
Document and accelerate your complaint investigation and resolution processes through standardized forms, automated workflows, and built-in data insights.
Change Control
Foster organizational change and continuous improvement with a streamlined, electronic change control process that automates your impact assessment, review and approval workflows, and related personnel notifications.
Audit Management
Streamline your full auditing lifecycle from audit creation, assignment, execution and reporting while also taking advantage of automated scheduling, internal and external audit forms support, and built-in risk assessment and reporting tools.
CAPA/Deviations & Non-Conformance
Streamlined, electronic tools to document, track, and manage planned and unplanned deviations including support for automated escalation workflows and full CAPA resolution.
Supplies & Equipment Management
Track critical equipment and supplies while improving traceability of products.
Accreditation Management
All the tools you need to support the ever-changing requirements for accreditation including FACT/JACIE, AABB, ISBT 128, HIPAA, 21 CFR Part 11 and more. and more.
Solution Overview
Enterprise Quality Management System
Streamline your quality processes, minimize administrative burden, and reduce operational risk with a secure, intuitive, and compliant platform for end-to-end quality management. Download your free Solutions Overview today.
Complete the form to download.
Ready to Focus More on Patients and Less on Paperwork?
Learn more on how Title21's industry leading cellular therapy software solutions can help you save more lives.