Unmatched Solutions Tailored for Regulatory Success
Elevate Compliance with CSV Mastery
Elevate your compliance game with our proven CSV mastery. Adhering to GAMP 5, 21 CFR Part 11, and EU Annexure 11, our tailored solutions ensure precision in every validation step. Experience excellence in a dynamic regulatory landscape.
Tailored Solutions
Crafting Your Success Journey
At Tech Qualitas, we recognize that every business is unique, facing distinct challenges that demand customized solutions. Our Tailored Solutions break away from one-size-fits-all approaches, offering a personalized journey to success.
In-Depth Understanding
Initiate the process with thorough consultations, allowing our experts to gain profound insights into your business intricacies, challenges, and industry-specific requirements.
Agile Implementation
Benefit from our agile implementation process, ensuring a seamless transition and continuous optimization to adapt to the dynamic business landscape.
Compliance Excellence
Trust in our commitment to compliance standards and explore real-world success stories, where businesses like yours have thrived through our tailored technological solutions. Connect with us to begin your journey to tailored excellence.
Data Integrity Solutions
Unlocking Data Assurance for Unparalleled Reliability
At Tech Qualitas, we understand the challenges businesses face in ensuring data integrity throughout its lifecycle. Our tailored Data Integrity Solutions address critical problems, providing swift and effective resolutions to your most pressing concerns.
Incomplete Data Traceability Resolved
Ensuring complete data traceability, our solutions seamlessly track and monitor data from inception to storage. Achieve unparalleled traceability and confidence in your data integrity.
Combat Data Accuracy Concerns
Tackle accuracy concerns head-on with our Data Integrity Solutions. Our robust frameworks and processes guarantee the accuracy of your data, ensuring reliability in every piece of information.
Detect and Rectify Data Anomalies:
Our solutions include advanced anomaly detection mechanisms, swiftly identifying and rectifying data irregularities. Stay ahead of potential discrepancies with Tech Qualitas.
Mitigate Risk of Unintentional Manipulation
Our cutting-edge measures mitigate the risk of unintentional data manipulation, providing a secure environment, safeguarding your data integrity and compliance.
Compliance Solutions
Navigating Compliance with Precision
In a dynamic regulatory landscape, ensuring the validation and compliance of computerized systems is paramount. Tech Qualitas specializes in providing top-notch Computerized System Validation (CSV) solutions, leveraging over 40 years of industry expertise to navigate the complexities of compliance frameworks seamlessly.
Thorough Audits
Conducting comprehensive audits, including Infrastructure and Cloud Compliance Audits, and Site Audits (including Inspection Ready Assessments and Pre-Approval Inspections).
Customized Compliance Solutions
Tailoring solutions to meet the specific compliance needs of your industry, ensuring precision and adherence to regulatory standards.
Regulatory Documentation Excellence
Ensuring meticulous documentation aligns seamlessly with regulatory requirements, providing a robust foundation for your compliance strategy.
Audit Solutions
Complete Audit Readiness for Operational Confidence
Preparing for audits shouldn’t be a daunting task. Tech Qualitas offers Audit Solutions that streamline the preparation process, providing real-time visibility and actionable insights to enhance your audit readiness.
Effective Corrective Action
Systems for swift corrective actions post-audits ensure prompt issue resolution, preventing recurring problems.
Real-Time Audit Visibility
Real-time audit process visibility enables quick decision-making and issue resolution. Enhance operational control and audit confidence.
Strategic Partnership
Tech Qualitas, your strategic partner, addresses pain points with precision, delivering transformative solutions for operational excellence. Explore our comprehensive offerings and elevate your operations.
CSV Solutions
Elevating Compliance for Seamless Operations
Harness the strength of Tech Qualitas’ 40 years of industry leadership with our Computerized System Validation (CSV) solutions. We streamline compliance for your systems, ensuring a harmonious blend of efficiency and adherence to industry standards.
- 21 CFR Part 11: Electronic Records; Electronic Signatures (ER/ES) compliance.
- ISPE GAMP5: Good Automated Manufacturing Practice for computerized systems.
- ICH E6 (R2): International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice.
- EU GMP Annexure 11: Computerized Systems.
- ISO Standards: Adherence to relevant International Organization for Standardization standards.
- FDA Regulations: Compliance with regulations set by the U.S. Food and Drug Administration.
- TGA: Compliance with the Therapeutic Goods Administration standards.
- Health Canada Regulations: Adherence to regulations outlined by Health Canada.
- EMA (European Medicines Agency): Ensuring compliance with European Medicines Agency standards.
- WHO Guidelines: Following guidelines set by the World Health Organization.
Contact Us
Get Expert Solutions Now!
Reach out to Tech Qualitas and explore bespoke technological solutions meticulously crafted to meet your business needs. Our team is ready to assist you on your journey towards operational excellence. Whether you have inquiries, need consultation, or are ready to initiate a collaboration, we’re here to help. Connect with us today and let’s navigate the path to success together.
Company Mail
info@techqualitas.com
Phone Number
+91 9625361687
