Though there are many views about the ideal features that must be in LIMS, we have taken a representative sample from various sources to summarise the SCC LIMS position on these. LIMS Book and Buyer guide is one of the primary reference while others are feedback received from various industry stakeholders through various workshops and demo sessions with them.

Features Sought in LIMS

SCC LIMS Features

Audit and Access Control

Audit Trail: Actions of Engineer, approver, certificate publishing (whether these are captured in the audit)	Limited to last modifier, last reviewer, certificate generatorBasic supported, Extensive audit module is in progress
LIMS should provide accesses to data and modules based on current Role.	Fully compliant
Multi level of hierarchies required to support workflow and ISO:17025 requirement	Two levels hierarchy ie Calibration Engineer and Approver in addition to contributor
User based access definitions: Does the application allow user based accesses to override role based accesses (in some cases where resources are on development plan, their role may be same but their responsibilities may get increased)	Fully compliant, roles could be grouped and exception can be made in user accesses by the administrator
Can labs define user and role based accesses by themselves or they would need to make request.	Fully compliant, Labs need to nominate a user to whom these administrator privileges can be granted who then can manage users,roles and accesses.
Are the accesses granted at application level or at Job Level, as ISO17025 expect authorised signatory and engineer to be kept separate role (no access to customer name except in onsite calibration) while sales team should not have access to calibration data	Calibration/Testing specific roles can be defined at the time of project and Job card assignment by the project administrator. User can be restricted to view only his Job or Project details as well.However for other CRM modules, accesses are to be defined at application level.

LIMS Configurability

Configure Users, their accesses, passwords, Job profiles, departments, contacts or application look and feel.	Fully Compliant, SCC LIMS is completely modular and modules can be enabled or disabled as part of configuration depending on customer requirements
Designing new data sheets for capturing observations.	Fully compliant
Designing new reporting template (certificate)	Reports in PDF or ODT formats
Defining new attributes/parameters for the instruments	Fully compliant, business administrator have privileges to define new attributes relating to instruments
LIMS should not impose what to be printed on the report or certificate, it should be lab prerogative to design their report format with as much or as less details that are appropriate.	Fully Compliant, SCC LIMS provide this feature with ODT based certificates, labs can decide which field from super-set of data available to be printed on the certificate, For PDF templates, user can specify attribute to be printed in test result section

Data quality, process and regulation compliance

LIMS should provide feature to validate the input data (that could be in range, min or max).	Fully compliant
Manual result entry	Fully compliant
LIMS should provide flexibility to lab to define their validation criteria using the formulas in their data capturing sheet	Fully compliant, labs can define their own formats with validations and formulas to support the user and keep data accuracy
LIMS should be able to prevent common lapses (and hence NC) on account of Instrument or User expired certificate date.	Fully compliant, SCC LIMS validation on Standard meter certification expiry date restrict user from using standard meters to be used for data capturing stage itself.
Multiple stages of Review /Approval cycles with the provision of resetting the process to start from the beginning	Limited compliance (only second level approval),Single stage of review/approval is built in the SCC LIMS. However this cycle can be repeated number of times with the approver having permissions to disapprove earlier approval and resetting of the experiment
Document Management with the versions	Fully compliant, SCC LIMS is now generating automatic version and keeping old version of final report
Automatic electronic signature affixing on certificates and calibration reports	Fully compliant, SCC LIMS allows signature of engineer/Authorised signatory to be printed if required by the labs on calibration certificate/test report

Data management and reporting

LIMS should support the entering of all types of result, one is likely to see i.e. numeric, alphabetic, symbols/operators or photographic (screen shots).	User can upload images, and screens shots with the test results, option of publishing these images as appendix in test report
Automated data backup	SCC takes backup of hosted database of LIMS and CRM applications on daily, weekly and monthly basis
Menus and options of the application should be self -understood, even better if facility is there to rename if required to align with nomenclature prevalent in the Lab	Fully Compliant, user navigation is easy and clear as all options are on the same page. Options can be renamed if required by the user without changing the source code
LIMS should be able to extract data for exporting to other applications in use by Lab (such as for invoicing, financial accounting)Compliant,	SCC LIMS allow key data related to customer, contacts, invoice etc to be exported in CSV and Excel format. Customisation may be required to export in different format
Import data Interfaces to other applications	SCC LIMS can import customer,product data through CSV formatted files
Easy to understand MIS and reports to help management in accessing performance, progress and efficiency.	Report module in the SCC LIMS provide ready made reports for the consumption. In addition to these, new reports can be requested from SCC report designers.
It should have features to send application generated documents (Word or PDF or report in CSV formats) by email.	All the documents generated using the applications can be sent through application mail. Additional external documents can also be attached to the emails.

Managing customer and business: added value features

Schedule event of task assignment on calendar of the users.	Application schedule task in case of prospect assignment to sales representative, job assignment to engineer
Automatic mail reminding customers about pending calibration of instruments	SCC Calibration LIMS trigger mail to sales representatives providing list of all instruments of calibration that are due for re-calibration in pre-scheduled number of days
Email notifications relating to task assigned could be sent to the user.	Fully Compliant, a standard worded mail is sent to the assigned user informing about the task assigned
Project Management.	Fully compliant
Creation of project automatically from customer order.	SCC LIMS create project automatically taking details from customer order (with each instruments as independent task for calibration)
Work Load Management	SCC LIMS allows project progresses to be updated automatically (defined at application level) or manually based on milestone plan. Project administrator can refer to dashboard view wrt how many Jobs are already assigned and the progress made in those jobs before assigning new job to the engineer.
Effort tracking	SCC LIMS time to be logged against each of the job created by the LIMS module
Deadline management and timeline tracking	SCC LIMS project allows progress to be tracked in graphical format, GANTT chart, as well as all the jobs progresses in term of %age could be tracked via easy to report MIS module
Automatic Notification wrt upcoming re-calibration of Standard Reference Instruments	SCC LIMS sends automatic mail to Lab Managers wrt all standard instruments that are due for re-calibration in pre-defined number of days
CRM (Allowing prospect to be managed from within the application, quotation, customer service order, invoice to be generated from within application	Fully compliant
Invoice/Billing item lines could be generated from calibration service order assignment, listing all the products tested/calibrated alongwith certificates or report numbers in second line	Fully compliant
Web Access to application from anywhere.	SCC LIMS is web based application only thus it is available through internet only from anywhere and on any device (including smartPhones)
Invoice generation on completion of project.	SCC LIMS allows user to send mail informing all the stakeholders (account team) when project is closed formally on the LIMS
Managing prospect and lead generation.	SCC LIMS campaign management features allows users to manage and enroll new prospects and can schedule events on sales rep calendar about the upcoming renewals of certificate of calibration for instrument calibrated earlier thus helps in retaining existing customers

Inventory Management

Inventory Management: Inventory should be managed of the instruments as well as sample stock received.	Fully supported; for Calibration: manage lab inventory of standard instrument as well as manage inventory of lab customer instruments (with all details including its past traceability records. For Testing: Manage inventory for Samples received/consumed and regents stock, automatic alert when regent goes below minimum defined threshold.
Standard Instrument Certificate Expiry notification	Fully supported for Calibration, LIMS can schedule a report to list upcoming re-calibration dates
Restrain engineers to use expired or out of governance standard instruments	Fully supported for Calibration, the system flash error and does not allow engineers to save observation data if Standard selected are out of governance on certificate validity basis

Material Testing Labs specific requirement

Batching, LABS receive samples from many batches that need to be kept recorded and managed accordingly	Fully Supported
Chain of custody is primary requirement from audit trail perspective and for keeping evidence control	Basic functionality included in standard product

Integrated QMS, OSS and CAPA (Optional Modules)

Out of Specification (OSS) should be highlighted to the process owners	OSS mail is sent to all the process owners that have worked on the product till the detection stage
OSS incident get logged on the application log automatically	Fully supported, LIMS application can create an incident automatically when it find “out of specification” test results logging onto the application
QMS:Ablity to log incidents manually of various types	User can log incident of various type such as Non conformance, Auditor review, suggestion,OSS etc. Any other type of incident type can be added by the users
CAPA: Provision to log impact analysis of the incident on business by all the process and management	Authorised users will be able to log their own assessment of incident on the CAPA register
CAPA: Provision to log causal analysis by respective process owners and also the floor managers with predefined categories (process/people/material etc)	Authorised users can log their views on possible cause that might cause causal analysis, list of possible cause categories can be defined by the QA department themselves
CAPA provision to log root cause from al the causes logged	Supported
Mitigation Plan log along with its end date	Mitigation plan can be documented and a predefined note on delayed actions will be relayed to the QA department and process owner responsible for taking actions
Effectiveness plan to be logged and tracked	Supported
Documenting CAPA or Incident Log	User can publish all the incident history in ODT document format that can be opened by MS Word or any other open document reader
MIS reports based on OSS or QMS	MIS such as supplier wise out of specification, ranking of supplier, machine or process could be generated with ease of generic report designer