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Our Capabilities

ERA Sciences for Life Sciences

Innovation is inevitable.

 

We work with clients to develop results-driven strategies for their digital transformation journey and help them achieve GxP compliance.

 

Helping to ensure your organization can adapt to technological advancements quickly, compliantly, and effectively with the right strategies!

What We Do

Science Lab

Prioritize Data

We know data is an asset for your company, and we are passionate about protecting the integrity of that data! Whether you use data for regulatory compliance or to drive business decisions, we help to ensure the management of your data is life cycle focused.

Optimize

We double-down on value-add activities and identify process inefficiencies for elimination across all stages of an application’s life cycle. We achieve this with agile and risk-based principles.

Empower

We empower professionals by addressing knowledge gaps. Our eFlex training allows knowledge sharing by our team of SMEs.

Realized Results

Clients have reduced system testing by 70% with no impact on quality assurance

Thought Leaders

Our team of experts are contributing committee members of PDA.org and ISPE.org

Empower Teams

Our learning material is used in the ICH Q9 (R1) Quality Risk Management training deck for both Subjectivity and Hazard Identification

Image by Ilya Pavlov

Training

Assessments

Program Development

Clinical Trials

Ensure the integrity of trial data to support your new drug application (NDA) with effective governance of IT systems appropriate for the phase of the trial.

  • Clinical Operations Data Governance

  • Statistical Software Governance

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

CTMS (Veeva CTMS, CDMS, eTMF)

Biostatistics (RStudio, Minitab)

Chemistry, Manufacturing, Controls

Enabling the consistent production of high quality drug products for consumers through GxP digital enablement

  • 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)

Mergers, Acquisitions

Maintaining business continuity during uncertainty while consolidating existing processes

  • System gap assessment & analysis

  • Validation framework consolidation

  • Lean migrations using sampling

  • System decommissioning

Our Process

Single Learner Engagement

Group Learner Engagement

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