Software Solutions

OasisLIMS

Laboratory Information Management System (LIMS) read more

LIMZ-RD

For R&D centers / labs, for automation of R&D activities in pharma research specially in FD division and ADLread more

EnviroLIMS EWM

LIMS for environment labs, water quality monitoringread more

True-LIMZ CTL

LIMS for commercial testing labs (with integrated billing)read more

Stabi-M

True web based enterprise software for stability studies data management and compliance with US FDA 21 CFR Part 11read more

Olink

Equipment connectivity, to efficiently transfer analytical data from instruments to OasisLIMS read more

CrisCon ERP

Pharma ERP - Enterprise version: Specially designed to automate various activities of manufacturing unitsread more

CrisCon SFA

Sales force automation, web basedread more

Oasis CMS

Change management and control systemread more

O-Doc eBR

Electronic batch records maintenance software with electronic instructionsread more

Oasis APQR

Annual product quality review and records of batches producedread more

Optional Modules with LIMS - Part BLims > Software Solutions > 


Optional Modules with LIMS - Part B OasisLIMS may be integrated with following “plug-in and use” add-on modules to cover various quality assurance activities:
  • Change Control Management (CMS)
  • Deviation Management / OOS / OOT
  • Product Quality Review (PQR)
  • Corrective and Preventive Action (CAPA)

Change Control Management (CMS)


Image 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. The module comprises of initiation of change, impact assessment, evaluation, change implementation and closure.

Deviation Management / OOS / OOT

OasisLIMS 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, 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, integrate and escalate with CAPA Management to manage high risk.

Product Quality Review (PQR)


Image The regulations require an annual product quality review (PQR) of all products that are manufactured at a manufacturing facility. OasisLIMS-PQR 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 out-of-specification 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 of processing parameters
  • Generation of trend on yield
  • Generation of reports from LIMS on various quality attributes of finished product
  • Storage, maintenance and generation of exhaustive reports on stability studies at different
  • experimental conditions, time points and packaging conditions
  • Data trending of selected tests and graphical representation of analytical data
  • Provision to record and maintain summary and discussion of quality attributes
  • Provision to maintain market complaints data, product recall data
  • Deviations and OOS results handling
  • Change control and failures

Corrective and Preventive Action (CAPA)


CAPA Management helps pharma companies develop a risk-based, streamlined problem resolution process. CAPA Management user-friendly tool includes: Initiate CAPA process, Record investigations and complete by documenting your investigation methods, action plans and approvals. CAPA Management’s investigation process also lets you map actions to their root causes to eliminate defects at their source, ensure CAPA effectiveness. CAPA Management’s reporting capabilities give the tools to identify regulatory threats and areas for improvement. It includes: Departments
Quality assurance, Quality control, Manufacturing, Raw / Packing materials store, Central packing, Human resource, Maintenance, Supply chain, Regulatory affairs, Formulation development, Finished goods store, Analytical Research Laboratory, Contract manufacturing, Information technology etc.


Image CAPA Sources
Deviation management, Market complaints management, Internal audit observations, External audit information, PQR, OOS results, OOT results, Trend analysis report, Environmental monitoring, Equipment calibration / validation failure, Batch failure, Product recall, Stability failure, Change control etc.
  • CAPA Initiation
  • Corrective and Preventive action plan (major tasks, resources required, deliverable timeline)
  • Verification / Effectiveness check
  • CAPA Closure
  • CAPA extension
  • CAPA extension approval
  • Documentation
  • CAPA Report
  • CAPA Tracking log