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Oasis QMS, An Integrated Quality Management Platform

Oasis QMS, that works for your business ...

In regulated environment specifically for pharma manufacturing company, products that are manufactured on the basis of good manufacturing practice (GMP) guidelines bear no risk to the consumer and considered to be of good quality. To produce such a quality product, companies are required to build a robust quality management system, integrated risk management to ensure compliance with GMP standards set forth by many FDA and regulatory agencies.

Oasis QMS helps make informed compliance decisions, accelerate delivery of new products, achieve and prove regulatory compliance across the enterprise, avoid costly system duplication and ongoing validation costs, ensure consistency of information and processes, quickly respond to new regulations and legislative demands without having to rethink the entire approach 21 CFR Part 11 compliance for electronic signatures and audit trails. Workflow based electronic forms for automation and processing of regulatory events such as Change, Deviations and CAPAs offers full traceability and accountability-including who viewed, reviewed and approved documents, key decision points and sign-off on compliance processes.

Oasis quality management system (QMS) consists of configurable, easy-to-use and connected applications for automating, streamlining and effectively managing change controls, deviation, incidents, complaints, CAPA and Pharma based quality processes on a web-based or client/server based platform that enables you to be compliant with internal and external regulations.

QMS, Integrated Modules

  • Change Control Management

  • Deviation Management

  • Nonconformance Management

  • CAPA Management

  • Audits Management

  • Product Quality Review

Features ...

  • Security and Audit Trail

  • Electronic Signature

  • Dashboards, Reports and Analytics

Change Control Management (CCM)

A comprehensive module that enables organization to effectively manage changes to processes, documents (STPs / SOPs / Procedures), facilities, hardware, software, engineering, products, equipments, protocols and other areas.

As the new regulation emerges and existing regulations become more stringent, the effort to minimize the loss of quality and managing ongoing changes is very challenging.

Having to keep track of all different types of changes to SOPs, work instructions, design specs, training plans, procedures, formulation etc., without a change management solution is ever growing headache of all companies, big or small.

The module comprises of initiation of change from department, assessment and recommendation by head of department, QA-QMS group review/selection of team, forward for impact assessment by associated departments, evaluation for acceptance/rejection of change, change implementation planning and execution and finally closure of summary.

Basic Workflow ...

Oasis Change Management system is integrated with other solutions to create a closed loop Quality Management System. Oasis powerful analytics and reporting capability helps to perform trend analysis and spot recurring problems quickly and easily. The interactive executive dashboards of Oasis change management software provide meaningful change statistics to management to make informed decisions to drive continuous quality improvement and meet regulatory compliance needs.

Deviation Management (DM)

Oasis deviation management tool helps capture defects and assess their risk. OasisLIMS simple deviation reporting option lets you quickly capture details like part, quantity, failure type, and severity.

With this module, you initiate and document planned and unplanned deviation with supporting documentation, define root-cause of deviation, evaluate and investigate to analyze risk at any point in the process with initial and final risk assessment, resolve problems quickly, keep every department in a loop and optionally integrate and escalate with CAPA Management to manage high risk.

In a simple term, a deviation means that a problem has occurred and it needs to be addressed. It happens when something does not meet the specification or requirements in some way.

Deviation management solution complements your established nonconformance process and enables your organization by helping to identify the problem, document, evaluate/review, and investigate on need of further corrective actions

Basic Workflow ...

Oasis deviation management software has powerful analytics and reporting capability that provides you a real-time visibility of critical information of the deviations to help you make an informed quality decision.

Non-Compliances Management (OOS / OOT)
Adherence to the specifications and testing for conformity to the written specifications is required for every component of the product such as pharmaceutical ingredients (API), excipients and other components, in-process materials, and finished products/stability samples, if that fails there's an (OOS) out-of-specification test result, an investigation must be conducted and its results documented.

OasisLIMS-QMS offers the flexibility, functionality to record case of OOS and configurable (user defined) investigations checklists with advanced tracking functions. This module helps users capture data on forms automatically from LIMS. The system offers best-practice features to incorporate all the steps and procedures from initiation to summary/conclusion of OOS incident.

The out of trend (OOT) are those suspected results or sequence of results that are within specifications but are unexpected based on historic information such as Assay, RS, Disso., water/LOD etc. Similar to OOS module, there is a separate comprehensive procedure to handle record and investigate out of trend (OOT) results for campus including stability samples.

Corrective and Preventive Action (CAPA)

CAPA Management helps companies develop a risk-based, streamlined problem resolution process. Oasis-QMS has effective CAPA handling module in the system that improves product quality and safety, increases customer satisfaction and more importantly ensures compliances with the standards such as those set by FDA/ISO or other regulatory authorities.

CAPA, is a systematic investigation of the root causes of identified defects/problems or identified risks to prevent their recurrence (corrective action) or to prevent the occurrence (preventive action).

The advanced capability of CAPA management software complements established CAPA process and enables your organization to take a holistic approach to document, plan, investigate, perform root cause analysis, perform risk assessment, implement, perform verification and effectiveness steps, resolution of quality issues. The standard Workflow of CAPA: Initiation / corrective and preventive action plan and execution (major tasks, resources required and deliverable timeline) / implementation verification / effectiveness check / CAPA Closure / CAPA extension approval / CAPA extension (optional) / CAPA logs / CAPA reports.

CAPA Management's reporting capabilities give the tools to identify regulatory threats and areas for improvement, includes departments; Quality assurance/control, Manufacturing, Raw / packing / finished stores, Maintenance, Supply chain, Regulatory affairs, Formulation / analytical research developments, Information technology, Engineering etc.

Basic Workflow ...

CAPA Sources:
Connected with Deviation management, Market complaints management, OOS results, OOT results, change controls, lab / environment incidents, Equipment calibration / validation failure, Batch failure, Product recall, Stability failure, PQR, Audits etc. The essential part of the CAPA process is to get an early signal of quality issues from your subsystems. Oasis CAPA management software has inbuilt powerful analytics and reporting capability to provide you an early indication of quality issues so that your organization can take simple corrections.

Auditing Management (AM)

In present scenario regulatory requirements are becoming more stringent, and the cost of compliance is growing. At the same time, audit management is becoming increasingly challenging, given the number and types of audits that need to be conducted.

Oasis Audit Management complements your established audit management process and empowers you to improve quality, reduce costs and identify operational and compliance risks by effectively managing the full audit lifecycle by, creating an audit plan, scheduling an audit, preparing an Audit, executing audit, track findings, performing Follow-up and closure. Oasis audit management software solution is flexible and highly configurable, making it very nimble and adaptive to various types of audits such as internal, external, regulatory, vendor etc.

Basic Workflow ...

Oasis audit management software system has powerful analytics and reporting capability for compiling audit reports, easy status tracking, analyses auditor performance and audit results. The interactive executive dashboards provide meaningful audit statistics to management to make informed decisions.

Product Quality Review (PQR)

The regulations require an annual product quality review (PQR) of all products that are manufactured at a manufacturing facility. OasisLIMS-APQR module helps you meet objective of verifying the consistency of the existing manufacturing process, the appropriateness of current specifications for raw materials and finished products and the ability of your stability data to highlight any trends, and to identify product and process improvements.

The analytical data is captured from OasisLIMS for all the stages the product goes through including in-process and finished stage with batch tracking. Annual product quality review for all the batches of a finished product manufactured during the year / period:

Decreases the risk of OOS results / minimizes the risk of rework-reprocessing/ decreases downtime

Increases productivity / decreases the risk of product recalls / meets all regulatory commitments / requirements

Improves communication between production, engineering, quality and regulatory functions; recording of process / raw data on various stages

Graphical representation / histograms of processing parameters / generation of trend on yield data

Generation of reports from OasisLIMS on various quality attributes of finished product / storage, maintenance of stability studies records / data trending of selected tests, graphical representation of analytical data and summaries, provision to maintain complaints data, product recall data / deviations, Failures and OOS results handling / change controls, etc.

Integrated LIMS Training Records Management Module for Labs

OasisLIMS integrated training records module permits your lab to keep detailed training records for all of your analysts and chemists, on the basis of training sessions attended on test procedures, operating procedures etc. your technical staff members are granted qualifications in a manner that is consistent with record keeping requirements for GLP and ISO 9000; Accordingly, analysts are granted the ability to enter results for only those testing procedures for which they have been trained.

With this module you can track user certification to execute test procedures.

Training Management System

Suitable for large laboratories and manufacturing environments

Oasis Training Management System enables you to keep records of internal and external training activities for all personnel in an organization. As per the norms, all executives should be granted qualifications on the basis of training courses attended/qualified. Training program may be focused on any product, process, instrument or test procedures.

It generates comprehensive Reports and Analytics quickly. It maintains all the training records to assure full compliance with CFR Part 11, with audit Trails and ER / ES also.

Major functions of system Includes ...
Setup employees/trainees/trainer masters, register the personnel involved the training programs organized; Subject groups, records of different subject groups and under it subject masters defined with descriptions;

Question Bank, record of the questions of different type i.e. objective, subjective, true-false or matching type, applicable to the specific subject managed in the system.

Seperate provision for induction training for new employees including circular, receipt and training, feedback report, induction training evaluation / qualifications;

Yearly / Monthly Planner, work around an annual / montly plan of training session on various subjects by different departments to effectivly organize trainings.

Training Session, scheduled / unscheduled training session can be conducted for a specified subject by departments; Training Conduction, training conduction is grouped into two categories, session based or self-based. Training Assessment, under manual mode an assessment reporyt can be prepared by the trainer to evaluate the performance of trainees and fix the marks and grades for certification.

Online Examination can be scheduled after completion of training, it includs Session Number, Question Bank Number and the Subject; relavent questions are filled up automatically based on the criteria, trainees give the answers of questions shown online one after the other till the end;

Examination Training Evaluation, System performs evaluation of on-line examination automatically for fixing marks and grades to evaluate the performance of the trainees;

Training References, provision for linking of SOP / reference documents to support training on different subjects is available.

Reports section provides the facility to generate reports and print ... Employee, subject master, question bank, induction training circular, feedback, final report, yearly, monthly calendar, detailed training card / logs, training schedules, held, completed, attendance sheet, assessment sheet,trainee grades and certificate etc.

Complaints Management

A comprehensive complaints managcement process is available in the system to handle different types of complaints received from market regarding product quality. Provision is available for routing and escalation management of complaint by assigning tasks to an individual for further investigation, conclusion and corrective action with final closure. Various reports are available to track users and their actions involved in the complaint processing.

Registration of complaint for a product with respect to type, batch details and location and attachment of related documents.Receipt confirmation of complaints, initiation of primary investigation and formation of team from various depratments. On-line references to lot data, retained in LIMS database, fixing suspected / counterfeit, root-cause analysis, investigation conclusion, CAPA initiation and action, implement changes/training etc.

CAPA verification, feedback from sources/regulatory, complaints closure.

A set of reports can be generated such as Intimation sheet, complaint form, investigation analysis and reports, complaints log book/status, closure report etc.