Projeca

Provides compliance with government and regulatory regulations such as FDA 21 CFR Part 11

Gould Life Science Suite

Data Security -An optional Data Security feature provides compliance to FDA 21 CFR part11

Argus Safety Easy Trak

Argus Safety ™ Features: 21 CFR Part 11 Compliant ICH E2B - Electronic Submission ICH E2C - PSUR Compliant with current MedDRA™ versions CIOMS V EasyTrak ™ Features: 21 CFR Part 11 Compliant Meets FDA complaint handling requirements Integrated adverse-event reporting for FDA and EU Device Vigilance Reporting Return Goods Authorization Alternate Summary Report

Sample Guardian

Software Associates International,® LLC (SAI), is a leading provider of innovative and practical information-processing solutions that meet the specific sales and marketing needs of the Life Sciences industry. SAI has demonstrated the existence of adequate procedures and controls within Sample Guardian™, which are designed to ensure the authenticity and integrity of electronic records utilized to meet requirements of the PDMA. In addition, SAI implements extensive documentation outlining their processes and procedures. It is PDMA, Inc.'s regulatory opinion that Sample Guardian complies with the requirements 21 CFR Part 11 pertaining to closed systems.

cCure 800 security management platform

Software House Enterprise Solutions has years of experience building software solutions for the pharmaceutical industry. Some of our systems have been validated, and all of our work is done according to the high standards maintained in this demanding, regulated environment. Based on our own internal SOP's, our systems are built to comply with 21CFR11 (when required), with full implementation of electronic signatures.

TrustedTime

Trusted Time is a solution for providing the necessary components to meet the e-business need for secure and non-repudiatable time stamps. It is comprised of two main concepts: the security of the time stamp and the auditability of the time stamp. The security aspect addresses both the transmission of the time from a National Measurement Institute to the local time stamp system and the protection of time and audit information within any of the systems that the time stamp may reside in along the way. The audit nature of Trusted Time is the storing of time source and cryptographic information within each time component and the PKIX-compliant time stamp itself.

DataPro/DataGuard

Ionics Instrument Business Group (formerly Sievers Instruments) makes the world's most sensitive and selective scientific instruments to measure total organic carbon (TOC) for the pharmaceutical, semiconductor and power industries. A 21 CFR 11 compliant Sievers brand TOC system is available with a new DataPro/DataGuard software package that includes audit trails, electronic signatures and user-level security.

TOCTalk V3.5 For Phoenix 8000

TOCTalk Version 3.5 combined with the reliable, high-throughput Phoenix 8000 TOC Analyzer is the ideal solution for today's Pharmaceutical water for injection (WFI) and clean in place (CIP) applications.

Training Tracker III

The Food and Drug Administration (FDA) mandates strict regulations regarding electronic signatures and audit trailing on electronic data collection methods under 21 CFR Part 11. Healthcare manufacturers using electronic record-keeping systems must comply with stringent regulations regarding the training of their employees, including the methods of recording and reporting such training for audits. Training Tracker III helps companies stay in compliance with these regulations by tracking employee training records and cross-referencing employees with their job titles / grades, courses required for those jobs, instructors and course scheduling. Once an employee's training has been completed, the information is recorded with the electronic signature, and all changes to that record are also date- and time-stamped for auditing purposes.

ISOTrain

ISOtrain is a compliance driven training management software that meets government regulations, ISO 9000 standards and comprehensive validation protocols for a total quality based training. It has been developed based on industry reactions to government inspection observations (FDA, OSHA, EPA, etc.), 483's citations, and current or future client's requirements. Yes, ISOtrain is 21 CFR Part 11 compliant!

Isotrain Training Management Solution

ISOtrain Training Management Solution is a powerful compliance driven, quality based training tracking system. ISOtrain allows you to manage employee training records on your global network. With a click of a button, you can notify employees of scheduled training, e-mail a report to management, review employee qualifications, or retrieve a course outline. ISOtrain runs on multiple desktop platforms, network operating systems and databases. Validation is made easy with a comprehensive validation package.

TVM(The Validation Manager)

We are on the verge of launching version 2.0 of TVM that is our own Windows-based software package offering an expert knowledgebase of compliance and regulatory information to assist with every kind of validation project. Using The Validation Manager can greatly reduce the cost and complexity of managing validation projects thanks to the unique use of a Tractability Matrix and OneClick preparation of validation TVM also designed to be fully compliant with 21CFR part 11

INDexxis

INDexxis™ is designed to manage data in accordance with predicate rules (GxP) and the new regulations on electronic records and electronic signatures, especially FDA 21CFRpart11.

SmartSolve

Pilgrim’s solutions help you effectively manage corrective and preventive actions (CAPA), investigations, customer complaints, internal and external assessments, document control, supplier quality, equipment calibration and maintenance, and employee training to help you produce the best products at the lowest cost.

DocsMinder

Docsminder is powerful yet simple to use Windows based software specifically designed for the effective and efficient management of hard copy documentation throughout its entire life cycle, from the moment of creation through to ultimate disposal.

Info-Organiser

Info-Organiser is a windows based electronic filing system than allows you to store all your business files, both paper and electronic, in a central location, that is indexed for easy retrieval.

DocuXplorer

DocuXplorer offers affordable document management systems that give any size business the ability to quickly find, share and access all document types, both scanned in paper and electronic computer-generated files, from one easy-to-use desktop screen.DocuXplorer Enterprise provides users with a full set of features including; Document Capture, Library Functions, Versions, Audit Trail, Annotation, Viewing, Security, Communication, PDF Print Capture, Integration with Microsoft Office, and extended database, display and reporting features not found in other document management applications.

Aspentech

Aspen Technology, Inc, is the leading supplier of integrated software and solutions that enable process manufacturers to automate and optimise their plants and extended supply chains while enabling e-Business. AspenTech offers the industry's broadest family of scaleable solutions allowing our customers to be successful in the Internet economy.

MasterControl™

MasterControl™ integrated QUALITY and COMPLIANCE management software systems for FDA and ISO regulated industries. Integrated software systems include CAPA, Document Control, Training Management / Tracking, Change Control, Audits, Complaints Handling, eProcess Automation, Sarbanes-Oxley (SOX), etc.

PFS Suite

PFS-Suite is intended to facilitate the engineering activities involved in automation software.