Services

Training

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.

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Consultancy

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 

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Managed Services

A team of subject matter experts to meet your validation requirements and project timelines with redundancy to assure delivery 

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Learning options

Single learner engagement

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.

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Group learner engagement

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.

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Consulting support

With innovation in life sciences being inevitable, ERA Sciences develops results-driven strategies to support digital transformation, ensuring GxP compliance. Adapt to technological advancements quickly, compliantly, and effectively with tailored strategies for your organization.

Assessments

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.

Planning

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.

Capabilities

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.

  • Data Integrity oversight of your third parties, such as Contract Development and Manufacturing Organizations (CDMO)

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.

  • Clinical Operations Data Governance
  • Statistical Software Governance

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.

  • 21 CFR Part 11, EudraLex Volume 4 Annex 11, PIC/S, GAMP 5 (Ed2), ICH Q9(R1)
  • Data Integrity Governance
  • GxP Validation Framework (CSV)
  • Computer Software Assurance (CSA)
  • Test Execution Systems
  • Quality Risk Management (QRM)
  • Supply Chain Risk Management and Drug Shortage Prevention
  • Third-party Data Integrity Audit training
  • Software as a Medical Device (SaMD)

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.

Testimonials

bpc-skillnet

"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.

Gilead_Logo_1C_RGB_CMYK_POS

"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.

Gilead_Logo_1C_RGB_CMYK_POS

"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

logo-medtech-europe

"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.

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