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UVJ Technologies

UVJ offers concept-to-market R&D and engineering services to optimise your product operations. Our Product Engineering services and Product Lifecycle Management (PLM) services address the complete engineering value chain, for the life science industries.

Our experts integrate people, data, processes and business systems and provide a product information backbone for companies and their extended enterprise.

We have partnered with major providers of software and services for discovery, analysis and collaboration of the life sciences and chemical industries, academia and government. Its integrated product suite improves the productivity of researchers in the discovery, development and commercialization of chemical and biological compounds. Products include Cloud, Enterprise, Workgroup and Desktop versions providing knowledge management, chemical and biological informatics and scientific database solutions.

  • Application Development
  • Offshore Software Services
  • Lab Automation Services
  • 21-CFR-Part II Compliant Software

Application Development

UVJ's application development services help you address evolving business and technology challenges by defining, designing and building applications tailored to meet your business requirements. We deliver high-quality, flexible applications that are easy to maintain; modular to facilitate enhancements and are reliable, secure and easy to deploy using the Global Delivery Model. It is based on industry standard process quality frameworks (CMMi, CMM, etc.) and uses rigorous methodologies and the expertise to mitigate risk and deliver cost and time-to-market benefits.

We use a software development process that is fully documented and constantly improved. It is based on best practices and industry standards like Agile-Scrum, Iterative-Incremental Model, Rational Unified Process, and Oracle PJM. We follow CMMI as process model and maintain all project development in tandem with standard defined by CMMI v1.2 maturity level 3. This process enables us to successfully develop projects within your budget and time frames and, of course, with world-class quality

Application Development

We give top priority to the software implementation phase the success of software relies on feedback and corrections. Solution is released in three stages as alpha, beta and stable based depending on the contract. Our Marketing and Support division have specialized people to provide user training and support.

UVJ’s Offshore development model is very successful and proven in life science projects. Customers have full control over the project and the human resources; and the project results can be provided to the customers and can be controlled on regular basis. Onsite / Offshore Training and Feedbacks are done periodically to ensure the direction development services.

Application Maintenance and Support

UVJ's application maintenance services help you get the best out of your existing IT applications. The services span offshore-ability analysis, maintainability analysis, maintenance and enhancement and are delivered using the Global Delivery Model. We use structured knowledge management tools and other IP developed by our Maintenance Center of Excellence to enhance the life of your systems, ensure that they evolve with your business, reduce system downtime and help you focus on strategic initiatives by minimizing the time spent on routine activities.

Application Maintenance

Application Support Services

UVJ's offers support services for applications, middleware platforms and technologies.

  • Application Operations

Includes 24x7 monitoring of applications for availability/performance/capacity, batch monitoring/management. Application service desk includes incident management activities such as incident recording, initial investigation of issues, tracking and escalation management and closure, user administration and service reporting

  • Production Support

Involves a detailed analysis of incident, incident resolution and problem management activities such as trend analysis, root cause analysis, known error establishment, creation of RFC and break fixes excluding code changes

  • Release and Change Support

Comprises setting up of various test environments, release/change activities such as release coordination, emergency releases, build and code deployment, managing release calendar and configuration management/SCM tool administration

  • Middleware Product Support

Includes product administration activities such as monitoring, user administration, application deployment, patch management and configuration management for application infrastructure: Web servers/application servers, messaging infrastructure, content management and DW/BI tools

Application Development services helps
  • Address evolving business
  • Technology challenges by defining
  • Designing and building applications

Offshore Software Services

UVJ’s Offshore development model is very successful and proven, especially in life science projects. Customers have full control over the project and the human resources; and the project results can be provided to the customers and can be controlled on regular basis [according to the project plan]. Project can be managed by customers or by the Manager from UVJ Technologies. Onsite / Offshore Training and Feedbacks are done periodically to ensure the direction development services.

The onsite team communicates with our offshore development and are able to set the deliverables based on the priority. Onsite team is able to provide solutions critical issues, while offshore team will work based on scheduled way. This effective way makes it 100% utilization of work resources and on-time delivery.

Offshore Development

The project management can be either on UVJ's or Customer's side. In both cases sponsor/relevant stake holders have full control over the software lifecycle. We provides environment for such cooperative software development that supports informal communication as well as planning, defining, manipulating and supervising cooperative development activities.

Laboratory Automation

Laboratory Automation Services

UVJ have expertise in enabling new/advanced technologies in labs for automating the life science and clinical operations by the means of our software solutions. We have experience in providing life science solutions in a collaborative model and are proven to be very successful with out Global Partners.

Lab automation includes the coordination of different scientific instrument with the help of robotic equipments. We have expertise in enabling automation solutions for chromatography, automated assaying, liquid handling, combinatorial chemistry, robotics etc collaboratively with our partners.

If you are looking for an IT partner who can offer software services for automating your lab operations, we can provide you the best services and products that will make your lab operations simple and fast.

When it's time to reducing costs, and improves productivity, it's time for automation. We offer lab automation that fits your lab and thus you can

  • Simplify the operations
  • Integrate , Manage and Serialize the operations
  • Instructs & Schedule operations
  • Manage inputs & Outputs
  • Visualize Operations and Results
  • Analyze the Results statistically
Lab Automation

We have specialized team for analyzing the requirements and automation will be defined by the help of experts in science and engineering. Scientists and Engineers make great efforts to combine automated devices with mathematical and organizational tools to create complex systems for a rapidly expanding range of applications and human activities. Labs Instruments can be Dispensers, Incubators, Robots, Scanners, Liquid handlers, automated assaying machines.

The main features UVJ can implement:
  • Administration module
  • User management module
  • Central Location
  • Audit trails
  • Electronic signatures
  • Reports

21-CFR-Part II Compliant Software

The FDA (Food and Drug Administration) released 21 CFR (Code of Federal Regulations) Part 11 in 1997. It made electronic records and signatures as valid as paper records and handwritten signatures. It allows the use of electronic record-keeping systems in compliance with regulations. Part 11, known as "Electronic Records; Electronic Signatures", works in tandem with other FDA regulations that require organizations in the biomedical field to maintain records.


What we can implement?
From the programming standpoint, UVJ implements Technical Controls while we ensure that our client organization has complete Administrative and Procedural Controls.

The main features UVJ can implement are

  • Administration module
  • Audit trails
  • User management module
  • Electronic signatures
  • Central Location
  • Reports

Experience of UVJ with CFR

UVJ has dealt with CFR compliance projects for different clients. We have designed and implemented the Technical Controls features to address the CFR Part 11 requirements.

We can implement the following features to address different aspects of the CFR requirement:

CFR Implementation details

To ensure Part 11 requirements are met, three types of control must be implemented:

  • Administrative Controls
Set policies, assign responsibilities, training, notification, auditing, etc.
  • Procedural Controls
SOPs, validation, calibration, installation qualification, etc.
  • Technical Controls
Computerized features to assist/enforce administrative/procedural controls

Administration and user management

  • Each user has a login name and password upon first entering the system. All user ID's and passwords are encrypted for security.
  • After logging in, the user can lock the application to prevent unauthorized access to it. Only the logged-in user can unlock the application.
  • The system administrator defines permissions for each user to access different features in the system.
  • Only the system administrator has the privilege to create and edit user accounts and assign access rights to users.
  • Administrator can define a set of global policies that is applicable for all users in the system. For example, the number of failed login attempts is a policy. Administrator can set the value of this policy.

Central Location

  • Files are stored in a Central Location on the local PC. Only the application has access to files within this Central Location. User can modify and save files only after user's privilege has been validated by the application.
  • Application lists all files and folders in Central Location.
  • Application provides a backup mechanism of files in Central Location.

Validate the system

  • We can implement validation services including IQ (installation qualification) and OQ (operational qualification) to ensure that the system is fully compliant. Files are locked inside Central Location, which prevents data tampering.

Electronic Signature

  • All records signed electronically capture the username, time/date and meaning of signature. Additional information can also be included at set-up, such as designation.
  • The signature information cannot be tampered with after approval.
  • User can revoke the signature.

File history

  • Keeping the history of files - User can view the history of all the revisions and signatures.

Audit trail

  • All actions made are captured in the audit trail. This includes software installations, upgrades, administrator and user actions, application and instrument related operations, electronic signing, files modifications in central data repository, etc.
  • Providing different search methods to display the audit trail records.
  • User can export the audit trail to files in different formats like XML, excel, text, etc. for further examination.

Reports

  • Reports - User can preview and print administration, user management, validation, and audit trail records
UVJ's ways to ensure authenticity and confidentiality

According to the Part 11 section 11 the software need to ensure authenticity, integrity, and appropriate confidentiality of electronic records. For this we have implemented different features like:

  • System administrator can define permissions for each user to access different features in the system.
  • Administrators have all permissions and may restrict user access data files as necessary.
  • All actions made on any data file are captured in the audit trail.

UVJ's methods to minimize the invalid users and reject invalid operations include:

  • Implementation of the user authentication methods like login, automatic and manual locks, electronic signature, etc.
  • Encryptions of all the passwords in the database
  • Implementation of different password management policies like maximum failed login attempts, password expiration, other policies like minimum password length, use of different characters, etc.

To ensure accuracy, reliability and consistent performance of software we have implemented different validation methods like installation qualifications, operational qualifications, etc. We have also created a Central Location to store the files created by the application. Only the application can access the files and thus it prevents file from getting tampered. All records signed electronically capture the username, time/date, meaning of signature etc. User can view the file history and the changes made to each version of the file. Also, all the operations in the system are captured in Audit trail table. User can preview and print the reports and export to different formats like excel, xml or text for later use.