PRO_IRB

PRO_IRB™ is a Microsoft Access-based Institutional Review Board Software Application providing productivity and compliance assurance tools for managing the Institutional Review Board process. Agenda preparation, records SAE, manage continuing review. Complies and exceeds 21CFRpart11 requirements where applicable.

SymPro V3/V4

The Symfo is a portable, one-hand operable, electronic patient diary capable of recording patient data in REAL TIME. This secure data transmission will provide a better follow-up of the patient without making a contact between the patient and the investigator necessary. The system has been developed and is produced according to the strict ISO 9001 procedures. The Symfo is a portable, one-hand operable, electronic patient diary capable of recording patient data in REAL TIME. This secure data transmission will provide a better follow-up of the patient without making a contact between the patient and the investigator necessary. The system has been developed and is produced according to the strict ISO 9001 procedures. The system is FDA Part 11 Compliant.

Silverstream V2.5

Janssen have successfully removed the paperwork from the change control process The system is compliant with FDA regulation 21 part 11. Because the system is intranet based, changes or amendments can be made at server level and deployed immediately.

Applied Stats SPC software suite

Our Applied Stats SPC software suite meets all the requirements of 21 CFR Part 11, and provides SPC data collection, analysis and reporting solutions for pharmaceutical manufacturing processes. ASI DataMyte Quantum software, coupled with our data collection devices, provides analysis and reporting capability for process control metrics.

Chromeleon

New Electronic Signature and Signoff feature provides electronic signatures in conformance to FDA's 21 CFR Part 11 rules. Unique signoff levels allow users to submit, review, and approve electronic records from CHROMELEON efficiently and completely.

MCS Now

eMedia-IT's web-based infrastructure allows your company to meet key FDA compliancy requirements while managing the secure sharing of files within your organization as well as with other organizations, features such as: User authentication upon login, Dynamic file viewing, Group and user management, File and folder access permissions, Version control and file history, Read only audit trail.

Entrust/PKI

Digital Certificate technology can be used to ensure access control, authentication and non-repudiation of digital transmissions. Entrust provides a digital certificate-based solution for digital signature and encryption, that will meet the requirements of the FDA for organizations that want to use electronic records and signatures.

eOriginal

The eOriginal™ system meets or exceeds all of the FDA requirements for electronic filings.

EtQ Quality Management Software

EtQ's powerful, yet flexible and configurable software platform allows you to achieve compliance in Quality Assurance, Health & Safety Management, Corrective Action Tracking, Document Control, Reporting, Quality Management and Compliance Management and many more initiatives.

GainSeeker Suite

Hertzler Systems is introducing their newest product, QA/S GainSeeker® 7 Suite. Among the dozens of new features in the new release, noted highlights include: Additional security features such as enhanced 21 CFR Part 11 compliance.

DataThread, ROBAR, ROPICS, iSecurity

Innovatum products are developed using strict disciplines of validated systems in highly regulated industries. Consequently, the quality of our products exceeds accepted norms and can readily be validated within environments which currently enjoy that status.

PI system

Wonderware Intouch Active X Controls

For industries that do not require validation, all this means is that Innovatum products have passed the strictest quality assurance standards.

RSA Keon CA RSA Keon RA

Sentry CA provides a certificate issuance and management solution that enables global Public Key Infrastructure (PKI). Xcert Sentry allows pharmaceutical companies to meet 21 CFR Part 11 regulations and take advantage of the cost savings and conveniences that e-business brings.

Vlog Software

Completely tamper-proof, password-protected and secure, VL-series data loggers and vLog Software produce traceable high-accuracy documentation that meets the electronic record requirements of 21 CFR Part 11.

adWATCH

All of Winchester Business Systems' products and services comply with the requirements of the FDA's 21 CFR Part 11 for electronic signatures and electronic records using the ComPac software module.

Qstream iCompliance 5, Change Stream, DOCSTREAM

From the conception of a solution, to creation and delivery of content, Qstream iCompliance 4 provides the technical infrastructure necessary to build applications that must comply with 21 CFR Part 11 regulatory requirements. ChangeStream is a fully electronic Change Control Management Application to manage, track and consolidate under a single roof all activities pertaining to changes within a regulated environment.

NetRegulus NetRM™ Enterprise Software

NetRegulus NetRM™ Software is an exciting new approach to managing Study and Quality information. It is the only product that lets you link both Study and Quality data across the entire enterprise, allowing you to span product life cycles from pre-clinical studies to post market activities.

Secure Desktop 6.83

21 CFR Part 11 (FDA) - Secure Desktop has several features to aid the pharmaceutical, biotechnology, food, and beverage industries. Using Secure Desktop, program and data access can be controlled, user activity can be logged to disk, and users can be automatically logged off from Windows NT 4.0 or 2000 due to inactivity.

NovaGMP

Cimage NovaSoft GMP solves several major problems for pharmaceuticals manufacturing companies. The FDA requires manufacturers to adhere to Good Manufacturing Practice (GMP). With a Cimage NovaSoft solution you can easily establish, monitor and document quality, and demonstrate responsible decision making.