Utilizing Digital Tools

Utilizing Digital Tools

Adopting digital technology across the different areas of the business is critical for our clients to deliver the highest value. 

Digital transformation means adopting tools to ensure organizations leverage the best of today’s technologies to serve their goals and deliver efficiently. 

At the outset of digital transformation work lies an extensive analysis of the company’s current state, followed by developing a digital strategy and roadmap. An essential aspect of digital transformation we support is designing and personalizing workflows according to business needs, such as corporate, research, clinical development, and regulatory. This ensures we are well positioned to meet a challenge often faced by our clients: ensuring compliance between the old and new systems across different businesses and technical divisions. 

How can ProductLife Consulting help your digital transformation?

How can ProductLife Consulting help your digital transformation?

We offer end-to-end service, from road map building to process design and partner selection, when our client needs to work with a vendor for the implementation. 

We bring experts with hands-on experience to the processes in many areas, including product development, clinical operations, regulatory affairs, commercialization, manufacturing, and corporate strategy. 

IT Services

IT Services

Domain-specialized IT experts and solutions for the pharma, biotech, and medical device industries.

We help you to leverage modern IT solutions, minimize risk, and ensure regulatory compliance. Our expert consultants are specialists in navigating technical IT and regulatory challenges within the pharma, biotech, and medical device industries. We are a tech-agnostic organization with expertise in all the industry-leading software and innovative solutions. From utilizing cloud-based solutions to ensuring compliance with GDPR – we have you covered.  

Our IT Services span the following key areas: 

  • IT project management
  • IT quality, compliance, and security
  • GxP cloud services
  • Veeva services
  • Test automation
  • Laboratory informatics

IT project management

IT project management

Our IT project managers have over ten (10) years of experience as PMs within the pharma domain. We can support you with a wide range of tasks, ensure on-time delivery, and be trusted partners in your projects. 

IT quality, compliance, and security

IT quality, compliance, and security

Assistance with services within all areas of quality and compliance, including quality management system(s) (QMS), computer system validation (CSV), supplier audits, vendor Assurance, GMP Compliance (Mock) Audits, Qualification/Validation services, compliance strategy development, 21 CFR part 11/Annex 11 compliance & IT validation, standard operating procedures (SOPs), data protection officer (DPO) services, GDPR, etc. 

GxP-validated cloud-based solutions

GxP-validated cloud-based solutions

Ennov-based offerings for electronic document management (EDMS), QMS and training management system (TMS), clinical information management (CTMS/eTMF), and regulatory information management (RIM/IDMP, eCTD), as well as Argus and/or HALO PV for pharmacovigilance and safety 

Veeva Services

Veeva Services

We have certified Veeva consultants to assist with implementation, post-implementation support, system maintenance, and release management. Pharma IT is a Veeva-certified services partner for the development cloud.

Test Automation

Test Automation

Harness the power of low-code test automation and test management through Azure DevOps and Leapwork. Automate user acceptance tests and increase compliance. 

Laboratory informatics

Laboratory informatics

Our consultants have over a decade of experience working with laboratory data in non-regulated and regulated areas. Pharma IT consultants are knowledgeable in instrument raw data, ELN, SMDS, LIMS, CDS, and small computerized systems.

Why choose PLG as your IT services partner?

Why choose PLG as your IT services partner?

EXPERTISE 

We are a global life sciences solution provider with expertise in multiple disciplines. Our IT consultants include both seasoned professionals and bright young talents who can support you with your IT application processes. We can tailor our services to meet your needs and budget. 

AGILITY 

Our IT solutions come GxP validated. This rapid deployment method saves the client from downtime and subsequent loss and enables a fast return on investment. 

SCALABILITY 

We consider your current and future IT and data management needs by designing systems and providing solutions to grow alongside your company. We believe in the longevity of our designs to maintain consistency as a hallmark of greatness. 

KEY FIGURES

75+

IT consultants have assisted over 100 customers with IT services.

10 m

documents migrated; we have provided project management and business analysts for the data migration track from the customer’s legacy system to an industry-leading eTMF solution.

3-months

GxP validated cloud-based EDMS+QMS solution implementation with €0 up-front implementation cost.

We pride ourselves on working at the highest standard. Our goal is to maximize the ROI of your IT investments while ensuring compliance.

Søren Winkel

CEO, Pharma IT

Søren Winkel – Digital and IT Services