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OasisLIMS has been in use at many pharmaceutical organizations from many years and has evolved as a matured product with common pharmaceutical functional requirements specifications in place, that broadly covers pharmaceutical specific workflows, such as sample management and batch release, stability testing, instruments, standards and reagents management, and barcode enabled label printing. Accordingly the system delivered with minimal configuration changes as a standard product and masters preloaded to quickly start the project. Also, our team of experts understands the complex requirements of pharma quality control laboratory, with experience and knowledge acquired during implementation ensures 100% success in smooth deployment of system. Practically, the major activity of implementation is focused on end user training and assisting them in executing validation of system on the basis of pre-designed validation script from User Requirements, IQ/OQ/PQ, to Go-Live Release stage.
Typically, implement of project takes about 3 – 4 months from installation to go-live with OasisLIMS where as traditionally it used to take about 12 – 14 months time. This is due to the proven and established implementation processes and configurable user defined templates / reports clients are up and running fast.
The IQ, OQ/PQ protocols are designed and targeted at system functional delivery, all the standard verifications and controls are included in the protocols format, test scripts/cases are fully documented for each process incorporated and accordingly referenced to the standard operating procedures i.e. User Manual/SOP.
Documents shipped under validation plan are IQ/OQ/PQ, User Manual / SOP.
Software continues to improve even after it is purchased, installed and implemented in your lab. Oasis warranty covers the software for a certain period of months after the installation of the basic software.
To ensure that your laboratory continues to take advantage of functional advancement in LIMS, Windows and Client/Server technologies, we strongly recommend the purchase of the Oasis - Support and Update Services. Coverage entitles the user to technical support via telephone and software updates as they become available.
Software is only useful if it is used, and used properly. Multiple options are offered by Oasis for training both the LIMS administrator and the end users of the software. Oasis training is both formal and informal, so it fits the style of your organization. Oasis offers training courses on and off premise on demand basis for any and all users under very controlled conditions. Our experience has been that generic classroom training for LIMS is of limited use, training designed by Oasis includes practical and hands on sessions to reduce the learning curve and grasp the workflow in a short period of time.
Before the Oasis design & implementation process begins, a system administrator and backup must be designated. These staff members must have an intimate knowledge of the laboratory and be authorized to make critical decisions which will influence the design of Oasis. We strongly recommend that all staff members who will be influential in the design of special OasisLIMS functions take the time to learn the basic design and user interface concepts of OasisLIMS by executing the Tutorial which is delivered with the Core software. Remember, this is a mission critical application that you must rely on for many years.
A few days of familiarization is an excellent investment of time which will allow you to effectively communicate your requirements to OASIS during the configuration and implementation process an efficient manner. This will ensure a faster implementation and result in far fewer "surprises" than if left to the discretion of your Oasis design team. The Oasis implementation process occurs in a logical and well-organized manner. The process requires effort and commitment by both the OASIS and Customer staff.
All Oasis network system products incorporate functions as per regulatory guidelines and computerized validation functions required by GXP. Oasis provides full documentation including IQ/OQ, Certificate of compliance, and inspection test result reports based on certified system. Oasis total solution for Pic/s, GMP, FDA 21 CFR Part 11 and computerized validation – establishes proof for reliability and security built in the system. Systematic validation support for creating system operation and management procedures required for FDA compliance by providing ready to use DQ / OQ / OQ computer validation templates.
Oasis offers validation and documentation assistance to customers on the basis system configuration in accordance preparation of documents in such a way that relevant and applicable parameters of V-model life cycle are followed appropriately as a standard.
Project plan including training plan / training logs, System concept including risk analysis, Hardware design / requirement specifications
User requirement specification, Functional specifications, Traceability matrix (against URS, FS)
Software installation acceptance testing including network qualification Traceability matrix (against IQ)
Manuals / SOP’s
System / user acceptance testing
Test protocol results
Problem resolution forms
Operational / performance qualification report
Traceability matrix (against OQ/PQ)
Validation report and summary, Certificates
From Enterprise Resource Planning to Invoicing, third-party software integration allows you to operate seamlessly with OasisLIMS. The list includets … SAP B1/ECC, Navision, Tally and many more … It is common for uni or bi-directional communication where OasisLIMS not only accepts data from other systems but sends data as well optionally, data can be transferred between the two systems or one way from either system.
Oasis has separate team for design / development and implementation of Integration with SAP at various levels of allocation interface on standard touch points. Our integration development environment is completely flexible to manage the most challenging manufacturing and laboratory processes.
Oasis created and deployed a LIMS-SAP interface that utilized the SAP QM module to create lots, upload quality data and usage decisions, and synchronize lot information between multiple LIMS instances and a single SAP instance.
OasisLIMS, has received the “Powered By SAP NetWeaver®” certification status from SAP labs Bangalore based upon successful integration testing with Integration of SAP-QM module that is part of the SAP ECC 6.0 / 7.0 product suite. OasisLIMS has an interface to the SAP Quality Module using the BAPI and Text/CSV based batched integration modes. Oasis also has SOA / XML based high level of integration robust bi-directional communications link that ensures transfer of data from one system to the other without any miss for achieve data integrity. The interface is based on standard or customer independent parameters and touch points an fully custom designed integration between the both the systems. OasisLIMS tracks manufactured lots of material that may require testing during manufacturing / receipt of external lots and for approvals and release. OasisLIMS sample login process has been specifically interfaced and configured with SAP-QM module which drives the creation of new Lots to OasisLIMS environment. Once the analysis is complete, the result of each test parameter and sample status with other key information is passed back to SAP "Usage Decision" for updates.
Creativity, talent, and expertise allow Oasis software developers to suggest ways in which you can transform your business. Oasis has high skills in a wide range of n-tier development tools and methodologies on various technologies including, Visual Basic, Microsoft .NET, database services and administration – all popular RDBMs; testing, validation and facility management. Oasis is well versed in web and software development using latest software development tools and technology. Oasis Benefits:
Cost effective solutions
Strong domain knowledge
Technical expertise
Oasis has an experience of many years in pharma business in the field of software development working on various technologies ASP.NET, VB, SQL/ORA, the company has a strong team of 25 developers including many software professionals and pharma domain specialists.
Open for exploring possibilities in off-shore outsourcing business in software development services on all latest technological platforms, consider outsourcing to India their best option since it is one of the largest talent pool of engineers and computer professionals in the world.
We are open for re-sizing the team if volumes increase in future. Jaipur, in rajasthan state, 200n miles from Delhi capital, has become northern India's preferred educational center and upcoming IT destination, there are 32 engineering colleges having computer science/IT in their curriculum, and we can utilize the potential in our favour and at the same time the newcomers can get excellent