March 23, 2023
Pharma IT secures IT Consulting Frame Agreement with Danish Government
Pharma IT Secures Frame Agreement with Danish Government
Pharma IT is proud to announce that we have been awarded a significant framework agreement from the Danish government as part of a larger tender focused on IT Consultancy. This coveted framework agreement encompasses a range of critical IT consulting services, focusing on GxP, QA, and Laboratory systems.
The agreement covers tasks regarding IT and software solutions used for monitoring and diagnosing both human and veterinary diseases, IT solutions used in connection with research, and systems that support the aforementioned. It is expected that the agreement will primarily be used by the Statens Serum Institut.
“We are humbled by this achievement and committed to delivering unparalleled value through our consulting services. We extend our gratitude to the Sundhedsdatastyrelsen for their trust and confidence in our capabilities,” shares Søren Winkel, Pharma IT’s CEO, “This frame agreement signifies a new chapter in our journey to improve the standards of life science consulting and empower our partners with fit-for-purpose solutions that align with regulatory standards. We look forward to embarking on this exciting collaboration and leveraging our expertise to provide value on public sector projects.”
Common tasks listed under the agreement include:
- Ongoing monitoring and advice regarding standards, requirements, and guidelines within GxP IT (GAMP5 and Annex 11)
- Advice on requirements and guidelines between GcP IT QMS and Information Security Management System (ISMS) and Privacy Information Management System (PIMS)
- Advice regarding collaboration with system supplier during project phase and implementation, including configuration and migration
- Establishment and maintenance of the validation plan and validation documentation
- Establishment and maintenance of user manuals
- Advice on information security and data protection activities (GDPR) from an IT technical perspective
- Preparation of System Impact Assessments
- Processing of deviations, CAPA and change cases within GxP IT
- Driving, facilitating and/or carrying out risk assessments
- Establishing and maintaining system catalog for GAMP5 systems
- Reviewing and providing quality assurance of requirements specifications (URS) for GAMP5 systems during acquisitions, as well as evaluation of offers
- Reviewing and approving periodic reviews of GxP IT systems
- Advice on audits within GxP IT
- Carrying out audits within GxP IT
- Validation of IT systems (CSV)
- Validation of software
- Technical project management
Our expertise in GxP, QA, and Laboratory systems consulting is pivotal in helping our partners ensure that their use of IT systems aligns with existing and upcoming regulations and guidelines. We look forward to a fruitful collaboration.
About Pharma IT
Pharma IT is a one-stop consultancy shop providing services exclusively for the pharma, biotech, and medical device industries. Our consultants provide expert tailored assistance across all key areas of these industries including Management & Business Consulting, IT Consulting & Cloud Solutions, Automation & Analytics, Drug Development, Biometrics, Medical Device Consulting, Manufacturing Consulting, and Quality, Compliance & Security Consulting. We pride ourselves on our subject matter expertise, highly agile approach, and customer-orientation. This has made Pharma IT a trusted partner for nearly 100 companies across the Nordics.
For more information, visit https://pharmait.dk