AVANTEVA SERVICES

We at Avanteva Solutions  (OPC) Pvt. Ltd., undertake the following services like Computer System Validation, Translational services and Courses & Trainings.

Computer System Validations (CSV)

As you know, all companies in the life sciences discipline must comply with CSV requirements, which are FDA mandates. Sometimes, even mega conglomerates are fined heavily for non-compliance. Understanding the vital aspects of CSV, Avanteva provides software validation services by creating a systematic and qualitative approach.

Avanteva Solutions brings you a thorough understanding of the regulatory requirements, as we possess rich exposure to regulatory guidelines such as Annex 11 for computer systems, 21CFR Part 11, GAMP 5. We maintain GxP standards to achieve compliance in above. 

 Computer System Validation is required for following department activities:

  • Manufacturing Automation Computer System/ Software; PLC’s, SCADA, HMI.
  • Laboratory Management System/Software; LMS, Computer System Associated with HPLC,GC,LCMS/MS,UV-VIS Spectrophotometry etc.,
  • Laboratory Calculation Related Software; Spread Sheet, SAS.
  • Batch Release and Other QMS System related Software; Batch Release Software, QMS Regarding Software, Labelling Software.
  • Production Monitoring Computer System/ Software; Material Management Software, Work Order management Software, Stock Order Management Software, Inventory Related Software.
  • Diagnostic related software’s; ECG,X-ray equipment related software’s.
Software validation Services by Avanteva

Project Highlights

  • Tailored Validation Strategies: Individually crafted for each project, our validation strategies are meticulously aligned with your specific requirements, guaranteeing adherence to regulatory standards.
  • Unique Project Validation Plans: We conceptualize exclusive validation plans for every Computer System Validation (CSV) project, ensuring an approach as distinctive as your systems.
  • Ensuring Regulatory Compliance: Our CSV protocols seamlessly integrate USFDA 21 CFR Part 11 guidelines within the framework of ISPE GAMP5 approach, securing your compliance with precision.
  •  Comprehensive Documentation: Our support spans the entire spectrum. Our comprehensive documentation encompasses the entire validation lifecycle, from the initial Project Validation Plan (PVP) to the conclusive Validation Summary & Report (VSR).
  • Risk Management: We navigate the intricacies of risk management with expertise, ensuring potential vulnerabilities are expertly addressed.
  • GAP Analysis: Exclusive GAP Assessment projects to Uncover hidden gaps in your laboratory computer systems/ equipment’s
  • In-house Excel sheet Design, Development Experts (for Spreadsheet Validations)
  • Fast Track Projects: We offer streamlined approach to project execution, leveraging our industry expertise to expedite validation activities without compromising quality or compliance.
  • Project Tracker: An exclusive Project Tracker web sheet for every client is created and shared with every customer to monitor the progress of the ongoing validation project, which helps ensure clarity among all department personnel involved in the project.

List of CSV Services

  • Computerized System Validation (CSV)
  •  Process Controlled System Validation (PLC/SCADA Validations)
  • Gap Analysis
  • ER-ES Assessment (21 CFR Part 11 Compliance Assessment)
  • Excel sheet Design, Development (ESD) & Excel sheet/Spreadsheet Validation (ESV)
  • Network/Server Validation
  • Validation of Web-based Applications
  • Mobile Tablets for manufacturing facilities
  • Mobile Medical Applications
Note: All the above services offered to life science industries by incorporating the guidelines outlined in the USFDA 21 CFR Part 11 and adhering to the procedural framework articulated by the ISPE GAMP5 V- methodology


Translational services

 

Here at “Avanteva Solutions  (OPC) Pvt. Ltd.” we do clinical translations where we translate clinical research documents into multiple languages like Western and Eastern Europe, Asia, South America, and the Middle East.

 

Background & Scope

  • Translation is needed at several stages right from bringing a drug molecule to the market includes manufacturing, marketing, packaging, clinical research, and regulatory submissions.
  • A significant and ever-increasing proportion of clinical research related work concerning clinical trials are performed in different countries and most of the drugs which are marketed are synthesized and manufactured abroad. Also, there is a growing demand for translations of clinical related documents in particularly to promote minor participation in clinical trials.
  • Translation of clinical related documents requires grammatical expertise as well as strong comprehension skills. This will be done by language experts. Our team are language experts and are certified professionals who could be able to give accurate translations. We translate all kinds of fields who are into clinical or non-clinical backgrounds.
  • We are highly professional and committed to delivering our translation services.
  • Clients can avail our services at very affordable prices and we promise you to deliver the services in defined expected timelines.

Type of Documents Translated 

  • Informed Consent Forms/Documents (ICF/ICD)
  • Subject Dairies (SD)
  • Patient Information Leaflets (PIL)
  • Clinical Study Protocols
  • Patient Diaries/Reports/Questionnaires
  • Trial Close-Out Monitoring Reports
  • Patent Applications
  • Case Report Forms (CRF)
  • Clinical Study Report Forms
  • Doctor And Patient Guides
  • SOP’s/Patents/Manuals/Labels/Inserts
  • User Manuals For Medical Devices/User Guides For
  • Medical Software
  • Clinical Study Agreement & Contracts
  • Pharmacovigilance Reports
  • Drug Development Process Documentation
  • Adverse Events Related Documents
  • Patient Education Materials etc.,

  • We have a strong network in India as we have native local translators with industry experience and hence we able to deliver accurate translations.
  • We deliver the submissions in-time and we make sure that accurate and real translations happen in every project.
  • Our team are experts and certified translators who has plethora of skills in the translation business and does translations with no scope of mistakes.
  • Preserving the original content and the intention of the author’s document in the translated form to let the readers easily relate to the author’s true intentions is the core of our work.

 

Industries We Serve

  • Pharmaceutical Companies 
  • Contract Research Organizations (CRO’s)
  • Medical Device Companies

Courses and Trainings

  • Welcome to our comprehensive range of pharmaceutical courses and trainings designed to enhance your expertise and proficiency in the dynamic field of pharmaceutical sciences. Whether you’re a seasoned professional or new to the industry, our courses cater to diverse levels of experience and specialization. 
  • For ‘Courses & Trainings’ – Contact Email: info@avanteva.org