Get The FDA Bulletin On ExcelSafe
follow
http://www.ofnisystems.com/fda-releases-laboratory-investigation-bulletin-discussing-their-use-of-excelsafe/
follow
http://www.ofnisystems.com/
Products
follow
http://www.ofnisystems.com/products/
Services
follow
http://www.ofnisystems.com/services/
Information
follow
http://www.ofnisystems.com/information/
About
follow
http://www.ofnisystems.com/about-ofni/
Contact
follow
http://www.ofnisystems.com/contact/
ProductsOfni Systems provides your FDA-regulated business with software and products to assist with 21 CFR 11, Annex 11, HIPAA, and other regulatory requirements for electronic data and signatures.
follow
http://www.ofnisystems.com/products/excelsafe/
ExcelSafe Part 11 Compliance For MS Excel® Spreadsheets
follow
http://www.ofnisystems.com/products/excelsafe/
Simple To Use Get spreadsheet control in a matter of hours
follow
http://www.ofnisystems.com/products/excelsafe/summary/
Full Part 11 ComplianceAudit trails, electronic signatures and user security
follow
http://www.ofnisystems.com/products/excelsafe/details/
Spreadsheet ValidationWe are FDA experts on spreadsheet validation
follow
http://www.ofnisystems.com/services/validation/spreadsheet-validation/
Free TrialGet a copy of Excelsafe to test today
follow
http://www.ofnisystems.com/products/excelsafe/how-to-buy/
FastValA Complete Validation Management Solution
follow
http://www.ofnisystems.com/products/fastval/
Create Documents Fastval creates all your validation documents
follow
http://www.ofnisystems.com/products/fastval/details/document-generator/
Electronic ExecutionExecute validation protocols electronically
follow
http://www.ofnisystems.com/products/fastval/details/protocol-execution/
Deviation Tracking Deviation generation, tracking and management
follow
http://www.ofnisystems.com/products/fastval/details/deviation-tracking/
Project Management Tools and reports to help manage people & projects
follow
http://www.ofnisystems.com/products/fastval/details/validation-project-management/
Ofni ClinicaleCRF Data Collection Database For Clinical Trials
follow
http://www.ofnisystems.com/products/ofni-clinical/
Case Report FormsConverts your paper CRF"s into eCRF"s
follow
http://www.ofnisystems.com/products/ofni-clinical/electronic-case-report-forms-for-clinical-trials/
Edit ChecksEnsure data integrity with validation rules
follow
http://www.ofnisystems.com/products/ofni-clinical/edit-checks/
MedWatch ReportingAutomatically generates MedWatch FDA Form 3500A
follow
http://www.ofnisystems.com/automatic-generation-of-fda-form-3500a/
Rapid ImplementationReady to use in days, not weeks or months
follow
http://www.ofnisystems.com/products/ofni-clinical/summary/
Part 11 ToolkitMakes Any MS Access® Database Part 11 Compliant
follow
http://www.ofnisystems.com/products/part-11-toolkit/
Audit TrailsTrack all changes made in a database
follow
http://www.ofnisystems.com/products/part-11-toolkit/audit-trails/
Electronic SignaturesSecure data with electronic signatures
follow
http://www.ofnisystems.com/products/part-11-toolkit/electronic-signatures/
Database ValidationLet us validate your database for you
follow
http://www.ofnisystems.com/services/validation/computer-systems/access-databases/
Free Trial Try the Part 11 Toolkit in your own database
follow
http://www.ofnisystems.com/products/part-11-toolkit/free-trial-offer/
Part 11 AdvisorPart 11 Auditing, Remediation and Training Tool
follow
http://www.ofnisystems.com/products/part-11-advisor/
Starting Gap AnalysisFacilitates the process of starting gap analysis
follow
http://www.ofnisystems.com/products/part-11-advisor/starting-gap-analysis/
AssessmentsCollect and review data to identify Part 11 gaps
follow
http://www.ofnisystems.com/products/part-11-advisor/assessments/
Long-Term TrackingTrack the completion of your corrective action plan
follow
http://www.ofnisystems.com/products/part-11-advisor/long-term-tracking/
On-site ImplementationHands on training on 21 CFR Part 11
follow
http://www.ofnisystems.com/products/part-11-advisor/implementing/
ServicesOfni Systems provides your business with the highest quality consulting services to meet all of your compliance and quality needs.
follow
http://www.ofnisystems.com/services/
Validation Services
follow
http://www.ofnisystems.com/services/validation/
Software Validation
follow
http://www.ofnisystems.com/services/validation/computer-systems/
Method Validation
follow
http://www.ofnisystems.com/services/method-validation/
Process Validation
follow
http://www.ofnisystems.com/services/validation/process-and-equipment/
Equipment Validation
follow
http://www.ofnisystems.com/services/validation/process-and-equipment/
21 CFR Part 11
follow
http://www.ofnisystems.com/21-cfr-part-11/
Part 11 Training
follow
http://www.ofnisystems.com/services/compliance-training/
Part 11 Auditing
follow
http://www.ofnisystems.com/services/gxp-compliance-auditing/
Compliance Testing
follow
http://www.ofnisystems.com/services/software-testing/
Software Assesments
follow
http://www.ofnisystems.com/services/part-11-assessments/
Clinical Trials
follow
http://www.ofnisystems.com/services/ofni-clinical-group/
Custom Databases
follow
http://www.ofnisystems.com/products/ofni-clinical/
Database Testing
follow
http://www.ofnisystems.com/services/validation/computer-systems/
Statistical Analysis
follow
http://www.ofnisystems.com/services/ofni-clinical-group/
Statistical Reporting
follow
http://www.ofnisystems.com/services/ofni-clinical-group/
Other Services
follow
http://www.ofnisystems.com/services/validation/
Data Migration
follow
http://www.ofnisystems.com/services/data-migration/
SOP Writing
follow
http://www.ofnisystems.com/services/sop-writing/
Process Automation
follow
http://www.ofnisystems.com/services/custom-gxp-programs/
Mock Audits
follow
http://www.ofnisystems.com/services/gxp-compliance-auditing/
InformationOfni Systems is committed to assisting organizations with electronic records compliance, such as 21 CFR Part 11 and Annex 11. Let Ofni Systems make knowledge management simple for you.
follow
http://www.ofnisystems.com/products/excelsafe/
21 CFR Part 11A complete set of resources for 21 CFR Part 11
follow
http://www.ofnisystems.com/21-cfr-part-11/
21 CFR 11.10(a)Validation of computer systems
follow
http://www.ofnisystems.com/information/resources/introduction-to-21-cfr-11/21-cfr-11-10a-validation-of-systems/
21 CFR 11.10(b)Accurate Generation of Records
follow
http://www.ofnisystems.com/21-cfr-11-10b-accurate-generation-of-records/
21 CFR 11.10(c)Protection of Records
follow
http://www.ofnisystems.com/21-cfr-11-10c-protection-of-records/
21 CFR 11.10(d)Limited System Access
follow
http://www.ofnisystems.com/21-cfr-11-10d-limited-system-access/
21 CFR 11.10(e)Audit Trails
follow
http://www.ofnisystems.com/21-cfr-11-10e-audit-trails/
21 CFR 11.10(f)Operational System Checks
follow
http://www.ofnisystems.com/21-cfr-11-10f-operational-system-checks/
21 CFR 11.10(g)Authority Checks
follow
http://www.ofnisystems.com/information/resources/introduction-to-21-cfr-11/21-cfr-11-10g-authority-checks/
21 CFR 11.10(h)Input Checks
follow
http://www.ofnisystems.com/21-cfr-11-10h-input-checks/
21 CFR 11.10(i)Education, Training and Experience
follow
http://www.ofnisystems.com/21-cfr-11-10i-education-training-and-experience/
21 CFR 11.10(j)Policies for Electronic Signatures
follow
http://www.ofnisystems.com/21-cfr-11-10j-policies-for-using-electronic-signatures/
21 CFR 11.10(k)Document Control
follow
http://www.ofnisystems.com/21-cfr-11-10k-document-control/
Part 11 FAQValidation of computer systems
follow
http://www.ofnisystems.com/information/resources/introduction-to-21-cfr-11/
Validation ResourcesOn selected validation documents
follow
http://www.ofnisystems.com/products/excelsafe/
Validation PlanningDefine the scope and goals of a validation project.
follow
http://www.ofnisystems.com/services/validation/validation-plans/
Requirement GatheringOperations and activities that a system must be able to perform.
follow
http://www.ofnisystems.com/services/validation/functional-requirements/
Design SpecificationDesign Specifications describe how a system performs the requirements
follow
http://www.ofnisystems.com/services/validation/design-specification/
Installation QualificationVerifies the proper installation and configuration of a System.
follow
http://www.ofnisystems.com/services/validation/installation-qualification/
Summary ReportProvides an overview of the entire validation project.
follow
http://www.ofnisystems.com/services/validation/summary-report/
Other ResourcesMore information on FDA compliance
follow
http://www.ofnisystems.com/products/part-11-advisor/
FDA Warning LettersSample FDA 483 and Warning Letters
follow
http://www.ofnisystems.com/fda-warning-letters/
Part 11 PublicationsUseful 21 CFR 11 resources.
follow
http://www.ofnisystems.com/information/resources/
Clinical Data ManagementBest practices in handling data from clinical trials.
follow
http://www.ofnisystems.com/information/resources/introduction-to-clinical-data-management/
Ofni Compliance BlogResources and information straight from the Ofni team.
follow
http://www.ofnisystems.com/blog/
About Ofni SystemsOfni Systems is dedicated to helping companies address the requirements of 21 CFR Part 11, Electronic Records and Electronic Signatures.
follow
http://www.ofnisystems.com/about-ofni/
Clients
follow
http://www.ofnisystems.com/clients/
Alliances
follow
http://www.ofnisystems.com/alliances/
Employment
follow
http://www.ofnisystems.com/employment-opportunities/
Customer Support
follow
http://www.ofnisystems.com/information/support/
follow
http://www.ofnisystems.com/products/fastval/
Learn More About FastVal
follow
http://www.ofnisystems.com/products/fastval/
follow
http://www.ofnisystems.com/products/excelsafe/
Learn More About ExcelSafe
follow
http://www.ofnisystems.com/products/excelsafe/
follow
http://www.ofnisystems.com/products/ofni-clinical/
Learn More About Ofni Clinical
follow
http://www.ofnisystems.com/products/ofni-clinical/
Computer Validation
follow
http://www.ofnisystems.com/services/validation/
Part 11 Assessments
follow
http://www.ofnisystems.com/services/part-11-assessments/
Process and Equipment Validation
follow
http://www.ofnisystems.com/services/validation/process-and-equipment/
Ofni Clinical Group
follow
http://www.ofnisystems.com/services/ofni-clinical-group/
Custom Programs
follow
http://www.ofnisystems.com/services/custom-gxp-programs/
Compliance Training
follow
http://www.ofnisystems.com/services/compliance-training/
Products
follow
http://www.ofnisystems.com/products/
Services
follow
http://www.ofnisystems.com/services/
Information
follow
http://www.ofnisystems.com/information/
About
follow
http://www.ofnisystems.com/about-ofni/
Contact
follow
http://www.ofnisystems.com/contact/
Privacy
follow
http://www.ofnisystems.com/privacy-statement/
Terms Of Use
follow
http://www.ofnisystems.com/terms-of-use/
| (919) 844-2494
follow
tel:+19198442494
follow
//plus.google.com/u/0/100052180972927863546?prsrc=3