A Perfect Solution For Your Business

We are a team of specialists to Develop, Test and Validate Applications, Systems and Software’s.

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About Us

Our Validation Experts Can Help Your Project at Any Stage.

  • Computer System Validation
  • Computer System Compliance
  • Data Integrity
  • Training

WHO WE ARE

Trijal Validation Services consultants have extensive Life Sciences, pharmaceutical, biotech, medical device, and software industry experience. They provide leadership to companies seeking to meet FDA, EMA, MHRA, and other agency expectations.

We'll ensure the success of your next software project. Implement our proven validation methodology and be confident that your processes are compliant.Our validation experts can help you prepare before that FDA audit. We know all of the common pitfalls and will help you avoid a failed audit.

WHAT WE DO

We will ensure that your validation complies with FDA, EMA, MHRA, and other agency regulations:

  • Our validation experts bring a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report
  • Perform system Risk Assessment
  • Develop a Validation Plan that is appropriate for the system risk level.
  • Work with your team to document User Requirements and Functional Specifications.
  • Develop Test Plans and Deliver Validation Protocols (i.e., IQ, OQ, PQ).
  • Execute the Validation Protocols and provide supporting test documentation.
  • Deliver inspections ready Test Summary and Validation Report.

Our validation professionals can work with you either at your site or remotely – whichever fits your needs and budget.


Validation Services

We deliver a customer approach to computer system validation (CSV) and software quality assurance (SQA). We can deliver a new validation program or simply target those areas where you need additional help.Our consultants have extensive pharmaceutical, biotech, medical device, and software industry experience. They provide leadership to companies seeking to meet FDA, EMA, MHRA, and other agency expectations.

Validation Services

We can validate for you. Whether you are short on time or expertise, our experienced software validation project managers and engineers are available to get your validation project finished on time.

CSV & CSA Programs

Ensure the success of your validation projects… before you begin. Our consultants can help you implement a proven validation methodology and prepare your staff to use the latest computer system validation (CSV) and computer software assurance (CSA) techniques.

Validation Process Improvement

If you know that your approach to software validation could be more efficient or more compliant, our consultants can help you identify process improvements and incorporate risk-based practices into your methodology.

Equipment, Facilities, Utilities Qualification

Know that your equipment is operating properly and that it meets both user and product-requirement specifications. Qualification testing provides you with this assurance.

“Computer systems validation (CSV) is a critical requirement from the regulatory perspective (U.S. FDA, EMA e.t.c). The validation process is designed to provide a high degree of assurance that both new and existing computer systems will consistently fulfill their intended purpose by producing results which meet predetermined specifications and quality attributes – accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

As Life Sciences applications constantly evolve to keep up with the needs of the people and businesses that use them, Life Science companies must perform validation activities on an ongoing basis in order to reduce compliance risk, ensure quality, and maintain data integrity.A “Computer System” in an FDA regulated laboratory is more than just computer hardware and software – it also includes any equipment and instruments linked to the system, as well as the trained staff that operate the system and/or equipment using Standard Operating Procedures (SOPs) and manuals. Computer system validation requires a comprehensive set of both static and dynamic testing activities that must be conducted throughout the Software Document Life Cycle (SDLC)

At Trijal Validation Services, we are experts in IT risk identification and management along with regulatory compliance. As such, we understand that computer system validation is not a “one size fits all” process. With over 20 years of validation experience, we work to create CSV processes that are based on the latest FDA regulations and guidance (GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems), best practices, and the characteristics of the system being validated.

Key Validation Documents:

  • Validation Master Plans (VMP)
  • Validation Plans (VP)
  • Risk Assessment (RA)
  • User Requirement Specifications (User Specs, URS)
  • Functional Requirements (Functional Requirement Specifications, Functional Specs, FRS, FS)
  • Design Specification (DS)
  • Test Plan / Test Protocol
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requirements Traceability Matrix (Trace Matrix, RTM, TM)
  • Protocol Test Deviations
  • Validation Summary Report (Validation Report, Summary Report, VR, SR)
  • Change Control for Validated Systems
  • Part 11 Training
  • Auditing and Assessments

Computer System Compliance

Compliance with FDA 21 CFR 11 Electronic Records; Electronic Signature and EU Annex 11 Computerised Systems is a must for the pharmaceutical, biotech, medical device, and clinical research industries.Whether you need to get into compliance with Part 11 and Annex 11, provide verification of compliance, or simply ensure that your IT vendors are compliant, we can help.

Part 11 and Annex 11 Gap Assessments

When you have an important upcoming inspection or customer audit, we can conduct a Part 11 or Annex 11 Gap Assessment to let you know where your systems are compliant and where they’re not.

Part 11 and Annex 11 Compliance

If your organization’s growth depends on compliance with Part 11 or Annex 11, we have the experts you need to get your systems, procedures, validation documents, and employees ready.

Compliance Verification Audits

Need independent verification of compliance with key regulations such as Part 11 and Annex 11? We can audit your systems, processes, and records to provide an objective certification to share with your customers.

IT Vendor Audits

Regulators require organization to assess and approve suppliers of critical IT infrastructure and software applications. Hire an experienced, certified auditor to audit IT providers on your behalf.

Data Integrity

Data Integrity is greatly important because data without integrity puts our patients at risk. Data Integrity is a ‘hot topic’ because many of the standard controls implemented decades ago for paper records, have not yet been implemented for electronic records and computer systems.

Data Integrity Gap Assessments

If you haven’t thought about data integrity before now, the best place to start is with a Gap Assessment. This will let you know where current systems and practices are already ensuring data integrity and where there are gaps to address.

Data Integrity Policies and Procedures

One of the first steps in ensuring data integrity is the implementation of a Data Integrity Policy and the development of procedures to embed data integrity best-practices into daily activities.

Data Governance Programs

As your data integrity practices mature, a Governance Program will ensure ongoing compliance and provide a forum for continuous improvements.

Training

Whether you are new to validation or an experienced pro, our software validation training courses and webinars will give you the insight, tools, and techniques that you need for validation success.

Our computer system validation experts have developed educational courses and webinars to help you apply the FDA, ICH, and Eudralex risk-based validation concepts to your projects. This allows you to maximize the impact of your compliance and quality efforts. Our courses also incorporate industry standards and best practices, such as those found in PIC/S and GAMP.

List of Courses

  • 01 Computer System Validation Boot Camp

    Computer System Validation Boot Camp focuses on building expertise and critical thinking skills in computer system validation through immersion in the regulations, focused class activities, and hands-on practice authoring validation documents.

  • In this course you get insights on the latest developments in Data Integrity with more than just lectures. Our instructors share real-life examples and exercises designed to ensure you set up a data governance framework that meets regulatory expectations.

  • Computer System Validation for Cloud and COTS Applications mixes instructor lectures with real-world examples. You leave with the knowledge and understanding of CSV processes, deliverables, and regulatory expectations needed to lead projects for validation of purchased systems.

  • you can gain awareness of the essential elements of computer system validation, including 21 CFR Part 11, by attending our Introduction to Computer System Validation class.

 

Contact

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Location:

Flat #102, Suvarna Enclave, JNTU,
Hyderabad- 500085

Call:

040 4709 8805
+91 628 168 2726

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