back to listings SME Profile: Formpipe Life Science
Formpipe Life Science
13 Poplars Court, Lenton Lane, Nottingham, NG7 2RR
Welcome to Formpipe Life Science – Compliant software for the Life Sciences sector, designed, implemented and supported by life scientists
"Electronic quality management systems should be usable, reflect current regulatory processes and be on a stable technology. X-docs™ has been built and maintained to those requirements”
- Ready to Go: Out of the Box EQMS functionality including SOP documents, CAPA processes and Training records with quick and easy implementation
- Simply Compliant: Pre-Configured software designed for use in Life Science ONLY so validation is minimal and supported by Formpipe templates
- Powerful reporting: Allowing your system not only be a compliance tool but also drive Quality led business decisions. Reporting is adapted to meet your needs
“Complexity, volume and a high number of diverse users call for built-in power and configurability. Platina LS delivers enterprise level capabilities tailored for the Life Science industry regulatory requirements”
- Enterprise Platform: Enterprise content management platform where all your content with compliance requirements can be managed
- Scalable Single Platform: Single platform that can run on your infrastructure or can be managed in the cloud. Scalable from 100-30,000 users
- Reduce Complexity and Costs: Replace multiple IT systems with one to reduce complexity and costs, while maintaining compliance
“Given the massive volume increase of electronic records, storing digital content for decades so you can find it, read it, and maintain compliance, is both costly and complex. LTA can future-proof this for you.”
- Record and Data Retention: A preservation platform that allows for the archiving & retrieval of digital information whilst retaining the original integrity of the content.
- Find it Fast: Industry leading Elastic search results in easy search and retrieval of single or batch records from a huge number of starting digital formats.
- Long Term Compliance: Life Science record retention with permission access, confidentiality, data spoliation and destruction with full audit trail.
“Companies face major challenges when it comes to digitizing the growing mountains of inbound and outbound .pdf and paper documents. Legislation on electronic formats as well as customer requirements are constantly changing, and Enterprise Resource Planning systems often restrict what can easily be done. Lasernet solves these problems and many more”
- Reduces system management time: Lasernet allows you to spend more time concentrating on business rather than the process of input and output management
- Communication tool: Allows output management of content by designing, formatting & distributing documents created by ERP and other applications
- Compliant: Workflows can include required quality checks and 21CFR Part11 compliant signatures to meet Regulatory demands
“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 computer systems.”
- Expertise: Subject matter expertise with GxP compliance, quality systems and validation testing for IS/IT systems including traditional on premise, dedicated hosted, on-demand (cloud) and mobile devices and applications
- Audit and 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.
“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’ industry experience covering QA, QC, IT, production, laboratory operations, engineering and validation.
- Proven Success: Experienced in auditing, introducing and successfully managing GxP compliance and quality systems to EU (EMA), US (FDA), UK (MHRA) regulations and international guidelines such as ISPE GAMP® and ICH.
- Pragmatism: Implementation of agile Quality Management Systems (QMS) that are fit for purpose and tailored to meet our customers’ needs, recognising some of our customers work across multiple industry sector verticals.
“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: Put simply, our team will work with you to establish what your business needs to prioritise in respect of maintaining data integrity and how to achieve this. We can manage the auditing of your third-party service providers where there is shared responsibility for maintaining 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 when there has been a suspected or actual data integrity breach.
- Data Preservation: How do you preserve the integrity of your data from multiple systems, with multiple file types for the duration of time needed to satisfy the regulators, and still be able to find it and read it?
“By taking a new approach to how you archive, maintain and manage your data you can deliver organisational cost saving and achieve GDPR compliance. Learn more about how Long Term Archive can help you now and in the future.”
- Achieve GDPR compliance: Long Term Archive is GDPR compliant, future proof and delivers long term digital preservation of your data.
- Reduce operational costs: with LTA you can retire archaic and outdated systems that you currently maintain whilst improving organisational performance.
- Find it Fast: industry leading Elastic search results in the easy search and retrieval of single or batch records from a huge number of starting digital formats.