Validation

SnapMD Completes SOC 2 and HITRUST Examinations of Health Data Security and Controls

Retrieved on: 
Wednesday, August 7, 2019
Articles, Health, HITRUST, Health Insurance Portability and Accountability Act, Regulatory compliance, Audit, Telehealth, Validation

By achieving SOC 2 and HITRUST compliance, SnapMD demonstrates that third-party auditors have verified its implementation of best practices with respect to data security processes and controls.

Key Points: 
  • By achieving SOC 2 and HITRUST compliance, SnapMD demonstrates that third-party auditors have verified its implementation of best practices with respect to data security processes and controls.
  • "Adding SOC 2 and HITRUST compliance reports to our already robust HIPAA compliance activities confirms SnapMD's commitment to safeguarding protected health information through our Virtual Care Management telehealth platform," explains George Tierney, co-founder and COO, SnapMD.
  • We recognize that sensitive patient health data should always be protected with the utmost security in a safe and compliant manner and we're proud to achieve this validation."
  • As part of SnapMD's pledge to security, the company will continue to perform examinations on an annual basis with a licensed CPA firm.

ANI Pharmaceuticals Reports Second Quarter Results

Retrieved on: 
Wednesday, August 7, 2019
Health, Articles, Pharmaceuticals policy, Pharmaceutical industry, Quality, Pharmaceutical industry in China, Pharmacy in China, Science and technology in the People's Republic of China, Validation

ANI expects to complete API process validation and registration stability batch manufacturing in the third quarter of 2019.

Key Points: 
  • ANI expects to complete API process validation and registration stability batch manufacturing in the third quarter of 2019.
  • ANI intends to complete the third and final registration batch of drug product in the third quarter of 2019.
  • ANI remains on track to file a supplemental NDA in the first quarter of 2020.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals.

Synopsys to Acquire QTronic GmbH

Retrieved on: 
Tuesday, August 6, 2019
Hillsboro, Oregon, Synopsys, SEC filings, Mentor Graphics, Form 10-Q, Validation, Companies, Articles, Economy of the United States

The transaction is subject to customary closing conditions, including certain foreign regulatory filings, and is expected to close in Synopsys' fourth quarter of fiscal year 2019.

Key Points: 
  • The transaction is subject to customary closing conditions, including certain foreign regulatory filings, and is expected to close in Synopsys' fourth quarter of fiscal year 2019.
  • The terms of the deal, which is not material to Synopsys financials, are not being disclosed.
  • QTronic GmbH, established 2006, is a leading provider of tools for virtual validation of automotive software.
  • Other risks and uncertainties that may apply are set forth in the Risk Factors section of Synopsys' most recently filed Quarterly Report on Form 10-Q.

ISPE Brings Quality Pharma Manufacturing to the Forefront in Asia Pacific

Retrieved on: 
Thursday, August 1, 2019
Health, Articles, Clinical research, Clinical data management, Quality, Validation, Validity, Pharmaceutical industry, Good automated manufacturing practice, International Society for Pharmacoepidemiology

BETHESDA, Md., Aug. 1, 2019 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference taking place 2627 September in Bangalore, India, and the inaugural 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference taking place 30 September1 October in Singapore.

Key Points: 
  • BETHESDA, Md., Aug. 1, 2019 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference taking place 2627 September in Bangalore, India, and the inaugural 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference taking place 30 September1 October in Singapore.
  • "Attendees will hear from regulators and industry as they discuss critical topics including, process validation, data integrity, and innovative approaches to ensure compliance with regulatory expectations," said Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA, program committee member for the 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference and program chair for the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference.
  • The inaugural 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference in Singapore will be a comprehensive event that focuses on new strategies, innovations, and developments in the fields of quality and compliance.
  • The 2019 ISPE South Asia Pharmaceutical Manufacturing Conference in Bangalore will focus on the product lifecycle approach from drug development to post-market approvals.

Bioprocess Validation Market Worth $ 360 Million by 2024 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Thursday, August 1, 2019
Pharmaceutical industry, Validity, Clinical data management, Clinical research, Quality, Validation, Articles, Business

Additionally, automation in bioprocess validation services and geographic expansions by market players are the upcoming trends in bioprocess validation, which also expected to support market growth in the coming years.

Key Points: 
  • Additionally, automation in bioprocess validation services and geographic expansions by market players are the upcoming trends in bioprocess validation, which also expected to support market growth in the coming years.
  • Extractables/leachables testing services segment to account for the largest share of the bioprocess validation market, by test type
    The extractables/leachables testing services segment is expected to account for the largest share of the bioprocess validation market in 2019.
  • Among all end-user segments, the demand for bioprocess validation is estimated to grow at the highest rate among CDMOs.
  • Get 10% Customization on this report:
    North America is expected to account for the largest share of the bioprocess validation market in 2019, closely followed by Europe.

Bioprocess Validation Market Worth $ 360 Million by 2024 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Thursday, August 1, 2019
Pharmaceutical industry, Validity, Clinical data management, Clinical research, Quality, Validation, Articles, Business

Additionally, automation in bioprocess validation services and geographic expansions by market players are the upcoming trends in bioprocess validation, which also expected to support market growth in the coming years.

Key Points: 
  • Additionally, automation in bioprocess validation services and geographic expansions by market players are the upcoming trends in bioprocess validation, which also expected to support market growth in the coming years.
  • Extractables/leachables testing services segment to account for the largest share of the bioprocess validation market, by test type
    The extractables/leachables testing services segment is expected to account for the largest share of the bioprocess validation market in 2019.
  • Among all end-user segments, the demand for bioprocess validation is estimated to grow at the highest rate among CDMOs.
  • Get 10% Customization on this report:
    North America is expected to account for the largest share of the bioprocess validation market in 2019, closely followed by Europe.

Leading Human Factors Scientists from MAURO Usability Science Identify Problems in FDA Medical Device Design Guidance and Human Factors Engineering Validation Criteria That May Be Contributing to Patient Use Errors and Adverse Events

Retrieved on: 
Thursday, July 25, 2019
Health, Articles, Pharmaceutical industry, Validity, Clinical data management, Clinical research, Quality, Validation, HFE, Medical device, Food and Drug Administration

There is also indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations.

Key Points: 
  • There is also indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations.
  • This may lead medical devices that pass FDA HFE validation to still exhibit significant use errors when utilized by actual patients in the real world.
  • They recently published their findings in a paper that links possible sources of HFE performance problems with medical devices to HFE validation methodologies within the FDA HFE guidance framework.
  • Their paper also examines device design teams' failure to utilize HFE best practices in the design and testing of medical devices.

YuJa Announces Completion of SOC 2 Audit Certification

Retrieved on: 
Wednesday, July 24, 2019
Articles, Citrus, Korean cuisine, Yuzu, Validation, Professional certification, Health, Evaluation

SAN JOSE, Calif., July 24, 2019 /PRNewswire/ -- YuJa, a leader in enterprise video solutions, today announces it has successfully completed its Service Organization Control (SOC) 2 Type 1 certification.

Key Points: 
  • SAN JOSE, Calif., July 24, 2019 /PRNewswire/ -- YuJa, a leader in enterprise video solutions, today announces it has successfully completed its Service Organization Control (SOC) 2 Type 1 certification.
  • Both SOC 2and EU-US Privacy Shield certifications require YuJa to maintain certain safeguards for data.
  • In achieving Type 1 certification, an independent third-party auditor has validated the design of YuJa's governance controls.
  • Our SOC 2 certification demonstrates not only our company's commitment to upholding these standards, but also provides an external validation of this commitment," said Dr. Ajit Singh, President of YuJa Inc.
    YuJa is a leader in enterprise video solutions.

Photobiostimulation Devices Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019 - 2027

Retrieved on: 
Thursday, July 18, 2019
Clinical data management, Clinical research, Pharmaceutical industry, Quality, Validation, Validity, Articles, Business, Evaluation

The report presents comprehensive information on how various opportunities will appear for the photobiostimulation devices market during the period of 2019-2027.

Key Points: 
  • The report presents comprehensive information on how various opportunities will appear for the photobiostimulation devices market during the period of 2019-2027.
  • This report encompasses exhaustive data pertaining to the segment-wise trends in the photobiostimulation devices market.
  • The information mentioned in the photobiostimulation devices market report answers salient questions for currently operating market players as well as the ones eying entry into photobiostimulation devices market, to assist them build winning growth strategies and take correct business decisions related to the market.
  • The report on the photobiostimulation devices market has also passed through cross-validation to make sure that the photobiostimulation devices market report is unique and one-of-its-kind, with the highest possible credibility.

NASA Awards IV&V Management and Communications Support 2 Contract

Retrieved on: 
Monday, July 15, 2019
Business, Articles, Economy, Software quality, Software testing, Software verification and validation, NASA, Validation, Consultant, Greenbelt, Maryland

GREENBELT, Md., July 15, 2019 /PRNewswire/ --NASA has awarded a contract to TI Verbatim Consulting, Parkersburg, West Virginia, for Independent Verification and Validation (IV&V) Management and Communications Support.

Key Points: 
  • GREENBELT, Md., July 15, 2019 /PRNewswire/ --NASA has awarded a contract to TI Verbatim Consulting, Parkersburg, West Virginia, for Independent Verification and Validation (IV&V) Management and Communications Support.
  • The contractor is Small Business Administration 8(a) certified and is a 100% Minority and Economically Disadvantaged Women Owned Small Business.
  • The one-year firm fixed price contract has a value of $658,039 and four one-year options to extend the period of performance to July 2024.
  • TI Verbatim Consulting will provide administrative and technical services including strategic communications support, knowledge management, events, website support, and metrics to assist the IV&V Program in meeting its mission for NASA.