Solutions

Pharmaceutical & Medical Device Systems

adWATCH – AE gives the medical professional a fast and effective means of generating and managing Adverse Event Reporting (AERs).

adWATCH – CAPA – Corrective and Preventive Action (CAPA) helps organizations capture, distribute, retrieve, and manage corrective action requests and preventive action requests globally and in real-time.

adWATCH – PCM – Product Complaint Management (PCM) helps organizations capture, distribute, retrieve, and manage product complaints globally and in real-time.

adWATCH – SERVICE extends the atWATCH-PCM offering to include service and repair of existing products. atWATCH-SERVICE assists in managing field resources of repair technicians as well as field inventories. atWATCH-SERVICE manages customer returns for repair and upgrade purposes.

ComPac is an out of the box set of tools than can be integrated into your Domino environment to achieve 21 CFR part 11 compliance.

CTMS – FastCTMS is a web-based solution tailored for small biotechs, pharmas, medical device manufacturers, and CROs. It DOES NOT require an army of consultants and an endless timeline to implement. FastCTMS can be accessed and used by trial team members with desktops, laptops, and mobile devices. FastCTMS provides a proven, pre-configured solution that’s fast and easy to implement, helping companies reap the benefits of a CTMS—efficiently and cost-effectively.

CTMS – Protocol Manager is a full-scope, configurable, off-the-shelf Clinical Trials Management System (CTMS). atProtocol helps clinical operations manage global trials of drugs, devices, biologics, and vaccines in all phases of development. When the appropriate Standard Operating Procedures (SOPs) are implemented in your company, atProtocol can help you be compliant with the FDA’s 21 CFR part 11 regulations

HATS – Health Agency Tracking (HATS) manages queries and the corresponding responses between pharmaceutical companies and their respective Health Agencies.

Portal- Investigator is a new module that makes it even easier for sites, sponsors and CRO partners to collaborate on trials. The atPortal-Investigator provides a secure workplace where a site can log on and see the latest trial data pertaining to that site’s patients and personnel.

paraFILE is an Electronic Document Management system that can be tailored to fit your enterprise and each departmentally different EDM requirement.

Training Campus – A life sciences company’s quality managment initiatives must incorporate assurances that employees are performing functions in accordance with qualifications, corporate policies and industry regulations.

Manufacturing Systems

ECC – Engineering Change Control allows enterprises to obtain and maintain control over product, process, and equipment changes.

Security Agent

AtSignOn - Enables secure access to Lotus databases, files and URL directories with two-factor authentication.