Pharmaceutical Validation Services

Syntricate Technologies LLC is dedicated towards providing high quality and personalized validation services to our Pharmaceutical and healthcare clients. We offer full spectrum of services such as Computer System Validation, Performing Quality Audits, Commissioning or Decommissioning of software, Cleaning Validation, Equipment Validations, Process Validation for our clients.

 

Validation is an essential process in Pharmaceutical and Healthcare industry to ensure that the products being developed are high quality, cost effective and as per FDA regulations. Syntricate Technologies aspires towards providing superior services and support in a consistent and cost-effective manner. Our team consists of highly dedicated, experienced technical and personnel resources providing validation efforts to meet our client’s expectations.

 

At Syntricate Technologies, we organize seminars, training and workshops to add new skills among our resources and making sure that they are well informed and cognizant to the industries best practices. We have the expertise in executing long term projects as well as projects running under time crunch. We provide end-to-end client support and offer maximum success and satisfaction to our clients.

For more information, contact us now

For more information, contact us now

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GxP and GxP Consulting Services

  • Reduce effort to achieve and maintain compliance

  • Identify potential failures and risks at an early stage

  • Establish corrective measures and actions

  • Benefit from new techniques and innovations

  • Establish effective procedures for change and configuration management

  • Procedures to assure cost-effective operation and maintenance

PHARMACEUTICAL

  • Computer System Validation

  • Process validation

  • 21 CFR Part 11, 50, 56, 58, 210,211,820

  • Cleaning Validation

  • Equipment Validation

  • GxP Standard

  • Drug discovery and development

  • Validation Master Plans

  • Risk Assessment and Mitigation

  • IQ/OQ/PQ Protocols

  • Validation Reports

  • SOP Development and Review

  • Gap Analysis and Remediation

  • FDA regulatory compliance

CLINICAL AND LAB SOFTWARE SYSTEMS

  • Clinical Trial Management System

  • Laboratory Information Management System

  • EDMS

  • SharePoint

  • Clinical Data Management System

  • Adverse Event Reporting System

  • Enterprise Resource Planning System

HEALTHCARE

  • Insurance-HMO, PP0, POS

  • Obamacare (PPACA)

  • Electronic Health Records

  • Electronic Medical Records

  • Medicare

  • Medicaid

  • ICD-9-CM

  • ICD -10-CM

  • 4010 and 5010 compliance

  • EDI Standards- 837, 835, 270,

  • 271, 276, 277, 820, 834

  • HIPAA Transactions

  • Healthcare Reforms