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Electronic Medical Records (EMR) for the Health Care Industry
Electronic Medical Records (EMR) for the Health Care Industry
Electronic Medical Records (EMR) assists physicians and other clinicians document patient care for current visits and provides access to patient clinical history. Sometimes may be referred to as co...
 

 medical fda compliant


Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance
The US Food and Drug Administration (FDA) requires pharmaceuticals and medical device companies to comply with numerous standards. Medical device manufacturers

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Regulatory and Compliance RFI/RFP Template

Design for Compliance, Management of Hazardous and Controlled Substances, Regulatory and Compliance Documentation, Managing Recyclables and Controlled Waste, Product Technology Get this template

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Start evaluating software now

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Electronic Medical Records (EMR) for the Health Care Industry
Electronic Medical Records (EMR) for the Health Care Industry
Electronic Medical Records (EMR) assists physicians and other clinicians document patient care for current visits and provides access to patient clinical history. Sometimes may be referred to as co...

Documents related to » medical fda compliant

PTC Submits Test Data to FDA’s Global UDI Database


Working with the FDA and major medical device manufacturers, PTC has developed a Global Unique Device Identifier Database (GUDID) submission solution that such manufacturers can use to facilitate compliance requirements submissions. Get the details from P.J.'s post.

medical fda compliant  the software content of medical devices increases, companies must now also consider developing software patches for such devices.   PTC worked with the FDA and major medical device manufacturers to develop a GUDID submission solution. Built on the PTC Windchill product lifecycle management (PLM) platform, the PTC UDI solution is a preconfigured software solution, validated in accordance with 21 CFR Part 11 requirements, designed to help medical device manufacturers meet the needs of UDI submissions as Read More

Not Yet Sold on SaaS ERP in Manufacturing? Take a Hard Look at Plex Online - Part 2


Part 1 of this blog series explained Plex Systems’ ebullience and growth despite a hostile and depressed environment, especially in the discrete manufacturing sector. While the software-as-a-service (SaaS) model is now mainstream in many functional areas of business, the article concurred with Frank Scavo’s recent assertion that, for the time being, there is only one true SaaS enterprise resource

medical fda compliant  Hunky-dory Yet However, the medical devices and life sciences industry might not be yet ready to jump on the SaaS bandwagon due to the  US Food and Drug Administration’s (FDA)  regulatory and  validation  requirements. There has been no FDA guidance issued on SaaS yet. Other issues and caveats would stem from the dubious validation of software that is outside the manufacturer’s physical control in spite of the additional power and accessibility of a SaaS system. SaaS applications must be built Read More

The Best-kept Secret in the Product Lifecycle Management Mid-market


The name Omnify Software may hardly come to mind when one thinks of the product lifecycle management (PLM) leaders, but that might change down the track

medical fda compliant  compliance requirements are causing medical manufacturers to shy away from hosted solutions. Namely, these regulations call for adherence to specific processes and data sets when using automated or electronic systems. They also have an impact on how customers need to test and validate the software they use to help build their products. Unfortunately, these validation processes add yet another layer of complexity to SaaS systems since customers will need to go through a validation process before they are Read More

Mid-Market Strategy: International Enterprise Solutions


Adonix marks its strategy with two catchwords: "growth" and "independence". It has carefully assessed and added acquisitions to broaden Adonix X3 suite's functional scope, licenses and services; and continues nurture internal development with its own resources.

medical fda compliant  & Company (pharmaceuticals), UreSil (medical devices), Teikoku Pharma USA , and GS Cosmeceuticals (skin care). Some customers are notable multinational corporations, such as L'Oreal and L'Occitane (luxury goods), Sofradim (medical devices) and Stockmeier Urethanes . However, as no one can be all things to all people, Adonix uses a number of value-adding partnerships, such as the incorporation of the MSDS capability in conjunction with The Wercs , financial reporting from FRx Corporation (part of Read More

ArticSoft FileAssurity


Low cost file, folder and e-mail encryption and digital signature software. Secure file deletion above and beyond US Government DOD standards. Secure archives, certificate and key generation, and free reader software. FileAssurity is Open-PGP compliant and will import and generate PGP format keys, and encrypt/decrypt, sign/verify PGP compliant files. FileAssurity provides Government grade security without the complexity of other encryption products.

medical fda compliant  ssl disadvantages articsoft,articsoft ltd.,articsoft fileassurity crack,ssl disadvantages articsoft,articsoft ltd.,articsoft fileassurity crack Read More

ERP System for Health Care


A U.S.-based regional healthcare support network was looking for a distribution enterprise resource planning (ERP for distribution) solution for its medical supply and equipment sales division, including a financials module to be used by other divisions. The news system was intended to replace an in-house legacy system that had reached its end-of-life stage.
To find the right solution, the company turned to TEC for a software evaluation and selection project.
Starting with a list of 10 qualified solutions, TEC issued requests for information (RFIs) to each of the vendors. Based on the RFI responses, the company was able to compare the 10 solutions and develop a shortlist of the four most promising ones for in-depth evaluation.
TEC also helped the company collect market data, and prepare scripts for a formal demonstration session—a key component of the final selection process.



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Sarbanes-Oxley Compliant Data Protection


The Sarbanes-Oxley Act (SOX) regulates the storage and management of corporate financial data for all Registered Public Accounting Firms and many publicly held companies. Which SOX regulations affect data backup in your company—and how can a remote data backup solution help you comply? Find out, with an explanation of various sections of the SOX act, matched with key remote data backup functionality.

medical fda compliant   Read More

ERP Issues for the Midsized Life Sciences Company


What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.

medical fda compliant  ISO-9001 quality document. The medical devices GMPs were then renamed to the Quality System Regulation (QSR) . Changes also come about through the evolving expectations of inspectors. In the U.S., these changes are communicated through agency guides and guidelines and by presentations and papers presented by FDA personnel. More informally, cGMPs evolve as new practices become feasible and valuable. One other way industry personnel can keep track of changes in expectations is by watching the FDA-483s Read More

Case Study: All Flex Inc.


From its two locations, All Flex serves industrial, medical, and other customers with printed circuits. Five years ago, All Flex kept its records in multiple, inconsistently updated spreadsheets—leading to parts shortages and production delays. With an enterprise resource planning (ERP) system designed for the printed circuit industry, All Flex increased sales and reduced delays to less than 1 percent. Find out how.

medical fda compliant  All Flex serves industrial, medical, and other customers with printed circuits. Five years ago, All Flex kept its records in multiple, inconsistently updated spreadsheets—leading to parts shortages and production delays. With an enterprise resource planning (ERP) system designed for the printed circuit industry, All Flex increased sales and reduced delays to less than 1 percent. Find out how. Read More

Mercury Medical: A Health Care Manufacturer Improves Reporting and Analysis with IBM Cognos Express


Read how Mercury’s users can now create the most critical reports that they were previously relying on a legacy reporting platform to produce. These include sales commissions, weekly sales, a rolling 12-month sales report, and an inventory summary report.

medical fda compliant  Medical: A Health Care Manufacturer Improves Reporting and Analysis with IBM Cognos Express Read how Mercury’s users can now create the most critical reports that they were previously relying on a legacy reporting platform to produce. These include sales commissions, weekly sales, a rolling 12-month sales report, and an inventory summary report. Read More

Philips and salesforce.com Team Up for Healthcare IT Cloud


Royal Philips and salesforce.com announced a strategic alliance in which they will work towards developing a new platform of cloud-based healthcare information technologies. The two parties plan to leverage Philips' expertise in medical technology, clinical applications, and clinical informatics, and salesforce.com's leadership in enterprise cloud computing and customer relationship management (CRM).

medical fda compliant  leverage Philips' expertise in medical technology, clinical applications, and clinical informatics, and salesforce.com's leadership in enterprise cloud computing and customer relationship management (CRM).   The envisioned platform, based on the Salesforce1 Platform with cloud, mobile, the Internet of Things (IoT), and social traits, will enable collaboration and workflow, allowing caregivers to collaborate closely in support of their patients. It will also facilitate integration of data from multiple Read More

The High Costs of Non-compliance for Manufacturers


What manufacturers must realize is that through efforts to comply with regulatory standards, they can make their manufacturing operations more competitive. Indeed, compliance is transforming the companies that have taken the time to re-architect the many processes used for managing suppliers, channel partners, resellers, and customers. For manufacturers that ignore compliance, on the other hand, the costs can be steep.

medical fda compliant  industrial tool Surgically implanted medical equipment Infected medical equipment at end-of-life Where Compliance Strategies Are Working The following sections provide insights into where compliance strategies are working, highlighting how manufacturers sometimes turn extensive process reengineering and high costs into a lasting competitive advantage and often, cost and efficiency advantages. Reorienting Supplier Relationships Toward Compliance Intel's many efforts at RoHS compliance has permeated their Read More

Does Android Dream of Enterprise Adoption?


Android is here to stay, especially as BYOD programs gain popularity. To remain secure and compliant with industry standards, enterprises need a way to protect and manage the wide range of available devices, versions, and idiosyncrasies of the world’s most popular mobile operating system. See how mobile device management (MDM) platforms can provide a stable universe for Android devices to be securely deployed in your workforce.

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Is Your Data Compliant? Electronic Recordkeeping Best Practices for the Financial Industry


Financial institutes are required to maintain and produce a variety of records related to their business activities, many of which exist in an electronic format. In order to satisfy the increasing number of regulatory mandates around electronic data, organizations should assess their regulatory obligations and streamline efforts to capture, maintain, identify, and produce these records to regulators. This white paper offers ten steps to guide organizations through this complex process.

medical fda compliant  electronic recordkeeping,data compliance,Globanet,financial recordkeeping best practices,recordkeeping software Read More