Do you offer a Computer System Validation Service?

Yes, our experienced professionals perform Computer System Validation Services on various platforms.

Do you provide 21 CFR Part 11 compliant software?

Part 11 sets forth  criteria under which FDA considers electronic records,  electronic signatures and handwritten signatures executed to electronic records to  be trustworthy, reliable and generally equivalent to paper records and handwritten signatures executed on paper. These criteria include  audits, system validations, audit trails and certain documentation. Vendors (including  ourselves) cannot provide software that complies with all these Part 11 requirements.

We do provide software that has features (such as audit trails and electronic signatures) that enable customers to comply with various regulations, but only after the customer has gone through our Computer System Validation Service. We provide Computer System Validation Service for several instrument platforms. Instruments for which we offer Computer System Validation Service.

Where can the requirements be found based on my regulated status?
21CFR 58
ISO15189 ISO17025 CLIA
42 CFR 493
State of NY Dept. of Health
Quality Management System 58.31, 58.35 4.1.5, 4.2 4.2 493:903, 1357, 1405 QMS S1-S5
Lab Environment Controls 58.41-51 4.10.1, 5.1, 5.3, 5.8 4.11, 5.3, 5.5, 5.10 493:1252 GF S1
Verification of Purchased Products 58.83 4.6.2, 5.5.3, 4.6.4 4.6 493:1256 LE SA, REAF S2-S7
Controlling Computer Systems 58:185-195 4.3.2, 4.13, 5.3, 5.8, AnnexB 4.3, 4.13, 5.4.7, 5.5, 5.10 493:1283 LIMS S1-S10
Lab Equipment          
Validated/Verified 58.61-63 5.3.2, 5.3.4 5.5 493:1253 LS2-S5, S8
Maintained, Calibrated, Functional Verification 58.63 5.3.2, 5.3.4, 5.3.2, 5.3.4, 5.3.6, 5.3.7, 5.3.9-10 5.5, 5.6 493:1254-55 LS2-S5, S8
Training Record          
Supplier 58.29 5.1.2, 5.1.10-11 5.5.3 493:1423, 1455 HR S3
Lab Personnel 58.29 5.3.5 5.2, 5.3 493:1495 HR S3
Method Validation 58.120 (limited) 5.5 (limited) 5.4 Subparts Validation S1-S6
What is GxP?

GxP collectively refers to a set of quality-related regulations and guidelines that are followed by regulated industries such as pharmaceutical and life sciences to help ensure that products are safe and function as intended.

  • Good Laboratory Practices (GLP)—framework for conducting nonclinical laboratory studies

  • Good Clinical Practices (GCP)—framework for conducting clinical trials

  • Good Manufacturing Practices (GMP)—methods, facilities and controls used in the manufacture, packaging, labeling, storage, installation and servicing of products to ensure their safety and effectiveness

Quality Systems Chart

Is a risk assessment mandatory to be compliant with GxP requirements?

No, a risk assessment is not mandatory, although it does help customers optimize their validation strategy. In keeping with GAMP5, a risk-managed strategy will help reduce both the costs of validation and exposure to regulatory risk. We provide a Risk Assessment Service that can be a starting point to help you with your compliance efforts.

Which Invitrogen™, Applied Biosystems™, and Ion Torrent™ platforms have software that can enable compliance with certain GxP and Part 11 requirements?
Type Platform Enables Compliance? Qualification Services Computer System Validation Service
RT-PCR SDS 1.4/1.5 software on 7500 FAST Yes Yes Yes
RT-PCR SDS Enterprise 2.4 software on 7900 HT Yes Yes Yes
RT-PCR AccuSEQ™ software on 7500 FAST Yes Yes Yes
GA 3500 Data Collection 1.0 software, GeneMapper™ v 4.1 software Yes Yes Yes
GA 3x30 Data Collection 3.x software, GeneMapper™ v4.1 software Yes Yes Yes
Do you operate under ISO standards?

Yes, our software and platforms are developed under ISO 9001:2008 standards.

Is a vendor audit enough to ensure that software features such as audit trails and electronic signatures are all present and compliant?

No, a vendor audit is just one step in your validation process. FDA regulations provide that Computer System Validation involves testing the system in the customer environment, and is ultimately the customer’s responsibility. The customer is also responsible for implementing procedural and administrative controls for regulatory  compliance. The Risk Assessment Service provided by us includes a Computer System Validation that helps to identify computer system gaps and provides recommendations to improve your laboratory’s efficiency.

When does Part 11 apply?

21 CFR Part 11 applies to records, required by FDA’s regulations, that are in electronic form and are created, modified, maintained, archived, retrieved or transmitted. Part 11 also applies to electronic records submitted to FDA.

What is GAMP5?

Good Automated Manufacturing Practices Version 5 (GAMP5), specifies that regulated companies have the responsibility for documentation, approval, and compliance of each element of the computerized system lifecycle. GAMP5 provides that such companies utilize vendor audits to ensure quality of the product and development process. The guide also suggests that regulated companies maximize supplier involvement to help with gathering requirements, creation of functional and other specifications, system configuration, testing, support, maintenance, and system retirement.

How does quality system management differ among GxP?

SOP System Management
  • Site Management has oversight of SOPs

  • QAU verifies GLP compliance
  • Sponsor has the responsibility
  • Aids departments in drafting SOPs

  • QA approves SOP

  • Study Director responsible for scientific content

  • QAU inspects final report
  • QC issues certificate for authorizing use

  • Quality assurance unit reviews documentation

  • Study records include test and reference item characterization, receipt and expiration date, quantity received and used
  • Traceability, accountability, and reconciliation of materials
  • Verify strict material controls from warehouse arrival through final product

Facilities and
  • Prevention of cross contamination and mix-ups; separation of activities to assure proper study conduct
  • Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations and minimize adverse effects on quality of products

Facilities and
  • Facilities, equipment, and utilities should be qualified to assure adequate performance
  • Facilities, equipment and utilities should be qualified to assure adequate performance

  • Periodically inspect, clean, maintain and Calibration/Assure of consistent performance for equipment should be described in SOP and records maintained

  • Where possible; traceable to NIST
  • Calibration/Assure of consistent performance for equipment should be described in SOP and master plan available

  • Full life-cycle validation required
  • Full life-cycle validation required
  • Full life-cycle validation required

  • Vague indication
  • Method validation is essential

  • Sample for analytical purposes from each test batch should be retained
  • Mandatory to keep appropriate amount of reference materials from raw to finished

  • 3 types of inspections:

    • Study-based
    • Facility-based
    • Process-based
  • Sponsor Audit; looking at trial conduct, compliance to protocol, SOPs, GCP and applicable regulatory requirements
  • Personnel, premises, equipment, documentation, production, quality control, medicinal product distribution, complaint handling, recalls and self inspection to verify conformance with QA

  • Must audit “live” and “historical” sample preparation
  • Audit prior to starting clinical activities
  • Audit at site

  • Vague indication
  • Formal investigation detailed in SOP

How do GxP responsibilities differ?
Function GLP GCP GMP
Ownership Facility Management Sponseor Manufacture/Holder of Authorization
Responsibility Study Director Principal Investigator Qualified Person
Responsibility for "Production" Principal Investigator Pharmacist Head of Production
Quality Quality Assurance Monitor Quality Assurance Quality Control
Archive Archivist Archivist  
What are some frequently cited issues?

For Computer Computerized Laboratory Systems

Instrument   Software   Method

  • Inadequate equipment testing and calibration

  • No verification of outside contractor to complete and perform

  • No written procedure that includes requirement performance verification

  • IQ, OQ, OM never completed


  • Failure to validate

  • User access levels and poorly controlled

  • Ability to overwrite raw data

  • Failure to ensure e-records are trustworthy, accurate, and reliable

  • No established (or poorly followed) procedures for change control


  • Inadequate testing and calibration of the equipment

  • No reproducibility

  • No linearity tests

  • Documentation incomplete

What are the main cases of incorrect test data?

Do you offer flexible pricing plans?

Yes. To help you control validation costs, we offer discounts when you sign up for validation services on multiple systems. If you require further customization for your validation process, or a broader scope of validation services, please contact one of our sales or service representatives by email at, or via telephone at 800 327 3002 (toll free in the US only). To contact a compliance and validation expert directly, please email


What is an IQ?

Instrument Qualification (IQ) procedures verify at the time of the testing, that instrumentation is delivered and installed according to the stringent specifications set by Life Technologies, documenting the shipment integrity, components, and compatibility with the system configuration.

What is an OQ/IPV?

Operation Qualification/Instrument Performance Verification (OQ/IPV) verifies and records an instrument’s ability to meet specified performance criteria after installation, repetitive use, relocation, or other major service events. The OQ/IPV service involves comprehensive testing of the complete system using established conditions and known sample characteristics, verifying the accuracy and precision of the instrument. Instruments should be regularly tested to confirm high-quality performance and identify possible impact due to normal wear or inadequate user maintenance.

What is an FSE?

A Field Service Engineer (FSE) is an experienced and certified representative trained to repair and service Applied Biosystems™, Invitrogen™, and Ion Torrent™ instruments using only factory-certified replacement parts.

What is the Remote Service Center?

The Remote Service Center is a phone-in facility where senior service engineers aid in solving instrument and computer validation problems before an FSE is sent out to your laboratory. Often a Remote Service Center representative can help fix your problem quickly and easily, thereby eliminating the need for a field visit.