Regulatory Compliant Information Management Solution Suite
The PharmaReady On-Demand™ Solution
With a tougher economy and tighter capital expenditures, Pharmaceutical and Life Sciences companies of all sizes are faced with the challenge of reducing their total cost of submission. PharmaReady's secure and scalable architecture offers a perfect low-cost alternative to the conventional upfront purchase of an eCTD / SPL or DMS platform license.
In addition to the traditional “on-site” implementations of PharmaReady, all PharmaReady software solutions are also available via our secure, “remotely hosted” data center. We call this, “PharmaReady On-Demand™”. To ensure maximum flexibility for our customers, we offer two creative hosted licensing models.
PharmaReady On-Demand™ Hosted Licensing Options:
1. On-Demand Term™: Our PharmaReady On-Demand Term licensing requires an annual hosting agreement. Annual Agreements can be tailored for just a few users way up to unlimited users, for the term of the hosting contract. To assist with long-term budget planning, multi-year hosting agreements are available as well. In addition, monthly, quarterly, or yearly payment plans can be structured to meet the specific budgetary needs of each client.
2. On-Demand Submissions™: Our PharmaReady On-Demand submission-based licensing agreements can be tailored for the small biotech that is planning just one or two submission all the way up to the large CRO that requires many submissions on behalf of its global customer base. On-Demand Submissions™ also offers monthly, quarterly, or yearly payment plans tailored to meet the unique budgetary requirements of each organization.
PharmaReady On-Demand™ is a secure hosted DMS, eCTD and SPL solution. With PharmaReady On-Demand there are minimal start-up costs with nothing to install on your site. No customer hardware or software is required. If overwhelming software license fees, infrastructure, and training are keeping your organization from becoming FDA compliant PharmaReady On-Demand now eliminates your roadblocks to compliance. Within a week you'll be using the features and capabilities that make PharmaReady the global leader in regulatory compliant Document Management Solutions.
- A Complete Web-based solution
- Fully Integrated DMS, SPL-PLR, and eCTD systems
- Nothing to Implement and Easy to Use
- Assured Data Security from transmission to storage
- Full FDA Part 11 and cGMP Compliance
- On-line Training and Support
- Minimal start-up Cost
- Full Part 11 and Regulatory Compliance
- Regulatory Agency level Audit Tested and Proven
- Intuitive Regulatory content assembly processes
- Web Based , multi user collaborative product
- Supports FDA, EMA, CA regional templates and life cycle management
- Submission cloning for subsequent module reuse for additional markets
- Around 80-100 SPL Labels converted every month
- The new FDA's SPL R4 capability is available
The PharmaReady solution is designed specifically for management of SOPs, work instructions, and all other documents within business areas regulated by the FDA. PharmaReady is a fully 21 CFR Part 11 compliant document management solution based on Microsoft Windows technology.
Other PharmaReady Products and Services
- Fully integrated & Regulatory Compliant PharmaReady Suite comprising
- DMS (Document Management System)
- TRMS (Training Records Management System)
- eCTD Publishing System
- SPL-PLR Publishing System
- eCTD submission consulting services for IND, NDA, ANDA, DMF, MAA, CTA
- SPL-PLR Label conversion services
- Trial Master File Document Management Services
- CDISC Data Standardization Services
Application Hosting Architecture and Security
TAKE Solutions provides a hosted solution for a client’s Document Management System / Training Records Management (DMS/TRMS) needs. The solution is secure, efficient and effective.
A PharmaReady system, hosted at the TAKE Solutions Inc. Raleigh, NC datacenter, can be integrated in the client’s Microsoft Active Directory (AD) implementation, despite the client’s geographic location.
The communication between the server and the client’s AD is enabled by first establishing an encrypted static tunnel between the client’s firewall and TAKE Solutions’ firewall. Then, the client specifies the server’s name, internal website’s http header(s), and IP address. The client creates the necessary internal DNS records, and allows the new PharmaReady server to join his/her AD.
PharmaReady On-Demand is hosted in a fully secure application hosting center in Raleigh, NC with a back-up data center in Raleigh, PA. Access to the Data Center is restricted to only critical IT support staff and the facility is controlled by a badge/card reader system. All areas are monitored by smoke detectors and ceiling sprinklers. The entire system supported by a fully operational and maintained backup diesel generator.
For more information on PharmaReady On-Demand or to schedule a free demo, please register and an account representative will contact you within 1 business day.