With over 24 years of experience, our Founder, has moved away from the Desk, to offer the sharp skills, experience and knowledge to the Pharmaceutical Industry and US Federal Government
Paperless Solution, Quality Investigations, Change Management, CAPA, Equipment Qualification, Commissioning and Process Validation Document Control Management!
All our Softwares are 21 CFR Part 11 Compliance, which includes and are not limited to Electronic Record, Electronic Signature (ER/ES), Audit Trail, Access Control Level, Group Management.
The Framework of all our Softwares include by default Administrative Tools, Backup Tool, Clean Cache, ACL (Access Control Level) Management, User Group Management, Department / Area Assignment.
Our Intended Business is to Provide Complete Turn Key Solutions
As part of our Pro-Active Service, we provide Computer System Validation Program for all our Platforms/Software. Based on GAMP5, we provide SDLC (Software Development Lifecycle) Program, for the Validation Project.
SDLC CSV Methodology includes but not limited to, Initial Risk Assessment, Impact Assessment, User Requirements (URS), Validation Project Plan, Functional Specifications (FS), Design Specifications (DS), Commissionng (SAT - Site Acceptance Test), Installation, Operational Qualification Protocol, Performance Qualification (in order to assure System Reliability under loaded conditions), Validation Project Plan Report (Closure).
Top Notch QA Compliance and Regulatory Services
Top Leading Cutting Edge Technologies for Bio/Pharma, OSD, Medical Devices and Chemical API Plants
Note: All our softwares are 21 CFR Part 11 Compliance. "Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ER/ES) and Audit Trails"
Enterprise Human Resources Management - Provides Employee Profile Electronic Mangement Record
State of the Art Electronic Platform, for Process Validation and Equipment Qualification (Document/ Project Control) DMAIC SDLC
Electronic Manual Repository for all your site Equipment, identified with site Local Equipment ID with respective Administration and Operational Manual
Change Control Management System, Scope of Work (SOW), Target Completion Date, Email Notifications, Change Tracking, Action Items, Deliverables, Functional Area Reviewers/Approvers
Advanced Document Control Mangaement System for Company Procedures (SOP's) and Policies. Version Control, and Approval Management; Superseded Documents Management for Historical Data Management
Top Class Non-Conformance (NC), Incident, Investigation Reports (IR), Laboratory Incident Reports (LIR) Mangement System. Developed following Ishikawa Methodology, from our Experts (SME's) Certified Quality Engineers (CQE)
Based on the Outcome of the Investigation Report (IR), a CAPA may be required to mantain tracking and action item continuity, and CAPA Management Platform, is integrated with Effectiveness Check for the Implementations
Our Team of Software Development Engineers GURU's, have proven the capability of High Set of Skills for the development of any Required Software for the Pharmaceutical Industry
We are Ready, are you?
All our softwares provides the capability of Web Based Mobility/ Agility Version, from a Full Desktop Version with all the Options, to a Powerfull Mobile Version that can be used from Portable Devices as Tablets, iPads, iPhones and any other Android Device.
100% Full Security Connectivity with SSL (Secure Socket Layer) (Veri-Sign McAfee Security) and Direct Connection to Business Domain Controller (Active Directory LDAP Services) (VPN and Firewalls / PROXY)
Looking forward to hear from you, lets keep in touch for new advanced technology deployment for regulatory and compliance industries!
Below are the most requested Implementation Electronic Platforms
Due to Confidential Agreement, the Identity of the Business Entity and of the Characters is Hidden from Public View
Outstanding Service, and comprehensive understanding of our needs, and capable to implement the Project from a Vision Perspective to an Actual Software turnkey solution, that complies with current needs and in QA Compliance with the Agency. A+++ 
Project Team was able to interpret an idea of the conversion from regulatory documentation, to actual paper-less solution, with the ability to comply with FDA 21 CFR Part 11, providing ER/ES, Audit Trail, Access Control Level. Will contract them again for next project
Whether you have a question about features, trials, pricing, need a demo, or anything else, our team is ready to answer all your questions.
Let's get in touch!
VC 15, Hac San José
Caguas, PR 00725
nelson.perez
@orionsglobalsolutions.com
+1 (787) 635-7770