16+
countries
86+
customers
203+
projects
40+
yrs of industry experience
About Us
We help companies manage regulatory compliance through seamless integrations of best-of-the-breed DMS, QMS, LMS, ERP and LIMS on cloud or on premise. The integrations and services offer better customer experience and business efficiency.
Our
SOLUTIONS
GxP Printing
Print Control Services TM (PCS)
FDA says, "If it isn't written down , then it didn't happen".
Print Control Services consists of two components, Controlled Print Services (CPS) and Issued Print Services (IPS). Prints are completed in real-time and both services are necessary to meet Data Integrity Guidelines (21CFR 211.192, 211.194, 212.50, 212.70.f.vi and EMA Guidance GMP) for regulatory agency audits. This is compatible with cloud and on-premise environment.
Issued Print Services TM
IPS allows businesses to seamlessly
manage
prints and reprints of GxP
documents (Example: Validation protocols and Batch
records). It also allows reconciliation of executed issued
prints
and reprints.
Controlled Print Services TM
CPS allows businesses to seamlessly
manage
prints and reprints of GxP
documents (Example: SOPs, WIs). It also allows
recall of controlled prints and reprints.
DMS-LMS
Proficio TM
Proficio allows integration of DMS with one or more Learning
Management
Systems (LMS) either on-premise or cloud. It also enables
bi-directional
data exchange in real-time to maintain compliance.
Effortless control
Configurable versus customized
Seamless Experience
Connection with multiple LMSs (could
be GxP and
non-GxP)
Log every step
Easy to implement pre and post
approval business
rules
DMS-QMS
Synapsys TM
Synapsys solution allows businesses to connect, in real-time with a
DMS
repository
and Quality Management System (QMS) of choice.
Quick integration
Connect DMS and QMS for
end-to-end
capability with minimum manual
hand-offs
Minimize time & cost
Leverage preconfigured connectors,
reducing
implementation time and cost.
Always Ready
Synapsys leverages QMS and DMS
functionality and creates an exchange
of information at the appropriate time and on
an as needed basis.
Our
SERVICES
Implementation Services
Technology Services - With our 25+ years of
regulated
industry experience
and track record, we specialize in
implementation, upgrade and migration services. Examples of technologies
include
Documentum,
TrackWise, M-Files,
MasterControl and others.
Validation Services
We are fully equipped and positioned to offer
Product
Development and full
Computer System Validation Life Cycle
Management based on SDLC and GAMP5.
Enterprise Content Migration Services
Data migration services - With a vast range of ETL
migration tools and
frameworks, we offer an end-to-end qualified and
repeatable migration services.
Consulting Services
Our experienced professionals are experts and highly
capable of providing
business process consulting and technology
services.
Technology
PARTNERS
Client
TESTIMONIALS
“OpenText Documentum for Quality and Manufacturing
enhanced our regulatory systems with process
automation, greater control, better reporting and quick,
easy access to documentation.”
“A huge benefit of having integrated Documentum® and TrackWise EQMS® is the ability
to have
real time visibility into the end to end quality process and associated content
which enables
prompt action if needed.”
Talk to us
Impact Systems, Inc
2116 Braken Ave
Wilmington,
DE 19808
USA
Impact Systems Pvt. Ltd.
20, Durve House Society
Pune, Maharashtra 411037
India
Spaces, Olympia Tech Park
Guindy, Chennai 600042
India
info@impactsystems.com
