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GxP compliance solutions for GMP/GLP labs

Proven GxP solutions to assure data integrity and compliance

Laboratories operating under GMP (good manufacturing practice) and GLP (good lab practice) regulations must follow FDA or regional regulatory guidelines to protect data integrity or demonstrate quality assurance of manufactured products. To be GxP (good practice) compliant, regulated labs using microplate readers in their workflows need to verify that they are functioning within operational specifications and that the data acquisition and analysis software complies with regulations for electronic recordkeeping.

Molecular Devices is a leader in comprehensive compliance solutions with microplate detection systems and software. Combined with validation services and support, our solutions assure data integrity.

GxP compliance solutions for GMP-GLP labs

Microplate readers for GMP/GLP regulated labs

SpectraMax Microplate Readers

SpectraMax Microplate Readers

Our SpectraMax microplate readers are the most cited and have advanced protein and cell biology research for over 30 years.

For GMP/GLP regulated labs, the readers come equipped with our industry-leading SoftMax® Pro GxP Software—making us your partner in compliance.

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IQ/OQ services and PM/OQ service plans

Installation qualification (IQ), operational qualification (OQ), preventive maintenance (PM), and repair coverage for microplate readers and washers.

IQ/OQ services and PM/OQ service plans preserve instrument documentation in a digital and compliant format. Ensure ongoing compliance of your Molecular Devices microplate readers and be audit ready with comprehensive validation, maintenance, and repair documentation

iq oq
iq

INSTALLATION
QUALIFICATION (IQ)

Verifies and documents all necessary components required for operation are received and properly installed in accordance with Molecular Devices installation protocols.

oq

OPERATIONAL
QUALIFICATION (OQ)

Tests every subsystem of the reader or washer including mechanical, electrical, and optical components to verify operating functions are in accordance to the Molecular Devices product operational specifications

pm

PREVENTIVE
MAINTENANCE (PM)

Each plate reader or washer is calibrated, inspected, and lubricated—any potential issues are proactively addressed. Our comprehensive multipoint inspection and testing ensures each microplate reader or washer meets our product operational specifications.

SpectraTest Validation Plates

The SpectraTest® Validation Plates provide automated, comprehensive, and traceable validation of microplate reader performance for absorbance, fluorescence, and luminescence read modes.

To maintain confidence in the standards, we recommend having validation plates recertified at one-year intervals.

  • SpectraTest ABS2 Absorbance Validation Plate
  • SpectraTest FL1 Fluorescence Validation Plate
  • SpectraTest LM1 Luminescence Validation Plate
  • Multi-Mode Validation Plate
  • Cuvette Validation Set
SpectraTest ABS2 Validation Plate
Automated

AUTOMATED FOR EASE OF USE

All test measurements and calculations are handled automatically by the SoftMax Pro GxP Software protocols. Should any of the measurement parameters fall outside defined limits, a test failure is reported with the suspect parameters identified.

Nist Nim

NIST AND NMIs TRACEABILITY

Our validation plates are traceable to National Institute of Standards and Technology (NIST) and National Metrology Institutes (NMIs).

Recertification

RECERTIFICATION SERVICE

Validation plates sent to us are cleaned, calibrated, and recertified according to ISO 17025 (ABS1, FL1, and LM1 plates), and returned with a new certificate of calibration

GxP software for FDA 21 CFR Part 11 compliant work

SpectraMax Microplate Readers

SoftMax Pro GxP Software

SoftMax Pro 7.1.1 GxP Software is our most secure software to help you achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.

spectraMax-i3

SYSTEM AUDIT TRAIL

  • The system audit trail tracks and records all actions for easy identification
  • Electronic signatures and date/time stamps provide paperless documentation
  • Filtering information simplifies quality control and handling during audits making data export to Excel unnecessary
spectraMax-i3

MICROSOFT SQL EXPRESS DATABASE

  • Enterprise-level document sharing with complete control over file access permissions
  • Windows folder permission system is no longer needed
  • Can be easily upgraded later to a regular SQL database for larger amounts of data
  • Reduced support required from IT departments
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DOCUMENT WORKFLOW AND STATUS SYSTEM

  • The paperless, document status system maintains data integrity with control over document workflows
  • Project teams can track documents while they are moving through development, review, release, and usage in a controlled environment

Software installation and validation services

Our software installation services verify and document that required components are installed to operational specifications. SoftMax Pro GxP Software can be installed on a single computer or on a multi-computer networked environment by our expert technical support or professional services team via remote access, respectively.

Our on-site SoftMax Pro GxP Software validation service supports FDA 21 CFR Part 11 guidelines and is conducted by our certified Field Service Engineer (FSE). Each step in the process will be carefully planned and executed.

Single Computer

SINGLE-COMPUTER SETUP

  • Best for small labs with five or fewer users with one microplate reader
  • All software components are installed on a single computer, which is used by all users for data acquisition, analysis, and user administration
Multi Computer

MULTI-COMPUTER SETUP

  • Best for labs with six or more users with multiple microplate readers
  • Data acquisition, analysis, and user administration may occur on multiple computers, which all connect to a database hosted on a central server

Citations

SoftMax Pro Software is the industry leader for microplate reader control and data analysis–12,300+ citations and counting!

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