Ensure your business and systems meet regulatory standards without wasting time or resources.

INTRODUCTION

Validation, verification and qualification are time-consuming, difficult, and completely necessary for companies operating in regulated environments such as the manufacture of pharmaceuticals.

Our specialty knowledge in computerized systems, combined with many years of validation experience in strictly regulated operations (GxP, GAMP 5, ISO 13485, TR 80002-2:2017, etc.) enable us to help you establish cost-effective and high-quality validation strategies that meet your organization’s specific needs.

We possess broad and comprehensive experience of qualification, validation, and verification in all life science areas (pharmaceuticals, medical devices, veterinary medicine, and cosmetics).

We can support you from a preproject phase (requirements specification) through to the life cycle management phase of all types of computerized-system projects.

QUALIFICATION, VALIDATION & VERIFICATION

We offer customized validation solutions and strategies in quality assurance and validation. We can take on various roles, including validation manager, validation engineer, and test manager.

We tailor our services to meet your specific needs and requests, for example, by producing validation plans, validation protocols, traceability matrices, and reports or other relevant documentation. Areas where we can support you include:

  • Computerized systems such as manufacturing execution systems (MES), laboratory information management systems (LIMS), distributed control systems (DCS), and supervisory control and data acquisition control systems (SCADA)
  • Information technology infrastructure
  • Processing and production equipment
  • Laboratory equipment
  • Automation systems (water for injection (WFI), facility monitoring systems)
  • Support systems (internal testing systems)
  • Product validation
  • Cloud solutions, or software as a service (SaaS)
  • Learning management systems
  • Documentation systems
  • Method validation
  • Excel sheets

REQUIREMENTS MANAGEMENT

We have established processes for clear and quality-assured requirements management in areas such as.

  • Computerized systems
  • Information technology infrastructure
  • Laboratory information management systems (LIMS)
  • Processing and production equipment
  • Laboratory equipment
  • Medical devices
  • Automation systems

SaaS SYSTEMS

Software as a service (SaaS) is becoming increasingly available in the life science sector. Fast, flexible, and scalable solutions that meet customer needs, together with pricing models that support global collaboration, have changed the industry’s attitude toward cloud-based solutions.

Today, there is a wide variety SaaS opportunities, from sales and marketing to skills, documentation, and after-sales management services, as well as logistics and analysis of complex data sets from clinical trials (organized) or social media (unorganized).

We can help to ensure your organization maintains control, follows recommendations and complies with regulations. This allows you to take advantage of the latest technological developments without compromising quality.

SERIALIZATION

We can support your change management process to comply with laws and regulations concerning your production flow. We enable you to meet specific market regulations more quickly and efficiently, ensure your systems and technology are compliant, prioritize actions, and make long-term operational improvements.

Our services include:

  • Training, informational materials, and serialization guidelines
  • Identification of needs, strategy, and supplier options
  • Project management, from assessment through the bidding process to implementation
  • Validation management
  • Integration with existing equipment or systems and between suppliers
  • Automation services
  • Systems solutions for data storage
  • Change management for new processes
  • Quality assurance support

PRODUCT SAFETY & TEST

We are specialists in regulatory affairs and quality control affecting medical devices and in vitro diagnostic products.

Manufacturers developing safe and relevant products are required to adhere to a number of standards and regulations. Our consultants in this area can help you identify the specific requirements and standards that affect your product and make sure that the requirements for safety are ensured during development. We can establish test strategies, review your design, consult in incident reporting or help with whatever you need to make sure you are in compliance.

We offer services and solutions according to directives such as EU Medical Device Regulation/Medical Device Directive and In Vitro Diagnostic Regulation/In Vitro Diagnostic Directive, and standards like IEC 60601-1 and IEC 61010-1, ISO 14971 and other requirements and standards that specifically address product safety.

CONNECT WITH
AN EXPERT

Lina Stange
Lina StangeChief Quality Officer & Senior Specialist Consultant
Tel: +46 (0)8 50 30 45 85
Carl Adelsköld
Carl AdelsköldSenior Consultant
Tel: +46 (0)8 568 595 02
Postnord TPL har genomfört vårt mest komplexa projekt hittills, nämligen automatiseringen av Apotek Hjärtats varuförsörjning. Plantvision har ur ett kvalitetsperspektiv lett valideringen och hjälpt oss att kvalitetssäkra produktionen på ett föredömligt sätt under projektet. Ordning och reda på dokumentation, tydliga kvalitativa rapporter och en röd tråd genom arbetet resulterade i bl.a. två med beröm godkända inspektioner från Läkemedelsverket. Vi hade inte klarat att genomföra det på egen hand.
Daniel Eriksson, TPL PostNord
As Project Leader you want to move forward quickly. But they have the strength to stop, reflect on the situation and motivate actions needed to ensure quality.
Harald Schneider, Imanet
They fulfil the very high demands we place on our consultants, both in terms of competency and personal qualities.
Said Diarbakerli, Regulatory Compliance Officer, AstraZeneca

MEDIA CENTER

GO TO MEDIA CENTER

Learn more about our Quality & Compliance offering

Get in touch, request more information
or sign up for our newsletter

CONNECT