Validation Services

Over 25 years experience providing validation
services to leaders in in the Life Sciences sector.

Compliance and Quality are critical when you work in the Life Sciences sector.

Dataworks have over 25 years experience providing validation services to leaders in in the Life Sciences sector. Our manufacturing and software development expertise means that we can validate your equipment and systems to regulation ensuring that they are compliant with Good Automated Manufacturing Practice 5 (GAMP®5), FDA 21 CFR 11 and Annex 11.

Maintaining relationships with developers and communicating to
technical and non-technical people is key to the process.

Our validation engineers will work in partnership with you to achieve and deliver the results you need.

Why You Should Choose Dataworks


Manage your needs in a cost effective way by using our resources in a flexible manner.



Project Management

We provide Project Management expertise for software and equipment validations, in addition to providing resources to work across the validation life cycle.

Global Standards

Our Quality Management System is ISO 9001:2015 certified, ensuring we deliver to the highest industry standards.


Knowledge Transfer

We believe that this is critical in any engagement with our clients. It’s a key element of building partnerships with our clients which is mutually beneficial.

Strong Team Culture

For on site engagement your organisation benefits from the strong team culture fostered at Dataworks as our team integrate into your organisation.

Skilled Resources

Highly qualified resources with extensive experience working within the highly regulated Life Sciences Sector.


We Make Your Life Easier

On-boarding of contract resources is easier for you to manage as our skilled and experienced engineers integrate seamlessly with your team.

Computer Systems Validation

If you are increasingly relying on systems to perform a range of functions in your organisation as your organisation continues it’s digital transformation journey, the requirement to ensure that these systems operate in accordance with their specifications and comply with the standards of regulatory bodies and your Quality Management System is more critical than ever. We can help you achieve and maintain compliance.

With extensive experience in the validation of computer systems in pharmaceutical, medical device and medical supply facilities our validation team will ensure your systems are validated in accordance with GAMP®5 and FDA regulations including 21 CFR 11 and Annex 11.

Computer Software Assurance

The FDA have developed a new draft approach to validating software titled ‘Computer Software Assurance’ (CSA). CSA comes from a multi-year collaboration between the FDA and industry. The FDA’s thinking puts patient safety and product quality at the heart of the risk assessment process. CSA is a risk-based approach to validation that is more efficient as the validation cycle is shorter, the focus is on risk-based testing, and thus less expensive to execute. CSA has been utilised to validate non-product software applications in manufacturing environments. Examples in the literature of non-production software applications validated using CSA include:

  • ERP
  • Custom MES
  • QMS Systems


If the software vendor is already validating the software, why do in-house validation teams do it all again? CSA can be used to optimise testing efforts by focusing on the quality of the system by leveraging the vendors test documentation for COTS (Commercial off-the-shelf) system(s). CSA aims to focus on the intended use, with a focus on the testing, and not the scripting of tests.

At Dataworks our Validation team have developed the skills to perform computer application validations using the FDAs new CSA approach.  We analyse our customers’ requirements and using critical thinking identify risks according to impact to human safety, product quality or data integrity.  From the identified risks appropriate tests (scripted, unscripted and ad hoc scripts) are created and executed. 

Depending on our Customers’ needs we can validate your system using the traditional CSV method or by using the new CSA approach, please contact us to discuss what is the best approach for your project’s needs. 

Data Integrity

“it can be difficult to know where to start or if you will be compliant if an audit takes place”

If you are utilising automation and software systems to achieve compliance and help drive operational excellence, then complying with Data Integrity regulations is critical. 

Data Integrity is a hot topic in your industry with many of the regulatory bodies focusing on compliance with the regulations. It is essential that you have a robust Data Integrity strategy in place to ensure that you are compliant and have the appropriate data governance procedures in place.

Many of our validation team have strong technical skills and experience which gives them a much deeper understanding of the Data Integrity regulations and the impact they have on your governance and development and validation life cycles.

We can help you by conducting an audit of your software systems and data governance procedures, complete a gap analysis and a remediation plan if necessary – covering both the software and validation remediation. 

In addition to auditing your individual systems, we can perform a complete process data map across your automation, MES and enterprise level systems to ensure that you are compliant with regulations.

Data Integrity Offering Overview


Equipment & Automation Validation

GAMP (Good Automated Manufacturing Practices), and GAMP5 in particular set out procedures to ensure that automation equipment and software meet the required quality standard.

Our validation team has extensive automation, software and data integration experience and can ensure that your systems are GAMP5 compliance. 

We can also help ensure that your own internal policies and procedures are in line with the regulatory requirements.

We have extensive experience of working on large scale projects in the medical device and pharmaceutical industries across the various levels of the ISA 95 model.

Our team can work in partnership with you to complete FAT’s, SAT’s, Control Software Qualifications and the full cycle from Installation Qualification, Operational Qualification and final Process Qualification.

We have completed IQ’s CSQ’s FAT’s for equipment and software that controls equipment, some examples of these are:


We can provide you with the following equipment validations depending on your requirements:

Installation Qualification (IQ):

Most often used in the validation of PC equipment and includes the verification of software and hardware.

Controls Software Qualification (CSQ):

Includes validating the controls
that operate the machine along
with the software used.

Electronic Laboratory Notebooks:

Validation of ELN
Introduction of Barcodes scanning – replacing manual labels, printing barcoded labels and using barcode readers to scan into …

Factory Acceptance Testing (FAT):

Incorporates testing both the
software and the machine.

Tibbo Devices:

Installing Tibbo devices (Serial Device Support) onto 6 flow controllers, 2 new pH meters and 2 balances. These give the instrument’s IP addresses so we can print directly from the instrument into the Electronic Laboratory Notebook.


Validation of Empower. Installing a new version of Empower – replacing all existing LAC/E boxes with new ones and validating each one.

NuGenesis LMS
(Laboratory Management System):

Validation of LMS
Training Users in LMS
Introducing an Electronic Sample Management System
Introducing an Electronic Stability Management System

Technical Writing

Having worked extensively in pharmaceutical, medical device and medical supply environments for many years, our engineers can help you with all your documentation needs across a project. This can include project documentation, risk assessments, user and technical specifications, validation protocols and test scripts, and any operational SOP’s and or training manuals.

We can work closely with your team to deliver your documentation requirements that comply with your own policies and best industry practices. We offer a flexible engagement model where we can provide a turnkey solution or simply provide you with additional resources to work as part of your project team.

Validation Services Testimonial

“I truly appreciate the effort and dedication that went into this accelerated validation. We all knew the timetable was extremely tight, but frankly, you and Datawork’s ALWAYS deliver. Dataworks continues to be amongst our top suppliers and personally, my most trusted partner. I know the urgency of this work caused some shuffling of resources and demonstrates to our company your sincerest effort to help us achieve success. Thank you for being so diligent and supportive of us always.”

Vice President Applications, Development and Supply Chain