|
OasisLIMS
has various plug-in and Use add-on modules to cover various
quality assurance activities.
Stability
scheduling, Reference standards management, Quality cost analysis,
Control sample management, Market complaints records and analysis,
Vendor rating, Trend analysis, Equipment calibration, Training,
Renewal of licences, Trade returns analysis, Production problems
and analysis, Inventory of chemicals / working standards,
Dissolution profiling.
Stability
scheduling and data compilation of finished products
Selection of products for stability, Stability scheduling at
various experimental conditions, Stability schedule printing,
Stability analysis and printing of protocol / data, Graphical
representation
Control
samples management
Maintenance of control samples with their quantity, packing,
location and relevant batch details, Generation of control sample
register, products for retest as per in-house requirements,
products for destruction based on the expiry date and as per the
FDA requirements
Market
complaints records and analysis
(for effective handling
of market complaints and recalls) Market complaints entry,
Market complaints corrective action, Market complaints register,
Pending market complaints, Market complaints analysis and review
Equipments calibration records
For
establishing performance characteristics of various equipments,
Equipments calibration - test links including specific directions,
schedules, limits for accuracy and precision, Annual maintenance
contracts, Periodic calibration register, Calibration reports for
corrective calibration action
Trade
returns analysis Trade returns register, Trade
returns analysis - dealer wise / product wise, Generation of
expired products list
Training
records Training documents on new recruits and
existing staff, Training summary for various departments,
Effective periodical assessment of continuing training and its
practical effectiveness
Renewal
of licenses
Complete relevant information
about various licenses required as per Drugs and Cosmetics Act and
the Rules made there under, Licenses register incorporating
salient pre-requisites, Renewal status reports
Reference
/ Working standard management
Effective maintenance of
Reference standards / Working standards on the basis of
procurement details, source, assay, standardization, usage etc.
Vendor analysis
Vendor rating product wise / vendor wise and subsequent
inclusion in the approved vendors list
Trend
analysis of finished products and raw materials
Generation
of Trend analysis for user-defined critical parameters, Graphical
representation of trend analysis
Download Demo |