Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.
Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
Pyxa Solutions is an independent 3rd party SME that has supported several Pharma companies in implementing or optimizing Veeva Vault.
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Pyxa Solutions: Implementation and Optimization of Veeva Vault
1. Electronic Document Management Systems
DRIVING SUCCSSFUL SYSTEM IMPLEMENTATIONS
PYXA IS AN INDEPENDENT 3RD PARTY SME
THAT HAS SUPPORTED SEVERAL PHARMA
COMPANIES IN IMPLEMENTING OR
OPTIMIZING VEEVA VAULT
Pyxa works closely with both Business and IT to develop a framework that
ensures Business Processes are optimized and leveraged to drive system
configurations that are tested and accepted for use by the Business to ensure the
optimal outcomes delivery.
✔ Business Process with defined System Touch-
points
✔ File Guide: defines type, subtype,
classificaPon and other key metadata and
workflow requirements
✔ Permissions Matrix (System Roles and
ResponsibiliPes, Access Controls and Security)
✔ User Requirements SpecificaPon
✔ User Acceptance TesPng (scripts and
execuPon)
✔ MigraPon Management (oversight of mapping
and tesPng)
✔ Training Material (including Process Training,
Vault Video Tutorial, e-Learning, Mobile Quick
Reference, Instructor Led Training Sessions)
GAINING
EFFICIENCIES WITH
A ROBUST
PROGRAM GEARED
TOWARDS
IMPLEMENTING OR
OPTIMIZING
VEEVA’S VAULT
SOLUTIONS FOR
EFFECTIVE
BUSINESS
OPERATIONS
Core Program Deliverables
Independent 3rd party: Helping Companies succeed
with their Veeva Vault SoluPons
2. Case Studies
CASE STUDY: IMPLEMENTATION OF SUBMISSIONS/ARCHIVE VAULT
FOR A GLOBAL PHARMACEUTICAL COMPANY IMPACTING ~1700
USERS GLOBALLY
Pyxa supported the programs overall
Project Management Office (both for
weekly team meetings as well as
weekly sponsor meetings
Pyxa worked closely with the global
business teams to define the business
processes (including roles,
responsibilities, access and security
controls).
Pyxa worked closely with the clients
Informatics team to ensure Business
requirements were appropriately
translated to IT configurations.
Pyxa also supported the URS and UAT
(both developing and testing scripts).
Pyxa established a trusted relationship
with the client and proceeded to support
them in Instructor led training and on-
going system maintenance.
A Global Pharmaceutical Company made the decision to implement Veeva’s
Submissions Archive Vault. Pyxa Solutions was retained to support the
company with the end-to-end project. Pyxa was engaged at the start of the
project (well in advance of system implementation)
Working with this client was a
delight. Pyxa was engaged by the
clients informa9cs lead and Pyxa
worked closely with their Business
and IT teams accordingly
3. Case Studies
CASE STUDY: OPTIMIZATION OF PROMOMATS VAULT FOR A
GLOBAL PHARMACEUTICAL COMPANY IMPACTING ~50 USERS IN
THE US
Pyxa served as the Clients SME
(understanding and guiding both
business needs and translating them into
system requirements)
Pyxa supported the US Business Team,
working closely with the Global
Business Owner (not US based) to
optimize the system accordingly
A Global Pharmaceutical Company needed to Optimize Veeva’s PromoMats
Vault for use in the US. The system had been previously implemented for
Global Use, however, it was never configured appropriately for optimal use in
the US.
Pyxa was engaged by the
clients Head of Post-Marke9ng
Regulatory Affairs
to opera9onalize the
management of the 2253
process within the PromoMats
Vault
CASE STUDY: OPTIMIZATION OF SUBMISSIONS ARCHIVE VAULT
FOR A GLOBAL PHARMACEUTICAL COMPANY IMPACTING ~150
USERS GLOBALLY
Pyxa served as the Clients SME to
provide an overall framework for the
optimization of the Submissions Archive
Vault to streamline business operations
A Global Pharmaceutical Company needed to Optimize Veeva’s Submissions
Archive Vault for use globally. The system had been previously implemented
for Global Use, however, it was never configured appropriately to support the
companies business processes.
4. For more information, please contact:
Carol Rutkowski
Partner
Pyxa Strategic Services Lead
crutkowski@pyxasolutions.com
610-973-4141
Pyxa Solu*ons is
comprised of a
dynamic team of
management
consultants and
R&D subject ma<er
experts specializing
in cross-func*onal
R&D delivery
stemming from
ac*vi*es led or co-
managed by
Regulatory Affairs
WHY PYXA
Dalia El-Sherif, PhD
Partner
Pyxa Consulting Practice Lead
delsherif@pyxasolutions.com
610-909-8831
4
Pyxa is managed by a team of three seasoned
partners and comprised of a solid team of
consultants with prior blended exper*se in
industry and management consul*ng.
✔ Experience with Drug Development and
Lifecycle ApplicaPon submissions
✔ Proficiency in Leading Global Submissions
(knowledge of global guidances)
✔ Robust understanding of Business Processes
and ability to translate them into technical
requirements
✔ Specialized in several systems and able to
support cross system requirements, eTMF,
Publishing, Submissions Archive,
RegistraPon Tracking, PromoPonal Materials
Management, Submission Planning, etc.
✔ Leaders in content-based submission
documentaPon strategy