What we do
We are a provider of specialist consulting services to simplify complex process and technology environments to help Life Science organisations achieve their compliance goals. These services are delivered to customers either as a stand-alone service or in combination with Formpipe software solutions.
For the past 20 years, we have successfully delivered over 500 projects to our customers within the EU, US and Asia. We are proud to have been able to help our customers achieve their quality and compliance goals. Our commitment to working with our clients to provide tangible results is demonstrated through a high rate of repeat or retained service.
We aim to be a strategic partner that our clients can rely upon in the long term and are available to help during the hard parts of the compliance journey.
Computer Validation & Compliance
With over 30 years’ experience using risk-based methods to provide practical solutions to help our customers achieve GxP compliance with their ‘on-premise’, hosted, ‘on-demand’ and mobile IT systems.
Expertise
Subject matter expertise with GxP compliance, quality systems and validation testing for IS/IT systems including traditional on-premise, dedicated hosting, on-demand and mobile devices/applications.
Audit & Actions
Computer systems compliance audits, regulatory inspection readiness, gap assessments and action plans (21 CFR Part 11, EU Annex 11, GDPR and GAMP®).
Supplier Audits
Supplier audits (including SaaS, PaaS and co-location for internal and/or third-party service providers). Due diligence for outsourced organisation structures.
“Formpipe has successfully provided a flexible and thorough QA consultancy support and advice service on a variety of strategic IT projects within our business.”
Vice President, Quality Assurance
Quality Management
We have helped many regulated companies implement GxP quality systems, driving lean compliance and providing pragmatic quality management processes that deliver long term business benefit.
Subject Matter Experts
Team of GxP Quality and Compliance subject matter experts each with a minimum of 20 years' experience covering QA, QC, IT, production, laboratory operations, engineering and validation.
Proven Success
Experienced in auditing, introducing and managing GxP compliance and quality systems to EU (EMA), US (FDA), UK (MHRA) regulations and guidelines such as ISPE GAMP® and ICH.
Pragmatism
Implementation of agile QMS's that are fit for purpose and tailored to meet our customers’ needs, recognising some of our customers work across multiple industry sector verticals.
“The Formpipe team’s support enabled us to identify and appropriately manage our regulatory compliance challenges and assured that the final deliverables met the expectations of both the regulators and our company’s leadership team. Formpipe delivered a complex, high profile and business-critical project within time and budget and enabled our business to meet its improvement program objectives.
I would recommend Formpipe as a smart, agile business partner and service provider that delivers measurable results and performance benefit.”
Senior Vice President, Ranbaxy Global Quality
Data Integrity
As with all activities involved in the safe and efficacious manufacturing, research, support and clinical you need to fully understand the design of any system and the routine operation of it to make good risk assessments as to where the data corruption could occur.
Focus
We will help you with what your business needs to do to achieve and maintain data integrity. We can manage the auditing of your third-party service providers where there's shared responsibility for maintaining the integrity of records.
Discretion
Sometimes things go wrong and urgent remediation action is needed. Our trusted and proven team are able to work swiftly, discretely and effectively between your organisation and regulatory authorities.
Understanding Data Preservation
How do you preserve the integrity of your data from many systems, including some file types no longer supported, for the duration of time needed to satisfy the regulators and still be able to search it and read it? Simple. Ask us.
“We have worked with Formpipe over several years for FDA and EU regulated product validation and remediation activities, and their discretion and pragmatism have been invaluable.”
Head, Global Technical Operations, Novartis Vaccines & Diagnostics
Want to see more?
Feel free to contact us for more information about our products and their benefits for you and your organisation.
You can also book a demo using the form to the right. We would love to meet with you and discuss further!
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