Bringing a new product or treatment to market can mean an investment of many years and millions of dollars for a pharmaceutical or biotechnology company. This research and discovery traditionally has been conducted and witnessed through paper-based processes, but leading-edge companies are turning to electronic laboratory notebooks (ELNs) and intellectual asset management applications to innovate faster and get products to market more quickly. But if you aren't protecting the integrity of your developed formulas and other content, you risk losing ownership and consequently, your business if you can't prove authenticity.
“The vital nature of patents means that our electronic records must stand up to a legal challenge at any point in the future.” – Andy Sheppard, Head of Operations, Ferring Pharmaceuticals
Protect Scientific Intellectual Property from its Earliest Stage
To accelerate their products’ time-to-market, R&D-driven organizations must use the latest laboratory automation technologies while protecting vital intellectual property and trade secrets. Also, they must meet current and emerging regulatory requirements. Therefore, it is critical for companies to guarantee that the documents supporting their intellectual property and trade secrets are authentic and legally verifiable.
In R&D departments, laboratory notebooks are typically used to collect data, record experiments and prove ownership of an invention or trade secret. Electronic lab notebooks have penetrated over 20% of all biopharmaceutical companies.
As more labs migrate from paper lab notebooks to sophisticated, highly collaborative and automated electronic workflows, company trade secrets and confidential ideas are harder to protect...or worse, harder to keep inside your organization. How do you prove you own your scientific intellectual property, and that your electronic records and experimentation data haven't been altered? In the paper environment, scientists would "sign and witness" the research of their peers...hardly an enjoyable, reliable or productive use of time. With Surety's AbsoluteProof, you can incorporate this attestation process inside your electronic workflow. And with Surety's Legal Defensibility Guarantee, you can prove that your scientific intellectual property is yours and that it was never altered or manipulated, strengthening your legal posture.
AbsoluteProof is integrated into a number of market-leading electronic lab notebooks, including OpenLAB ELN from Agilent, CERF ELN from Rescentris and eNovator ELN from Kinematik.
“To ensure the trustworthiness of electronic records, effective management controls must be in place to guarantee their timing, integrity, and authenticity. One must not only secure data against theft or alteration, but be able to prove when the record was created, who created it, who approved/signed it, detection of any changes, and an auditable trail of the record’s lifecycle.” - Michael Elliott, President of Atrium Research and Consulting.