OpsTrakker GMP Solutions
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Standardize Activity Completion and Eliminate GMP Paper Forms, Checklists, and Workflows
Countless plant operations are carried out using paper checklists and forms. These documents are oftentimes incomplete or executed improperly. Moreover, paper requires a physical presence for wet signatures and prohibits cross-team cooperation and remote work.
eForms are digitized forms which enable standardized activity completion and electronic data capture via tablet or web browser. OpsTrakker eForm solution has been created using a mobile-first approach to ensure they can be accessed and reviewed from anywhere.
What Paper do OpsTrakker Digital Forms replace?
- SOP Checklists
- Quality Control Forms
- Training Records
- Deviation Forms
- CAPA Forms
- Cleaning Verification Forms
- Visitor Sign-In Sheets
- EHS Assessments
- And many more...
OpsTrakker eForms Solution
Electronic Form Management and Visual Work Instructions
With electronic forms and checklists, OpsTrakker drives productivity and standardization so that all activities are complete and correct. Above all, digital forms and checklists eliminate paper based documents to help you achieve your digitalization and sustainability goals. OpsTrakker eForms have been created with GMP in mind. OpsTrakker is audit ready and compliant with federal regulations for electronic signatures (FDA 21 CFR Part 11 and EU Annex 11).
With more than 25 years of industry experience, we have assisted some of the biggest players in the industry advance their digitalization ambitions. Digitized forms and checklists not only make life easier for operational staff, but are also easier to audit and extract data. All information is stored in a central location and can be accessed quickly and easily by all authorized personnel without spending hours sifting through paper forms.
Solution features
- Real-time visibility for all authorized personnel
- Leveraging parameterization for form flexibility and reuse
- Highly configurable workflows, requiring little to no customization
- Enforced completion and status checks
- Integration with external systems and IIoT for status management
- Mobile first approach, built with the Operator in mind
- Available to view, edit and authorize according to security groups
- FDA 21 CFR Part 11 and EU Annex 11 compliant
- Visual Work Instructions to Achieve Right First Time Execution
OpsTrakker eForms solution supports the range of operator activities for form entry. The workflow engine standardizes shop-floor activities and guides the user to complete activities right the first time. Our eForms are flexible and configurable to replace any paper-based GMP forms within your facilities.
Problems solved
- Eliminate paper-based forms and checklists from your production floor
- GxP errors and observations
- Physical presence required for wet signatures
- Lost and damaged paper
- No way to track and trend collected information
- Incomplete or inaccurate data input
- Lost or misplaced paper forms
- Illegible completion of paper forms
- High cost and inefficiencies associated with storing paper-based forms
- Bulky to store and not easily retrievable
The environmental impact of paper records is substantial. Each document must be controlled throughout its life cycle. By the end, the document must be archived and destroyed. Such a process can produce tens if not hundreds of thousands of GMP paper records across an organization. Taking such a view makes the environmental impact of such a system apparent. OpsTrakker eliminates the need for paper-based GMP records as all workflows and records are completed digitally. Thus, helping your organization reduce your environmental impact and support your sustainability goals.
Benefits delivered
- Non-Equipment specific activity form and checklist configuration
- Right-First-Time Workflow Execution
- Improved operator efficiency
- Reduced Environmental Impact
- Extremely high accessibility for analytics, review and tracking
- GMP paper record and document elimination for digital alternatives
- Audit-Ready Environment
- Secured electronic record and document storage in a central location
- Compliant Electronic Signature Authorization (US FDA 21 CFR Part 11 and EU Annex 11)
- Enhanced compliance and reduced GxP errors and observations
Frequently Asked Questions
What are electronic forms (eForms) for pharmaceutical manufacturing?
Electronic forms, or eForms, are digital versions of paper forms, checklists, and operational records used to capture information during manufacturing activities. OpsTrakker eForms enables pharmaceutical and life sciences manufacturers to replace paper-based GxP forms with controlled digital workflows and structured electronic records.
What is GMP electronic forms software?
GMP electronic forms software digitizes forms and records used within Good Manufacturing Practice environments. OpsTrakker eForms helps manufacturers standardize data collection, guide users through required activities, maintain traceability, and create controlled electronic records for regulated manufacturing processes.
How can pharmaceutical manufacturers replace paper forms with electronic forms?
Pharmaceutical manufacturers can replace paper forms with digital workflows that guide operators through required fields, steps, approvals, and signatures. OpsTrakker eForms converts paper-based manufacturing processes into configurable electronic workflows that capture information directly at the point of execution.
What types of GMP forms and checklists can be digitized?
Electronic forms can be used for many GxP manufacturing processes, including inspections, checklists, equipment checks, cleaning records, line clearance, safety checks, quality records, production forms, shift activities, and other operational documentation. OpsTrakker eForms can be configured around the specific workflow and data requirements of each process.
How do electronic forms support 21 CFR Part 11 requirements?
Electronic forms used in regulated environments can support 21 CFR Part 11 requirements through capabilities such as electronic records, electronic signatures, audit trails, user authentication, access controls, and record traceability. OpsTrakker is designed for regulated pharmaceutical and life sciences manufacturing environments.
How do electronic forms improve data integrity in GxP manufacturing?
Electronic forms can improve data integrity by enforcing required fields, controlling data entry, recording timestamps and user activity, maintaining audit trails, and reducing handwritten entries and manual transcription. OpsTrakker eForms captures structured data directly during workflow execution to create more complete and traceable manufacturing records.
What is a digital manufacturing checklist?
A digital manufacturing checklist is an electronic workflow that guides operators through required tasks, inspections, verifications, or process steps. OpsTrakker eForms can digitize paper checklists and incorporate required fields, conditional steps, approvals, signatures, and other workflow controls.
Can electronic forms use conditional logic and dynamic workflows?
Yes. Digital forms can use conditional logic to change the workflow based on operator responses, process conditions, or entered data. OpsTrakker eForms enables configurable workflows that can present relevant steps, fields, instructions, or actions based on the information captured during execution.
Can electronic forms reduce manufacturing documentation errors?
Yes. Electronic forms can reduce documentation errors by requiring necessary information, standardizing data entry, guiding users through defined workflows, and identifying incomplete or incorrect information before a record is completed. This reduces many of the errors associated with handwritten and manually transcribed manufacturing records.
What is the difference between an electronic form and a paper form?
A paper form primarily records information as a static document. An electronic form can actively guide execution, validate entries, require specific information, capture electronic signatures, apply conditional logic, maintain an audit trail, and make captured data immediately available for review and analysis.
Can electronic forms integrate with MES, ERP, LIMS, QMS, and other manufacturing systems?
Yes. Electronic forms can be integrated with manufacturing and enterprise systems such as MES, ERP, LIMS, QMS, CMMS, and other data sources. OpsTrakker is designed to digitize operational workflows while connecting them with the broader manufacturing technology environment.
How do electronic forms support paperless manufacturing?
Electronic forms eliminate paper at the point where manufacturing information is created. Instead of completing a paper form and later reviewing, filing, or manually entering its information into another system, OpsTrakker eForms captures structured digital data during execution, helping manufacturers move toward paperless operations.
Can electronic forms provide real-time manufacturing data?
Yes. Because information is captured digitally at the point of execution, electronic forms can make manufacturing data available much faster than paper-based processes. OpsTrakker eForms enables authorized users to access completed records and operational information without waiting for paper documentation to be collected and processed.
What is OpsTrakker eForms?
OpsTrakker eForms is electronic forms and digital workflow software designed for pharmaceutical and life sciences manufacturing. It replaces paper forms, checklists, and manual records with configurable digital workflows that provide structured data capture, electronic records, traceability, workflow controls, and improved operational visibility.