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.
Our validation engineers will work in partnership with you to achieve and deliver the results you need.
Manage your needs in a cost effective way by using our resources in a flexible manner.
We provide Project Management expertise for software and equipment validations, in addition to providing resources to work across the validation life cycle.
Our Quality Management System is ISO 9001:2015 certified, ensuring we deliver to the highest industry standards.
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.
For on site engagement your organisation benefits from the strong team culture fostered at Dataworks as our team integrate into your organisation.
Highly qualified resources with extensive experience working within the highly regulated Life Sciences Sector.
On-boarding of contract resources is easier for you to manage as our skilled and experienced engineers integrate seamlessly with your team.
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.
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.
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 can provide you with the following equipment validations depending on your requirements:
Most often used in the validation of PC equipment and includes the verification of software and hardware.
Includes validating the controls
that operate the machine along
with the software used.
Testing the integration with
other software systems.
Incorporates testing both the
software and the machine.
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.