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Check out some of our free online courses or contact us to learn more
A comprehensive learning experience catering to virtual and in-person learning, on-site group training and workshops on best practice guidelines such as data integrity, risk, GAMP5 and CSA.
Specialist support in to ensure IT compliance with 21 CFR part 11, Annex 11, and GMP regulations, and effective governance of IT systems, with specific systems experience such as Veeva
A team of subject matter experts to meet your validation requirements and project timelines with redundancy to assure delivery
Create a free user account on the eFlex platform and get access to free or paid learning content. Complete the learning activity to gain certification in areas like data integrity training, 21 CFR Part 11 compliance, and ALCOA Plus or software validation and risk management.
Determine the best Grouped Learning Solution for your company and the optimum delivery method. Our instructor-led group workshop series for advanced topics, including GxP and life sciences training. Ask about group discounts.
Analyze data management practices and ensure compliance with 21 CFR part 11, Annex 11, and GMP regulations, and assess the overall risk management framework, including pharmaceutical data flow maps and 21CFR11 and supporting FDA 483 non-compliance remediation.
Ensure smooth transitions and effective management, providing change agents to facilitate governance upskilling and systems implementations that meet GMP, 21 CFR11, and regulatory standards for data integrity and clinical trials.
Ensure Clinical Trial Success
Maintain the integrity of clinical trial data to support New Drug Applications (NDA) through IT system governance. Solutions like Veeva and CTMS are aligned with the trial phase to meet regulatory standards.
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CTMS (Veeva CTMS, CDMS, eTMF) |
Enhance Clinical Operations
Receive full support for Data Governance, Statistical Software Governance, and Data Integrity oversight for third-party collaborations with CDMOs. Solutions include Veeva CTMS, CDMS, eTMF, and biostatistics tools such as RStudio and Minitab.
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CTMS (Veeva CTMS, CDMS, eTMF) Biostatistics (RStudio, Minitab) |
Streamline Chemistry Manufacturing Controls
Ensure consistent, high-quality drug production through GxP digital enablement, complying with 21 CFR Part 11, Annex 11, and GAMP5 regulations.
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Software Testing (Tricentis, Valgenesis, Kneat) DMS (Veeva, EtQ Reliance, MasterControl) QMS (Veeva, EtQ Reliance, MasterControl) LMS (Saba Cloud (SBX); ComplianceWire) eSerialization (Tracelink, Track & Trace) ERP (SAP) LIMS (Labware, Thermo SampleManager) CDS (Empower, Chromeleon, OpenLab) ELN (Labware, Biovia) Standalone Software (Cary WinUV, FTIR, Tiamo) MES (Rockwell automation) PV (Veeva) RIMS (Veeva) |
GxP Validation Frameworks
Leverage expertise in Computer Software Assurance (CSA), test execution, QRM, supply chain risk management, and drug shortage prevention to ensure compliant and efficient operations.
Third-Party Data Integrity Audits
Conduct thorough third-party data integrity audits and receive compliance training for areas such as Software as a Medical Device (SaMD), software testing, and eSerialization with TraceLink.
Tailored Software Solutions
Access expertise in leading platforms like Veeva, EtQ Reliance, MasterControl QMS, and LIMS systems like Labware and Thermo SampleManager.
Mergers & Acquisitions Support
Maintain business continuity during transitions with services like system gap assessments, validation framework consolidation, and lean migrations to optimize performance during uncertainty.
System Decommissioning
Ensure seamless system decommissioning with compliance and transitions managed across platforms like Rockwell Automation, Tricentis, ValGenesis, Kneat, and SAP ERP systems.
"The team at BioPharmaChem Skillnet were delighted to support ERA Sciences training workshops over the past year.
Feedback from our Life Sciences clients on ERA Sciences is fantastic and shows excellent trainer/trainee engagement and course material exactly meeting requirements.
BPCI Skillnet are looking forward to more engagement with the ERA Sciences team.
Highly accomplished in building learner expertise in data integrity and reliability, applying practical and successful risk based approaches"
BioPharmaChem Skillnet, a government funded organisation which sources, designs and delivers enterprise-led, subsidised training solutions in the BioPharmaChem sector.
"Whoever said learning is boring hadn't been part of an ERA Sciences training course!
Trainer made it highly interactive with worked scenarios relevant to our GxP regulated data and records management."
Gilead Sciences, A research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.
"Super easy for me to understand the more complex processes.
Already looking forward to attending another workshop later this year"
Individual Learner from Gilead Sciences
"Part of a data flow mapping session which has now added huge value to our company. Thanks again to the ERA Sciences team, feedback from a huge number of cross functional stakeholders has been excellent"
Learning Lead MedTech Client, The European trade association representing the medical technology industries, from diagnosis to cure.
Check out some of our free online courses or contact us to learn more
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