Description

VALIDATION MANAGEMENT SOFTWARE APPLICATION.

This validation management software application is a collaborative software (SasS) that allows the users to manage their validation documents from the cloud.

This application facilitates the identification, execution, documentation, and evaluation of the effectiveness of your validation activities.

Moreover, it brings the mechanism to document the validation records of each process and equipment.

Software Features	Basic Version – Free	Advanced Version
General Functionalities
Access Control & Password Security Encrypted – Data Privacy & Integrity	Yes	Yes
Create Users, Positions, Areas, etc.	Yes	Yes
View & Manage Documents	Yes	Yes
cGMP Audit Trail	Yes	Yes
Maximum Amount of Records & Storage Capacity	25 Records, 1 GB Storage	Unlimited Records, 50 GB Storage*
Enhanced Functionalities
Multi-User Access Control	No	Yes
Create and Manage Multi-Users Companies, Divisions or Branches	No	Yes
Electronic Signature & Approval	No	Yes
View Pending and Expired Tasks of each Employee.	No	Yes
Reports, Alarms and Notifications	No	Yes
Integration of other CIQA Quality Management Systems Modules	No	Yes
Data Backup and Restore	Simple backup functionalities.	Advanced backup & restore functionalities.*
Certification – CSV Computer System Validation, 21 CFR Part 11	No	Yes*
Technical Support	No	Yes*

* – Some fees may apply depending of some specific requirements.VALIDATION MANAGEMENT SOFTWARE APPLICATION

This secure collaborative software as a service application is fast and easy to use allowing for data sharing & connection from any place at any time.  No local servers or installation is required. Training Management System software

All quality management (GMP) information can be centralized in one secure source of database information accessible only by the designated authorized person in compliance with 21 CFR Part 11, Part 211, and Part 820.

Moreover, this application is interconnected, private and secure for GMP information

This secure software applications that can grow, replacing over 30 different software.

VALIDATION MANAGEMENT SOFTWARE APPLICATION IN COMPLIANCE WITH GAMP4 & 21 CFR PART 11.

It handles the audit trail, backup, and cGMP compatibility perfectly to comply with all FDA and International regulations.

In addition, it keeps tracking of the most important GMP information used for planning, scheduling, and follow-up pending quality management activities.

This application can automate all hard and time-consuming activities that traditionally are handled, documented, and filed manually. Training Management System software

As results, it minimize and prevent human errors, legal disputes,malpractices, and other risk or adverse situations in which pharmaceutical companies may be involved.

HIGH SECURITY AND PRIVACY OF GMP INFORMATION: AUTHENTICATION & DATA INTEGRITY.

This application allows secure routing & electronic approvals automatically of documents including follow-up of pending actions.

It helps to measure the performance and metrics of your company cGMP activities.

 TOTAL INTEGRATION OF ALL QUALITY MANAGEMENT SYSTEMS (QMS) IN JUST ONE COLLABORATIVE SOFTWARE APPLICATION.

Supporting Services during Implementation

• Training in English or Spanish.
• Validation Certifications and CSV Support: VP, URS, DS, DQ, IQ, OQ and PQ, TM, and Final Reports.

Over 34 custom application software modules can be implemented soon in different combinations to fulfill the QSR needs.  CIQA  brings  the  first consolidated software applications which can replace all available individual software such as: VALIDATION MANAGEMENT SOFTWARE APPLICATION

1. 1. Accounts Receivable & Payable Management
   2. Annual Product Review Management
   3. Audits Management
   4. Calibrations Management
   5. CAPA Investigations Management
   6. Change Control Management
   7. Cleaning and Sanitization Management
   8. Complaints Management
   9. Design Control, Specs, and P&ID’s Management
   10. EHS – Environmental Health and Safety Management
   11. Experimental Projects & Pilot Lots Management
   12. Human Resources – Management (Screening & Recruitment)
   13. Laboratory Microbiology Management
   14. Laboratory of In-Process/Finished Products Management
   15. Laboratory of Raw Materials Management
   16. Laboratory of Stability Management
   17. Laboratory Packaging Components Management
   18. Machine Setup and Configuration Management
   19. Manufacturing Scheduling & Inventory Controls Management
   20. Master Formulas & Manufacturing Instructions Management
   21. Media Fills Management
   22. MES Manufacturing Execution System Management
   23. Pest Control Management
   24. Preventive Maintenance Management
   25. Recalls, Containments, Shipping Holds, and Releases Management
   26. Regulatory Compliance Submissions Management
   27. Reprocessing / Reworks Management
   28. Retained Samples Management
   29. Returned Goods Management
   30. Risk Analysis Assessment and FMEA Management
   31. Suppliers Management – SCARS Management
   32. Standard Operating Procedures SOPs Management
   33. Training Management
   34. Validation & Qualification Management

Call us for more information about computer applications specifically designed for the FDA-regulated companies such as the biopharmaceutical and medical devices industries or click here for a brochure of the coming soon applications.

TO RECEIVE NEWS AND USEFUL VALIDATION MANAGEMENT SOFTWARE APPLICATION, SUBSCRIBE, AND FOLLOW US.

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 CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.

IF YOU HAVE ANY QUESTIONS ABOUT VALIDATION MANAGEMENT SOFTWARE APPLICATION, FEEL FREE CONTACT US (Hablamos Español)

REFERENCES:

• How to create a Validation Master Plan
• What is a Design Qualification
• How to create a User Requirement
• How to write an Installation Qualification
• How to prepare an Operational Qualification
• How to write a Performance Qualification
• How to create a Facilities Qualification
• How to create a Component Qualification
• How to make a Thermal Mapping Study
• All you need to know about cleaning validation