lisa.lims
is ISO17025 Compliant
lisa.lims is a effective quality management
system that has the technical competence
to track and monitor your laboratory in all
area vital to ISO 17025 accreditation such
as:
ISO 17025 is a quality standard for testing
and calibration laboratories. It covers both
management and technical requirements. Management
requirements describe the operation and effectiveness
of the quality management practices with
laboratory. Technical requirements address
the capability and capacity of staff, methods,
equipment, calibration and reporting.
PersonnelLaboratory personal must
be allocated the access to a specific scope
of work based upon documented qualifications.
Only competent personnel can perform testing
services. The laboratory must demonstrate
accountability for the work performed by
its employees. Employees performing specific
tasks shall be qualified on the basis of
appropriate education, training, experience,
and demonstrated skills, as required by the
scope of testing. Personal duties have to
be clearly defined and all work needs to
be traceable to the analyst.
lisa.lims Benefits
- Qualification
tracking allows management to track
the education statues their employees.
- Audit
trail reports capture the story of
every sample
- Capture
the entire audit trail with unique
log ins and role based security
- Configurable
release and sample workflow with
no programming
|
Test
and Calibration Methods
Only validated and current methods are used
to obtained results. Quality Control standards
are set forth for selection and validation
of standard methods, statistical analysis,
and control of data. Accurate test and calibration
results can only be obtained with appropriate
methods that are validated for the intended
use.
lisa.lims
Benefits
- Ensure
correct method selection by creating standardized
test plans
- Track
validation experiments separately from
customer samples
- Document
changes to sample data and deviations
from methods
- Notifies
laboratory staff on samples being performed
with out of date procedures.
- Auto
calculate measurement of uncertainty
is applied to data and checked for limit
violation
- Import
and calculate data in a validated environment
Equipment
Maintenance and Calibration
The
laboratory has to insure that the instruments
are suitable to perform selected tests
and are well characterized, calibrated
and maintained. All laboratory equipment
is to be maintained in good functioning
statues in accordance to documented specification
requirements. Equipment maintenance and
quality control testing needs to be performed
and documented on a regular basis.
lisa.lims
Benefits
- Track all
maintenance and calibration records
- Automatically
generated unique QC, Blank, & Spike
samples
- Bidirectional
instrument interface makes sure that all
data is capture in a validated environment
- Clearly document
all sample transportation, handling, and
storage information
- Identifies
if out of date methods where used for calibration
and maintenance
Document
Control and Reporting of Results
The
laboratory shall establish and maintain
procedures to control all documents that
form part of its quality system. An Approval
and review process for controlled documents
has to be in a place accompanied by any
revision and distribution statues. All
Documents must be legible and easily retrievable.
Reporting of results section has some general
requirements on report formatting such
as clarity and accuracy but it also has
very detailed requirements on the contents.
Email us your report for a free ISO compliant
evaluation.
lisa.lims
Benefits
- Designate
workflows for document approval, activation,
and revision based on user access rights
- Assign
document to methods and track access history
- Store
all documents in a controlled environment
- ISO
compliant report design by expert consultants
lisa.lims
Document Management Module:http://sigmaplot.com/products/lisa/modules.php#dms
Control
of Data
Calculations and data
transfers shall be subject to appropriate
checks in a systematic manner. Certified
and documented developed software and calculation
have to be in place when computers or automated
equipment are used for the acquisition, processing,
recording, reporting, storage or retrieval
of test.
lisa.lims
Benefits
- ISO 9001 certified system
- Allows
for separation of ISO and non-ISO accredited
methods
- Data
is protected in backed up in a industry
leading database, Oracle.
- Imbedded
data backup and recovery procedures
- Quality
assured data transfer systems.
|