SOPs

Doc #	Document Description	Rev #	Effective Date	AIDs Artwork Assay Assembly Audit External Forms Labels Manuals MSDS NPC Obsoletes PBRs Protocols Release Notes Reports Specs SOPs Tech Bulletins Validations
*BioInformatics*
1030-001	Software Testing Process	R00	12/13/01
1045-005	Bringing Down the LIMS Production Server	R00	02/13/02
E1045-007	Training Procedure, Part 1 for LIMS (Engineering Release)	RX1	01/17/02
1045-009	biflex™ RT Configuration	R03	07/23/02
1045-016	MassARRAY™ Link Station Sample Tracking Installation	R02	09/04/03
1045-017	Server Configuration	R02	02/25/03
1045-018	MassARRAY™ RT/Server/Client Sample Tracking Installation	R02	09/04/03
*Calibration*
0745-007	Calibration Stamp Control	R00	07/09/02
0745-009	Control and Maintenance of Inspection, Measuring and Test Equipment, Measurement Standards and Associated Certificates	R01	10/21/02
0745-011	Calibration Procedure for MJ Research Precision Resistors	R00	10/21/02
0745-012	Calibration Procedure for MJ Research Temperature Probes	R00	10/21/02
0745-013	Calibration Procedure for Balances	R00	10/21/02
0745-014	Calibration Procedure for Freezers/Refrigerators/ Ovens/Temperature Alarms/Temperature Chart Recorders/Water Baths	R00	10/21/02
0745-015	Calibration Procedure for Timers	R00	10/21/02
0745-016	Calibration Procedure for Centrifuges	R00	10/21/02
0745-017	Calibration Procedure for Model RSU Resistance Substitution	R00	10/21/02
0745-018	Calibration Procedure for Immersion Type Thermometers	R00	10/25/02
0745-020	Calibration Procedure for Pipettes with Nominal Value Greater Than 50µL, Repeaters and Bottletop Dispensers	R00	10/21/02
0765-002	Offsite Equipment Repair Request	R00	06/04/02
7045-044	Calibration Procedure for CO2 Incubators	R00	06/03/03
7045-045	Calibration Procedure for pH Meters	R00	06/12/03
7045-046	Calibration of Applied Biosystems 96-Well GeneAmp^® PCR System 9700	R00	08/12/03
7045-047	Calibration of Applied Biosystems Dual 384-Well GeneAmp^® PCR System 9700	R00	08/12/03
7045-048	Calibration Procedure for Humidity Indicators	R00	08/12/03
*Customer Support*
2045-001	Installation and Maintenance of SpectroPOINT™	R04	09/25/01
2045-005	RT TCL Software Interface Upgrade Procedure	R00	08/16/01
2045-008	MassARRAY™ System hME Training	R00	09/25/01
2045-009	SpectroPREP™ Training	R00	09/27/01
2045-010	SpectroJET™ Training	R00	09/27/01
2045-011	SpectroPOINT™ Training	R00	09/25/01
2045-012	SpectroREADER™ Training	R00	09/27/01
2045-013	SpectroTYPER™ Training	R00	09/27/01
2045-014	SpectroCHECK™ Training	R00	09/25/01
2045-016	Installing Registry Key Controlled Software	R00	09/12/01
2045-020	SpectroPREP™ Installation	R00	05/01/02
2045-023	SpectroREADER™ Installation Procedures	R02	07/19/01
2045-031	Establishing and Maintaining Customer Pricing	R00	10/18/01
2045-032	SpectroCLEAN™ Resin Dispenser Assembly, Pre-Qualification, QC and Shipping	R00	02/07/02
2045-033	TOF Software (Version 5.0.25) Upgrade Procedures	R00	12/11/01
2045-038	Customer Feasibility Study Guidelines	R00	07/19/01
2045-039	MassARRAY™ System Installation	R01	05/09/02
2045-040	SpectroREADER™ Pre-Installation Procedures	R02	07/19/01
2045-042	SpectroTYPER™ RT Installation Guide, biflex Version	R02	11/21/01
2045-043	Field Service/Customer Support Reporting	R00	05/17/01
2045-044	Use of the Site Requirement for the MassARRAY™ System Document	R01	05/09/02
2045-045	SpectroREADER™ Networking Procedures	R03	09/25/01
2045-046	SpectroCLEAN™ Resin Dispenser Installation and Functional Check	R00	02/07/02
2045-047	HTP hME SpectroPREP™ Installation Guide v2.0	R00	02/04/02
2045-048	MassARRAY™ RT Software Installation Guide (autoflex^® Version)	R02	03/24/03
2045-049	hME SpectroPREP Installation Guide (Resin Dispenser Macros)	R00	02/07/02
2045-052	How to Create a Sales Order in the BaaN Operating System	R00	06/25/02
2045-053	SpectroACQUIRE Barcode Calibration Guide	R02	09/04/03
2045-054	MassARRAY™ Genotype Analyzer (autoflex) Installation Procedures	R00	03/24/03
2045-055	Installation and Maintenance SOP for MassARRAY™ Nanodispenser	R01	04/25/03
2045-060	MassARRAY™ Nanodispenser S Upgrade Kit Installation Procedures	R00	07/25/03
2045-061	MTP Hotel Troubleshooting Guide for Nanodispenser HT Unit	R00	07/29/03
2065-001	Return Material Procedure	R00	07/23/02
*Facilities*
0745-001	FM - 200 Training	R01	08/27/02
0745-008	Equipment Lockout/Tagout Procedure	R00	07/30/02
0745-010	Mechanical Maintenance Procedure	R00	10/25/02
0745-019	Calibration Stamp Control	R00	01/13/03
0745-021	Calibration Procedure for Immersion Type Thermometers	R00	01/13/03
*Finance*
0845-001	Standard Cost Price Update	R00	01/08/02

*Human Resources*
0745-001	FM - 200 Training	R00	09/25/01
1545-001	Termination Procedures	R00	06/18/01
*Manufacturing*
6045-004	Label Format
6045-015	Gowning for Manufacturing Cleanrooms	R01	01/22/01
6045-019	Autoclave	R01	10/19/00
6045-027	Operation of the Fisher Accumet pH Meter	R01	12/15/00
6045-028	Final Goods Packaging	R01	11/15/99
6045-029	Kit Packaging Configurations	R07	03/01/02
6045-034	Matrix Application/Pouching	R11	11/15/01
6045-036	Line Clearance	R01	01/24/01
6045-038	Dispensing Procedure for Bottled Reagents	R02	06/04/02
6045-041	Labware Cleaning	R02	02/21/02
6045-043	Dispensing Procedure for Vialed Solutions	R01	05/22/01
6045-044	Installation / Operation Qualification (I/OQ)	R01	01/24/01
6045-045	Label Printing	R03	08/28/03
6045-047	Conductivity Meter	R01	07/20/00
6045-048	Mettler Balances	R01	01/22/01
6045-049	Chatillon Force Gauge	R01	07/20/00
6045-058	Piezo Pump Silanation	R07	05/30/01
6045-060	Cleaning Procedure for Plastic Chip Trays	R00	09/05/00
6045-061	Incoming Chip Inspection using an Automated Vision System	R02	02/27/03
6045-062	Centrifuge Evaporation (Speed Vap)	R00	09/14/00
6045-063	Disk/SpectroCHIP™ Gluing - Red Epoxy	R01	02/06/01
6045-064	SpectroCHIP™ Silanation - Red Epoxy	R12	02/25/03
6045-065	SpectroCHIP™ Rework Procedure	R03	11/09/01
6045-066	Convection Oven Operation	R00	11/29/00
6045-067	Measurement Variation / Rounding	R00	12/06/00
6045-068	Impact Marker Operation	R01	11/16/01
6045-069	Matrix Application/Pouching - 300 mM	R02	03/12/02
6045-070	SpectroJET™ Install Procedure, Manufacturing	R00	07/11/01
6045-071	Matrix-Applied Chip Inspection Using an Automated Vision Inspection Machine	R05	08/28/03
6045-072	Piranha Dispenser Operation	R00	08/07/01
6045-074	Cartesian Dispenser Operation	R03	07/16/03
6045-075	Cartesian Preventive Maintenance Procedure	R01	02/14/02
6045-077	Shop Order Generation	R00	10/29/01
6045-078	Enter Hours of Accounting	R00	02/21/02
6045-080	Cartesian Degasser Operation	R02	03/21/02
6045-081	CentriVap^®DNA System Operation	R00	03/12/02
6045-083	Packaging of Sequenom SpectroCHIP™	R01	08/28/03
6045-084	MassARRAY™ Nanodispenser (R) Barcode Tracking Upgrade Installation Procedure	R02	09/04/03
6045-086	4X hME Starter Kit Packaging Procedure	R00	09/16/02
6045-087	OEM Purification Kit Packaging Procedure	R00	02/20/03
6545-001	Inspector Disaster Recovery Procedure	R00	11/20/01
*Materials*
5045-001	Part History File Procedure
5045-002	Establishing Credit Account with New Supplier	R00	12/07/00
5045-003	Cleanroom Services	R01	06/01/01
5045-004	Central Stores Procedure	R01	06/01/01
5045-005	Return to Supplier (RTS) Procedure	R02	01/28/02
5045-006	Materials Receiving	R08	05/16/03
5045-007	Office Depot Set-Up/Ordering Procedures	R01	06/01/01
5045-008	ComDisco Ordering Procedure	R01	06/05/01
5045-009	Purchasing Controls	R03	06/28/02
5045-011	Incoming Quality Control (IQC)	R01	01/23/02
5045-013	Shipping	R03	08/01/02
5045-014	Packing of Shipment	R01	01/28/02
5045-015	Company Van System	R02	06/25/02
5045-017	Cycle Counting	R02	09/22/03
5045-018	Receipt/Storage Conditions	R02	01/28/02
5045-019	Supplier Corrective Action	R02	06/12/01
5045-020	Supplier Evaluation/Sustaining Support	R00	09/24/01
5045-021	Pre-Supplier Development System for SEQUENOM, Inc.	R01	05/22/02
5045-023	Forecast Usage Activity	R00	10/29/01
5045-024	Safety Stock Levels	R00	10/29/01
5045-050	Physical Inventory Counts	R04	09/22/03
5045-051	Inventory Movements and Transactions	R03	01/23/02
5045-052	Kit Pull Procedure	R01	01/23/02
5045-058	Shop Order Procedure	R00	02/21/02
5045-060	Shipment of SEQUENOM C Tube Oligos in Solution by IDT	R00	05/01/02
5045-061	Sealing and Shipping AB0862 Oligo Plates	R01	12/31/02
5045-062	Foam-in-Place Packaging System	R00	06/13/02
5045-063	RT Workstation Configuration	R04	03/25/03
5045-065	Controlling Inventory Items that Expire	R00	03/13/03
5065-002	Replenishment Order Control	R00	07/08/02
*Preventive Maintenance Manuals*
2040-001	Samsung Techwin MassARRAY™ Nanodispenser Maintenance Manual	R00	08/08/03
2040-002	Samsung Techwin MassARRAY™ Nanodispenser Operations Manual	R00	08/08/03
*Quality Assurance*
7045-001	Quality Assurance Documentation Format and Style Guide	R03	06/27/02
7045-002	Document Numbering for Quality System Documentation	R08	08/13/03
7045-009	Deviations to Quality Controlled Documents	R01	01/26/02
7045-012	Electronic Distribution of Controlled Documentation	R02	08/08/02
7045-014	Electronic Numbering Log	R02	02/20/03
7045-015	Intranet Web Site Maintenance	R02	02/20/03
7045-018	Quality Audit Process	R02	08/08/02
7045-023	Nonconforming Material Report	R02	01/23/02
7045-024	CD Production for Customer Product	R03	02/08/03
7045-026	Control of Quality Records	R02	02/20/03
7045-028	Training Database Maintenance	R02	08/27/02
7045-033	New Product Commercialization (NPC) Process	R00	07/24/01
7045-039	Use of Statistical Techniques	R00	04/16/02
7045-040	Issuance of the AQL Inspector's Rule	R00	04/12/02
7045-041	Product Hold System	R00	04/12/02
7045-043	Issuing Item Numbers in BaaN and performing Maintenance	R00	04/04/03
7045-049	Instructions for CD Sign In Sheet	R00	08/08/03
7045-050	Validation Planning	R00	08/13/03
7045-051	Verification Planning	R00	08/13/03
7045-052	Verification & Validation Planning	R00	08/13/03
7065-001	Control of Documents System	R01	05/28/02
7065-002	SEQUENOM, Inc. - Training	R02	08/27/02
7065-003	Quality Audit	R00	01/25/01
7065-004	Control of Quality Records	R03	02/18/03

7065-006	Supplier Quality Audits	R00	11/02/00
7065-007	Design Control and Validation Guideline	R00	11/30/00
7065-009	Change Order System	R02	08/12/03
7065-010	Using the SEQUENOM Training Database	R01	08/27/02
7065-014	Good Documentation Practices	R00	06/19/02
7065-015	Deviations to Quality Controlled Documents	R00	06/19/02
7065-018	Raw Material Specifications Procedure	R00	09/10/02
7065-019	Engineering Release	R00	06/19/02
7065-021	Generating and Maintaining Registry Key Data in BaaN	R00	10/24/02
7065-022	New Item Release in BaaN	R00	01/03/03
7065-024	Routing Procedure for Change Control Board (CCB) Documents	R00	08/12/03
7065-025	Electronic Routing/Review of Controlled Documents	R00	08/12/03
7065-026	Software CD Process	R00	07/24/03
7065-027	Customer Complaint Handling	R00	09/16/03
*Quality Control*
9045-001	Sample Testing in Quality Control	R01	07/31/02
9045-002	Sampling and Disposition of Raw Material	R01	07/31/02
9045-003	Operations Investigation of Out of Specification Results	R01	02/07/02
9045-004	Performance Verification of Agilent HP 6890 GC System	R00	10/26/00
9045-005	Determination of Acetonitrile Concentration in SEQUENOM's MALDI Matrix Solution	R01	01/23/02
9045-006	HPLC Method for Determining Concentration and Identity of Individual Oligonucleotides in 3 pt Calibrant, Liquid	R03	07/15/03
9045-007	HPLC Method for Determining Concentration, Identity and Purity of MALDI Calibrant Raw Materials	R02	07/15/03
9045-013	QC Testing of the SpectroCHIP™ for Contamination by MALDI TOF Mass Spectrometer Analysis	R02	12/12/02
9045-014	SpectroPOINT™ Pin QC	R01	04/23/02
9045-015	Determination of Acetonitrile Purity and Identity of Gas Chromatography	R00	01/15/02
9045-016	HPLC Method for Determining the Purity, Identity and Concentration of NTPs	R01	01/20/03
9045-017	Operation and Preventive Maintenance UV Spectrophotometer	R00	12/20/01
9045-018	HPLC Method for Determining Ammonium Citrate and 3-HPA Concentration in MALDI Matrix Samples	R00	01/23/02
9045-019	Determination of Identity for Calibrant Raw Material Oligos by MALDI-TOF	R01	07/15/03
9045-020	HPLC Method for Determining Concentration and Identity of MassEXTEND™ Mixes	R00	02/20/02
9045-021	HPLC Method for Determining the Purity and Identity of 3-HPA Raw Material	R00	08/25/03
9045-022	HPLC Method for Determining the Identity and Concentration of NTP's in SNP Discovery Cleavage Mixes	R00	01/09/03
9045-023	HPLC Method for Determining the Purity, Identity and Concentration of SNP Discovery Cleavage Mix Raw Materials	R00	01/09/03
9045-024	HPLC Method for Determining Concentration and Identity of Individual NTPs in Extend Mixes	R00	11/13/02
9045-027	Performance Verification of Agilent UV-visible 8453 Spectroscopy	R00	03/19/03
9045-028	HPLC Method for Determining Identity, Concentration and Purity of SNP Discovery Calibrant Raw Materials	R01	07/14/03
9045-029	HPLC Method for Determining Concentration and Identity of Individual Oligonucleotides in SNP Discovery Calibrant	R00	01/20/03
*Research & Development*
8045-001	GeSIM Operation Protocol	R01	02/16/99
8045-014	HPLC Method for Determining Ammonium Citrate and 3-HPA Concentrations in MALDI Matrix Samples	R00	07/19/00
8045-017	Homogeneous MassEXTEND™ (hME) Handoff to Operations	R01	12/13/00
8045-019	Laboratory Notebooks	R00	05/03/01
8045-020	Performance Verification of Agilent HP 1100 HPLC System	R00	12/20/01
8045-021	Amine Dendrimer Chemical Derivitization of H-Chips	R00	03/14/02
*Advanced Systems*
8545-001	Routine Use and Maintenance of SpectroREADER™ Biflex III	R00	10/20/00
8545-002	MassARRAY™ Liquid Handler Sample Tracking Installation	R02	09/041/03
8545-005	Microsoft Excel Processing of SPECTRAmax	R00	01/16/03
8545-006	MassARRAY™ 20K 96 Syringe Head Validation and Calibration	R00	02/10/03
8545-007	MassARRAY™ 20K Foil Sealer and Knife Replacement	R00	01/16/03
8545-008	MassARRAY™ 20K Solenoid Valve Validation and Calibration	R00	02/10/03
8545-009	MassARRAY™ 20K Resin Dispenser Validation and Calibration	R00	02/10/03
8545-010	MassARRAY™ 20K Resin Dispenser Refill	R00	02/10/03
8545-011	MassARRAY™ 20K SAFIRE Validation	R00	02/10/03
8545-012	MassARRAY™ 20K Excel Data Processing	R00	01/16/03
8545-013	MassARRAY™ 20K System Start Up, General Maintenance and Shutdown	R00	02/10/03
8545-014	MassARRAY™ 20K Thermal Cycler Validation and Calibration	R00	01/16/03
8545-015	MassARRAY™ 20K Nanodispenser Verification	R00	02/10/03
8545-016	MassARRAY™ 20K Incubator Verification	R00	01/16/03
Molecular Biology
8745-003	PCR Procedure for Research Development using Universal Primer Tags	R01	04/11/01
8745-004	Agarose Gel Electrophoresis	R03	08/07/01
8745-008	MULTIMEK™ Maintenance	R03	04/16/01
8745-010	Autoclave R&D	R01	04/16/01
8745-018	Temperature Verification System	R00	12/12/01
Product Development
E8845-001	HTP hME SpectroPREP™ Installation Guide v1.0 (Engineering Release)	R00X1	10/31/01
8845-002	Gel Prep and PCR Analysis	R00	10/01/01
8845-003	autoflex^® Alpha Testing Plan v2.0	R00	11/16/01
8845-004	QC Performance Check of SpectroCLEAN™ Dispenser	R00	12/07/01
8845-005	SpectroJET™ Installation/Operation and Performance Qualification Procedure	R00	04/12/02
8845-006	SpectroCHIP™ 2D Data Matrix Code Inspection	R00	09/19/02
8845-007	Verification of EC/H₂O Dispenser for Biological Testing	R00	11/13/02
8845-008	Carryover/Contamination Evaluation: 20K 96-Channel EXTEND Cocktail Dispense Station	R00	12/02/02
8845-009	Carryover/Contamination Evaluation: 20K EXTEND Cocktail Solenoid Dispense Station	R00	12/02/02
8845-010	Carryover/Contamination Evaluation: 20K Resin Dispense Station	R00	12/02/02
*Sales & Marketing*
0445-003	Commissions Granting and Payouts	R00	05/09/03